Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and would request that the University of California establish or designate an institute or office within the university to administer the program, which would be governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the program administrator to solicit funds from various specified sources for purposes of the program and would require the program administrator, upon receipt of at least $500,000 in funding, to establish the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and would request that the University of California establish or designate an institute or office within the university to administer the program, which would be governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the program administrator to solicit funds from various specified sources for purposes of the program and would require the program administrator, upon receipt of at least $500,000 in funding, to establish the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and would request that the University of California establish or designate an institute or office within the university to administer the program, which would be governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the program administrator to solicit funds from various specified sources for purposes of the program and would require the program administrator, upon receipt of at least $500,000 in funding, to establish the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and would request that the University of California establish or designate an institute or office within the university to administer the program, which would be governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the program administrator to solicit funds from various specified sources for purposes of the program and would require the program administrator, upon receipt of at least $500,000 in funding, to establish the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and would request that the University of California establish or designate an institute or office within the university to administer the program, which would be governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the board program administrator to solicit funds from various specified sources for purposes of the program and would require the board, program administrator, upon receipt by the program administrator of at least $500,000 in funding, to establish the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and would request that the University of California establish or designate an institute or office within the university to administer the program, which would be governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the board to solicit funds from various specified sources for purposes of the program and would require the board, upon receipt by the program administrator of at least $500,000 in funding, to establish the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and would request that the University of California establish or designate a nonprofit organization as an institute or office within the university to administer the program administrator program, which would be governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the program administrator board to solicit and receive funds from various specified sources for purposes of the program and would require the board, upon receipt by the program administrator of at least $500,000 in funding, to establish the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and would request that the University of California designate a nonprofit organization as the program administrator governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the program administrator to solicit and receive funds from various specified sources for purposes of the program and would authorize require the board, upon receipt of at least $500,000 in funding, to establish program the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and request that the University of California designate a nonprofit organization as the program administrator governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the program administrator to solicit and receive funds from various specified sources for purposes of the program and would authorize the board, upon receipt of at least $500,000 in funding, to establish program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 1823

Author:(Bonilla)

As Amended Ver:August 19, 2016

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Requests the University of California (UC) to establish and designate an institute or office with the authority to solicit and receive funds from business, industry, foundations, and other private and federal sources for the purpose of administering the Cancer Clinical Trials Program (the program) to increase patient access to cancer clinical trials. Establishes a five-member board to administer the program. Authorizes the UC to use its own state source funds for oversight and administration of the program relating to the initial start-up costs of the program only, provided the UC is reimbursed from federal and private sources funds. Requires the program, on receipt of funds totaling $500,000, to establish the Cancer Clinical Trials Grant Program (Grant Program) to increase patient access to cancer clinical trials in underserved or disadvantaged communities and populations. Limits administrative expenses to 20% of funds that are made available, but authorizes the use of more than 20% for the first year of the program. Allows UC to discontinue the program for various reasons.

The Senate amendments clarify requirements for persons appointed to the board, and provides for the use of funds for administrative costs, as specified.

FISCAL EFFECT: According to the Senate Appropriations Committee:

1. Start-up: Unknown one-time General Fund cost pressure for the UC to provide oversight and administration of the Program related to initial start-up activities. These costs are required to be reimbursed by moneys donated to the fund (federal or private funds) prior to awarding grants, thereby offsetting the use of state funds. This bill also provides that if the UC determines at any time that the moneys in the fund are insufficient to establish or sustain the Program, it may be terminated.
2. Unknown federal or private funds to administer the program and award grants. In order to have a viable program and offer services as described in this bill, UC indicates that funding would likely need to be in the millions. The scope of the program, including the number of grantees, grant amounts, and administrative support to operate the program would depend upon future donations.

COMMENTS: The author states that this bill seeks to remedy the problem of low patient participation in the federal Food and Drug Administration approved cancer clinical trials. More importantly, there are a disproportionately low number of patients in underrepresented communities including African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians. The author asserts this problem will be addressed by creating a privately funded state grant program to help patients pay for the ancillary costs associated with participation in these trials. Some of the barriers to patient participation in clinical trials include the following: lack of awareness of the available clinical trials, mistrust of research and the medical system, and loss of income. Clinical trials do not pay these ancillary costs associated with participation in a clinical trial such as transportation, hotel stays, and companion traveling expenses. The costs fall onto the clinical trial participant who may be unable to pay and therefore, unable to enroll in the trial.

Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 0003279

 THIRD READING  

Bill No: AB 1823

Author: Bonilla (D), et al.

Amended: 8/19/16 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 9-0, 6/22/16

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth, Wolk

SENATE EDUCATION COMMITTEE: 9-0, 6/29/16

AYES: Liu, Block, Hancock, Huff, Leyva, Mendoza, Monning, Pan, Vidak

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16

AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen

ASSEMBLY FLOOR: 80-0, 6/1/16 - See last page for vote

SUBJECT: California Cancer Clinical Trials Program

SOURCE: Lazarex Cancer Foundation

DIGEST: This bill requests the University of California (UC) to create a Board of Trustees of the California Cancer Clinical Trials Program, as specified, which would provide grants to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities, as specified. Allows the UC to decline to establish or participate in, and to terminate, the program, as specified.

Senate Floor Amendments of 8/19/16 clarify that, in the first year of the program, the program administrator may use more than 20% of program funds for administrative costs in order to establish the program.

ANALYSIS:

Existing law:

1. Establishes the Inclusion of Women and Minorities in Clinical Research Act, which requires a grantee, defined as any qualified public, private, or nonprofit agency or individuals conducting clinical research using state funds in conducting or supporting a project of clinical research, to ensure that women and members of minority groups, as specified, are included as subjects in clinical research projects.
2. Requires health plans and insurers to provide coverage for all routine patient care costs relative to the treatment of an enrollee or insured diagnosed with cancer and accepted in an FDA-approved cancer clinical trial (trial) if the enrollee's treating physician recommends participation in the trial, after determining such participation has a meaningful potential to benefit the enrollee or insured.

This bill:

1. Requests the UC to establish or designate an institute or office within the UC to administer the California Cancer Clinical Trials Program (CCTP) and to establish a Board of Trustees of the CCTP (Board) that:
   1. Consists of at least five members (who serve without compensation, with exception) appointed by the president of the UC to represent institutions and individuals performing, participating in, and supporting eligible trials in California;
   2. Has varying backgrounds to promote the purposes of the CCTP, including the ability and desire to solicit funds for the purpose of increasing and diversifying access to eligible trials;
   3. Is qualified through the experience, expertise, and diversity of its members in the design, implementation, and support of trials, and through studying and addressing socioeconomic, ethnic or racial, regional, and other barriers to participation, and interventions to remove those barriers;
   4. Makes efforts to include representatives of a range of public and private research institutions, health care providers, health care foundations, and patient advocacy organizations; and,
   5. Has an interest in increasing and diversifying access to eligible cancer clinical trials and the ability and desire to solicit funds for the purpose of increasing and diversifying access to clinical trials.
2. Requires a program administrator to establish the CCTP, upon the program administrator’s receipt of at least $500,000 in funding, to increase patient access to trials in underserved or disadvantaged communities and populations, including women and patients from racial and ethnic minority communities and socioeconomically disadvantaged communities.
3. Requires the Board to determine the criteria to award and administer grants, and allows the Board to award grants to any or all of the following:
   1. public and private research institutions and hospitals that conduct eligible trials; and
   2. nonprofit organizations that are exempt from taxation, as specified, and that either specialize in direct patient support for improved trial enrollment and retention, or engage in research on health disparities and their relationship to trial enrollment.
4. Requires grants to be used for activities to increase patient access to trials, including, but not limited to:
   1. Patient navigator services or programs;
   2. Education and community outreach;
   3. Patient-friendly technical tools to assist patients in identifying available trials;
   4. Counseling services for trial participants;
   5. Well-being services for participants, as specified;
   6. Payment of ancillary costs for patients and caregivers incurred during and related to participation to include, but not limited to, airfare, lodging, car rentals, meals, and dependent child care; and,
   7. Research on the effectiveness of these and other measures to increase patient access to trials.
5. Requires a program administrator to require grantees to submit any reports it deems necessary to ensure the appropriate use of funds. Allows the UC to require the Board to submit reports pertaining to CCTP and Board activities to the UC Regents, including, but not limited to, accounting of funds collected and expended, an evaluation of the CCTP, and recommendations regarding the CCTP.
6. Prohibits the program administrator from using more than 20% of program funds for administrative costs, except for in the first year of the program in order to fund the costs of establishing the program.
7. Encourages the Board, when determining grant recipients, to grant special consideration to public and nonprofit applicants that provide patient services related to trials that address health disparities or to applicants that possess two or more years’ experience in the improvement of enrollment, retention, or participation in trial participation with an emphasis on underserved populations.
8. Requests the UC to publicize to National Cancer Institute-Designated Cancer Centers, community organizations, hospitals, hospital associations, industry, health care foundations, and government agencies the opportunity to submit nominations for Board membership to the president of the UC. Requests the UC to publicize the availability of grants made available through the CCTP to the entities specified in 3) above.
9. Allows the UC to participate in the CCTP as the administrator, a beneficiary, or both, and allows the UC to pursue any federal, state, or internal approvals, authorizations, or advice it deems necessary to the UC’s participation. Allows the UC to decline to establish or participate in, and to terminate, the CCTP, as specified.
10. Allows a program administrator to directly or through a UC-affiliated foundation solicit funds from business, industry, foundations, research organizations, federal government agencies, individuals, and other private sources for the purpose of administering the CCTP and awarding grants to increase patient access to trials, consistent with guidelines developed by the Board.

Comments

1. Author’s statement. According to the author, this bill will help remedy the problem of low participation, especially for underrepresented communities, in trials by creating a grant program administered by the UC aimed at breaking down barriers to trial participation. The opportunity to assess and evaluate innovative treatments with participation from women and underrepresented individuals allows researchers to properly test the effects of medication resulting in the opportunity to develop robust treatments that meet the varying genetic make-up of women and men of diverse racial/ethnic groups. Unfortunately, there is currently no support for patients who want to access trials. The clinicaltrials.gov Web site is inadequate and not user friendly. Patients have found difficulty in navigating the Web site and are unable to find an appropriate trial that is suited for them and their disease state. Some of the barriers to patient participation in trials include the following: lack of awareness of the available trials, mistrust of research and the medical system, loss of income, transportation, and lodging costs. This bill will create the CCTP, which will grant money to nonprofits and research institutes focused on breaking down the barriers to trial participation.
2. Clinical trials. According to the National Cancer Institute, the largest sponsor of cancer clinical trials at 3,000 sites, over 30,000 patients are enrolled in trials annually. It is estimated that only about 3-5% of the 10.1 million adults with cancer in the U.S. participate in trials, however. A 2011 study published in the journal Annals of Surgery, based on data from the California Cancer Registry, found that less than one percent of cancer patients in California enroll in trials. Black patients, those older than 65, those with early stage cancer or with gastrointestinal or lung cancers were less likely to enroll than average. In 2004, the SELECT prostate cancer prevention trial completed recruiting over 35,000 men of whom 21% were minorities. According to a 2014 study in the journal Cancer, less than 5% of trial participants are non-white and less than 2% of clinical cancer research studies focus on non-white ethnic or racial groups.

Trials are a critical step in the discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. Without adequate representation of these populations in trials, researchers cannot learn about potential difference among groups and cannot ensure the generalization of results. In addition, participation in trials increases access to state-of-the-art cancer care, a critical survival factor in many minority and underrepresented populations that suffer disproportionately from cancer.

1. Issues with trial participation. According to a document published by the Society for Women’s Health Research and United States Food and Drug Administration (FDA) Office of Women’s Health, “Dialogues on Diversifying Clinical Trials,” the most important diseases that disproportionately affect ethnic minorities include type 2 diabetes, cardiovascular disease, stroke, infectious diseases (HIV/AIDS, STDs), and different types of cancer (colon, prostate, cervix, and lung). Many racial health disparities stem from lack of access to quality health care and proper health awareness. Unfortunately this means that incidence of disease does not always match trial populations. For example, African Americans represent 12% of the U.S. population but only 5% of trial participants. Hispanics make up 16% of the population but only 1% of trial participants. Sex distribution in cardiovascular device trials is 67% male. According to the American Cancer Society Cancer Action Network, only approximately 3% of adults diagnosed with cancer participate in trials, and the participation rate is lower for people who are racial and ethnic minorities, elderly, low-income, and live in rural areas.

The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified minority lack of disease education as a major barrier to recruitment. Other significant barriers to diversify enrollment, as reported by investigators and coordinators, are insurance status, patient inconvenience costs, availability of transportation, distance to the study site, and patient and family concerns about risk. However, race, age, and sex have been shown to play more significant roles in trial participation compared to proximity to trial location.

Prior Legislation

AB 1060 (Bonilla of 2015), was similar to this bill. AB 1060 was vetoed by Governor Brown who stated that numerous private organizations already perform this fundraising function, and while he supports eliminating barriers to take part in trials, he was hesitant to place this new burden on the Health and Human Services Agency (HHS) which is managing a huge expansion of our health care system.

AB 2038 (Alquist, Chapter 250, Statutes of 2000), enacted the Inclusion of Women and Minorities in Clinical Research Act to require any public, private or nonprofit agency conducting clinical research using state funds to ensure that women, including those over 40, and minority groups are included as research subjects. Requires that institutions conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee:

1. Start-up: Unknown one-time General Fund cost pressure for the UC to provide oversight and administration of the CCTP related to initial start-up activities. These costs are required to be reimbursed by moneys donated to the fund (federal or private funds) prior to awarding grants, thereby offsetting the use of state funds. This bill also provides that if the UC determines at any time that the moneys in the fund are insufficient to establish or sustain the CCTP, it may be terminated.
2. Unknown federal or private funds to administer the CCTP and award grants. In order to have a viable Program and offer services as described in this bill, UC indicates that funding would likely need to be in the millions. The scope of the CCTP, including the number of grantees, grant amounts, and administrative support to operate the CCTP, would depend upon future donations.

SUPPORT: (Verified 8/19/16)

Lazarex Cancer Foundation (source)

Association of California Healthcare Districts

Association of Northern California Oncologists

Business & Professional Women of Nevada County

California Academy of PAs

California Chronic Care Coalition

California Immigrant Policy Center

California Pharmacists Association

City of Hope National Medical Center

Community Health Partnership

Health Access California

Medical Oncology Association of Southern California

Pharmaceutical Researchers and Manufacturers of America

Susan G. Komen California Collaborative

University of California

University of Southern California

OPPOSITION: (Verified 8/19/16)

None received

ARGUMENTS IN SUPPORT: Supporters argue that currently only 3% of eligible cancer patients participate in trials, and of those patients only 5% are from underrepresented communities, including African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians. Supporters state that this bill allows researchers to properly evaluate the effects of new therapies and develop more robust treatments designed to meet the varying genetic make-up of women, men, and diverse racial/ethnic groups. Supporters further state that funds from the grants will help cover expenses stemming from trial participation, patient navigation, education and community outreach, and implementing patient-friendly tools to assist them in identifying available trials.

ASSEMBLY FLOOR: 80-0, 6/1/16

AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon

Prepared by: Reyes Diaz / HEALTH / (916) 651-4111

8/22/16 20:37:40

**** END ****

 THIRD READING  

Bill No: AB 1823

Author: Bonilla (D), et al.

Amended: 8/2/16 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 9-0, 6/22/16

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth, Wolk

SENATE EDUCATION COMMITTEE: 9-0, 6/29/16

AYES: Liu, Block, Hancock, Huff, Leyva, Mendoza, Monning, Pan, Vidak

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16

AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen

ASSEMBLY FLOOR: 80-0, 6/1/16 - See last page for vote

SUBJECT: California Cancer Clinical Trials Program

SOURCE: Lazarex Cancer Foundation

DIGEST: This bill requests the University of California (UC) to create a Board of Trustees of the California Cancer Clinical Trials Program, as specified, which would provide grants to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities, as specified. Allows the UC to decline to establish or participate in, and to terminate, the program, as specified.

ANALYSIS:

Existing law:

1. Establishes the Inclusion of Women and Minorities in Clinical Research Act, which requires a grantee, defined as any qualified public, private, or nonprofit agency or individuals conducting clinical research using state funds in conducting or supporting a project of clinical research, to ensure that women and members of minority groups, as specified, are included as subjects in clinical research projects.
2. Requires health plans and insurers to provide coverage for all routine patient care costs relative to the treatment of an enrollee or insured diagnosed with cancer and accepted in an FDA-approved cancer clinical trial (trial) if the enrollee's treating physician recommends participation in the trial, after determining such participation has a meaningful potential to benefit the enrollee or insured.

This bill:

1. Requests the UC to establish or designate an institute or office within the UC to administer the California Cancer Clinical Trials Program (CCTP) and to establish a Board of Trustees of the CCTP (Board) that:
   1. Consists of at least five members (who serve without compensation, with exception) appointed by the president of the UC to represent institutions and individuals performing, participating in, and supporting eligible trials in California;
   2. Has varying backgrounds to promote the purposes of the CCTP, including the ability and desire to solicit funds for the purpose of increasing and diversifying access to eligible trials;
   3. Is qualified through the experience, expertise, and diversity of its members in the design, implementation, and support of trials, and through studying and addressing socioeconomic, ethnic or racial, regional, and other barriers to participation, and interventions to remove those barriers;
   4. Makes efforts to include representatives of a range of public and private research institutions, health care providers, health care foundations, and patient advocacy organizations; and,
   5. Has an interest in increasing and diversifying access to eligible cancer clinical trials and the ability and desire to solicit funds for the purpose of increasing and diversifying access to clinical trials.
2. Requires a program administrator to establish the CCTP, upon the program administrator’s receipt of at least $500,000 in funding, to increase patient access to trials in underserved or disadvantaged communities and populations, including women and patients from racial and ethnic minority communities and socioeconomically disadvantaged communities.
3. Requires the Board to determine the criteria to award and administer grants, and allows the Board to award grants to any or all of the following:
   1. public and private research institutions and hospitals that conduct eligible trials; and
   2. nonprofit organizations that are exempt from taxation, as specified, and that either specialize in direct patient support for improved trial enrollment and retention, or engage in research on health disparities and their relationship to trial enrollment.
4. Requires grants to be used for activities to increase patient access to trials, including, but not limited to:
   1. Patient navigator services or programs;
   2. Education and community outreach;
   3. Patient-friendly technical tools to assist patients in identifying available trials;
   4. Counseling services for trial participants;
   5. Well-being services for participants, as specified;
   6. Payment of ancillary costs for patients and caregivers incurred during and related to participation to include, but not limited to, airfare, lodging, car rentals, meals, and dependent child care; and,
   7. Research on the effectiveness of these and other measures to increase patient access to trials.
5. Requires a program administrator to require grantees to submit any reports it deems necessary to ensure the appropriate use of funds. Allows the UC to require the Board to submit reports pertaining to CCTP and Board activities to the UC Regents, including, but not limited to, accounting of funds collected and expended, an evaluation of the CCTP, and recommendations regarding the CCTP.
6. Encourages the Board, when determining grant recipients, to grant special consideration to public and nonprofit applicants that provide patient services related to trials that address health disparities or to applicants that possess two or more years’ experience in the improvement of enrollment, retention, or participation in trial participation with an emphasis on underserved populations.
7. Requests the UC to publicize to National Cancer Institute-Designated Cancer Centers, community organizations, hospitals, hospital associations, industry, health care foundations, and government agencies the opportunity to submit nominations for Board membership to the president of the UC. Requests the UC to publicize the availability of grants made available through the CCTP to the entities specified in 3) above.
8. Allows the UC to participate in the CCTP as the administrator, a beneficiary, or both, and allows the UC to pursue any federal, state, or internal approvals, authorizations, or advice it deems necessary to the UC’s participation. Allows the UC to decline to establish or participate in, and to terminate, the CCTP, as specified.
9. Allows a program administrator to directly or through a UC-affiliated foundation solicit funds from business, industry, foundations, research organizations, federal government agencies, individuals, and other private sources for the purpose of administering the CCTP and awarding grants to increase patient access to trials, consistent with guidelines developed by the Board.

Comments

1. Author’s statement. According to the author, this bill will help remedy the problem of low participation, especially for underrepresented communities, in trials by creating a grant program administered by the UC aimed at breaking down barriers to trial participation. The opportunity to assess and evaluate innovative treatments with participation from women and underrepresented individuals allows researchers to properly test the effects of medication resulting in the opportunity to develop robust treatments that meet the varying genetic make-up of women and men of diverse racial/ethnic groups. Unfortunately, there is currently no support for patients who want to access trials. The clinicaltrials.gov Web site is inadequate and not user friendly. Patients have found difficulty in navigating the Web site and are unable to find an appropriate trial that is suited for them and their disease state. Some of the barriers to patient participation in trials include the following: lack of awareness of the available trials, mistrust of research and the medical system, loss of income, transportation, and lodging costs. This bill will create the CCTP, which will grant money to nonprofits and research institutes focused on breaking down the barriers to trial participation.
2. Clinical trails. According to the National Cancer Institute, the largest sponsor of cancer clinical trials at 3,000 sites, over 30,000 patients are enrolled in trials annually. It is estimated that only about 3-5% of the 10.1 million adults with cancer in the U.S. participate in trials, however. A 2011 study published in the journal Annals of Surgery, based on data from the California Cancer Registry, found that less than one percent of cancer patients in California enroll in trials. Black patients, those older than 65, those with early stage cancer or with gastrointestinal or lung cancers were less likely to enroll than average. In 2004, the SELECT prostate cancer prevention trial completed recruiting over 35,000 men of whom 21% were minorities. According to a 2014 study in the journal Cancer, less than 5% of trial participants are non-white and less than 2% of clinical cancer research studies focus on non-white ethnic or racial groups.

Trials are a critical step in the discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. Without adequate representation of these populations in trials, researchers cannot learn about potential difference among groups and cannot ensure the generalization of results. In addition, participation in trials increases access to state-of-the-art cancer care, a critical survival factor in many minority and underrepresented populations that suffer disproportionately from cancer.

1. Issues with trial participation. According to a document published by the Society for Women’s Health Research and United States Food and Drug Administration (FDA) Office of Women’s Health, “Dialogues on Diversifying Clinical Trials,” the most important diseases that disproportionately affect ethnic minorities include type 2 diabetes, cardiovascular disease, stroke, infectious diseases (HIV/AIDS, STDs), and different types of cancer (colon, prostate, cervix, and lung). Many racial health disparities stem from lack of access to quality health care and proper health awareness. Unfortunately this means that incidence of disease does not always match trial populations. For example, African Americans represent 12% of the U.S. population but only 5% of trial participants. Hispanics make up 16% of the population but only 1% of trial participants. Sex distribution in cardiovascular device trials is 67% male. According to the American Cancer Society Cancer Action Network, only approximately 3% of adults diagnosed with cancer participate in trials, and the participation rate is lower for people who are racial and ethnic minorities, elderly, low-income, and live in rural areas.

The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified minority lack of disease education as a major barrier to recruitment. Other significant barriers to diversify enrollment, as reported by investigators and coordinators, are insurance status, patient inconvenience costs, availability of transportation, distance to the study site, and patient and family concerns about risk. However, race, age, and sex have been shown to play more significant roles in trial participation compared to proximity to trial location.

Prior Legislation

AB 1060 (Bonilla of 2015), was similar to this bill. AB 1060 was vetoed by Governor Brown who stated that numerous private organizations already perform this fundraising function, and while he supports eliminating barriers to take part in trials, he was hesitant to place this new burden on the Health and Human Services Agency (HHS) which is managing a huge expansion of our health care system.

AB 2038 (Alquist, Chapter 250, Statutes of 2000), enacted the Inclusion of Women and Minorities in Clinical Research Act to require any public, private or nonprofit agency conducting clinical research using state funds to ensure that women, including those over 40, and minority groups are included as research subjects. Requires that institutions conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee:

1. Start-up: Unknown one-time General Fund cost pressure for the UC to provide oversight and administration of the CCTP related to initial start-up activities. These costs are required to be reimbursed by moneys donated to the fund (federal or private funds) prior to awarding grants, thereby offsetting the use of state funds. This bill also provides that if the UC determines at any time that the moneys in the fund are insufficient to establish or sustain the CCTP, it may be terminated.
2. Unknown federal or private funds to administer the CCTP and award grants. In order to have a viable Program and offer services as described in this bill, UC indicates that funding would likely need to be in the millions. The scope of the CCTP, including the number of grantees, grant amounts, and administrative support to operate the CCTP, would depend upon future donations.

SUPPORT: (Verified 8/12/16)

Lazarex Cancer Foundation (source)

Association of California Healthcare Districts

Association of Northern California Oncologists

Business & Professional Women of Nevada County

California Academy of PAs

California Chronic Care Coalition

California Immigrant Policy Center

California Pharmacists Association

City of Hope National Medical Center

Community Health Partnership

Health Access California

Medical Oncology Association of Southern California

Pharmaceutical Researchers and Manufacturers of America

Susan G. Komen California Collaborative

University of California

University of Southern California

OPPOSITION: (Verified 8/12/16)

None received

ARGUMENTS IN SUPPORT: Supporters argue that currently only 3% of eligible cancer patients participate in trials, and of those patients only 5% are from underrepresented communities, including African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians. Supporters state that this bill allows researchers to properly evaluate the effects of new therapies and develop more robust treatments designed to meet the varying genetic make-up of women, men, and diverse racial/ethnic groups. Supporters further state that funds from the grants will help cover expenses stemming from trial participation, patient navigation, education and community outreach, and implementing patient-friendly tools to assist them in identifying available trials.

ASSEMBLY FLOOR: 80-0, 6/1/16

AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon

Prepared by: Reyes Diaz / HEALTH / (916) 651-4111

8/15/16 19:47:25

**** END ****

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 1823 (Bonilla) - California Cancer Clinical Trials Program

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

This bill requests the University of California (UC) to establish a board to solicit and receive funds from federal or private sources for the California Cancer Clinical Program (Program) to provide grants to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities.

Fiscal Impact:

• Start-up: Unknown one-time General Fund cost pressure for the UC to provide oversight and administration of the Program related to initial start-up activities. These costs are required to be reimbursed by moneys donated to the fund (federal or private funds) prior to awarding grants, thereby offsetting the use of state funds. This bill also provides that if the UC determines at any time that the moneys in the fund are insufficient to establish or sustain the Program, it may be terminated.
• Unknown federal or private funds to administer the Program and award grants. In order to have a viable Program and offer services as described in this bill, UC indicates that funding would likely need to be in the millions. The scope of the Program, including the number of grantees, grant amounts, and administrative support to operate the Program would depend upon future donations.

Background:

Clinical trials are conducted by pharmaceutical companies seeking approval to market new drugs or existing drugs for additional conditions. In addition, the federal government provides financial support for clinical trials designed to study medical effectiveness or other characteristics of new or existing drugs.

In recent years, concerns have been raised that participants in clinical trials tend not to reflect the larger society, which may bias the results of those trials. Research findings indicate that participants in clinical trials are more likely to be male and to be Caucasian than the general population. Clinical trials tend to be conducted at academic medical centers, often requiring patients to receive their care from a new doctor participating in the trial and often requiring substantial paperwork for patients to enroll. These factors and others have tended to limit participation in clinical trials.

According to the author, barriers to participation include a lack of awareness, mistrust of research and the medical system, loss of income, and transportation and lodging costs. These ancillary costs of participation fall onto the clinical trial participant who may be unable to pay, and therefore unable to enroll in the trial. The intent of this bill is to assist patients in in paying for the ancillary costs associated with participation in these trials.

Proposed Law:

This bill requests the UC to establish a board to solicit and receive funds from federal or private sources for the California Cancer Clinical Program (Program) to provide grants to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities.

Key provisions of the bill include:

• Prior to establishing the Program, the UC may pursue any federal, state, or internal approvals, authorizations, or advice it deems necessary.
• The UC is authorized to use its own state funds for oversight and administration of the Program relating to the initial start-up costs only.
• Any resources provided by the UC to establish and operate the Program are required to be reimbursed from moneys donated in the fund prior to distribution of any grants.
• Only federal or private funds may be used to administer the Program.
• Funds may be provided to research institutions and hospitals that conduct eligible cancer clinical trials and nonprofit organizations, as specified.
• Funds may be used for a number of activities, including but not limited to, technical assistance tools to assist patients in identifying available clinical trials, and payment of ancillary costs related to participation in the clinical trial, such as airfare, lodging, child care, and meals.
• If the UC determines at any time that the moneys in the fund are insufficient to establish or sustain the Program, the UC may terminate the Program.
• Similarly, if the fund does not receive at least $500,000 by January 1, 2021 or if it is determined that the administrative support allocation allowed by this bill is insufficient, the Program administrator may elect to dissolve the program.

Related Legislation:

AB 1060 (Bonilla, 2015) proposed establishment of the Cancer Clinical Trials Foundation in the Health and Human Services Agency to administer a grant program substantively similar to that proposed by this bill. AB 1060 was vetoed by the Governor whose message read, in part: "Numerous private organizations already perform this fundraising function. While I support eliminating barriers to take part in clinical trials, I am hesitant to place this new burden on the Health and Human Services Agency which is managing a huge expansion of our health care system.” This bill establishes the program in the UC instead of within a state agency.

Staff Comments:

According to the UC, in order to operate this Program, it must first receive approval from the federal Office of Inspector General. Once approval is received, the UC can receive donations, of which at least $500,000 is required to begin providing grants to increase patient access to eligible cancer clinical trials. According to the UC, this bill outlines the structure of the program that would meet federal approval.

The UC has already expended state funds for purposes of gaining permission from federal regulators and engaging in other administrative activities to establish the Program. This bill specifies that any resources provided by the UC to establish and operate the Program are required to be reimbursed from moneys donated in the fund prior to distribution of any grants. The ongoing operation of the Program is intended to be supported entirely by private and federal funds.

-- END --

SENATE COMMITTEE ON EDUCATION

Senator Carol Liu, Chair

2015 - 2016 Regular

Bill No:

Subject:

SUMMARY

This bill requests the University of California (UC) to establish a board representing institutions and individuals performing, participating in and supporting eligible cancer clinical trials in California to solicit and receive funds from federal or private sources for the California Cancer Clinical Trials Program, as specified, to provide grants to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities, as specified.

BACKGROUND

The California Constitution establishes the UC, a public trust to be administered by the Regents of the UC and grants the Regents full powers of organization and government, subject only to such legislative control as may be necessary to insure security of its funds, compliance with the terms of its endowments, statutory requirements around competitive bidding and contracts, sales of property and the purchase of materials, goods and services. (Article IX, Section (9)(a) of the California Constitution)

ANALYSIS

This bill establishes the California Cancer Clinical Trials Program. It:

1. Requests the UC to:

• 1. Establish or designate an institute or office with the university to administer the program.
  2. Establish the Board of Trustees of the California Cancer Clinical Trials Program, as specified, to represent institutions and individuals performing, participating in and supporting eligible cancer clinical trials in California.
  3. Publicize the opportunity to submit nomination for board membership.
  4. Publicize the availability of grants that are available through the Program to organizations, as specified.

1. Establishes requirements for the board of the program. It:
   1. Requires that appointees to the board have an interest ability and desire to solicit funds for purpose of increasing and diversifying access to clinical trials.
   2. Requires that board members serve without compensation but be reimbursed for expenses, as specified.
2. Provides for the use of funds for administrative costs by authorizing adjustment of these costs based on the size of the program and funds received and caps the amount allowed for these costs at 20 percent of funds received cover the costs of administration.
3. Authorizes the University of California (UC) to:
   1. Participate as the program administrator, a beneficiary, or both.
   2. Pursue any approvals, authorizations, or advice it deems necessary prior to establishing the program.
   3. Decline to establish or participate in the program.
   4. Terminate the program if it is determined not viable.
4. Authorizes the program administrator to solicit funds, as specified, for the purposes of program administration or awarding grant awards, limits funds for administration to those received from federal or private sources and authorizes the UC to use state source funds for administration and oversight of the program, provided the UC is reimbursed from these sources, and makes implementation of the program contingent upon the receipt of at least $500,000 in funding for this purpose.
5. Requires reimbursement for any resources allocated by the UC for purposes of the program prior to the distribution of any grants.
6. Requires the board to determine criteria to award and administer grants, outlines those entities authorized to be granted awards, encourages consideration of groups that meet specified criteria and outlines the uses of grant awards.
7. Authorizes the program administrator to require reporting by grantees, as specified.
8. Authorizes the UC to terminate the program if it determines funds are insufficient to establish/sustain it, authorizes the program administrator to dissolve the program if $500,000 is not received by January 1, 2021, or if the administrative cap of 20 percent is determined to be inadequate.
9. Requires that money remaining in the fund after payment of expenses be allocated to an organization that meets the qualifications of a grant recipient as outlined in the bill.
10. Clarifies that nothing in the bill’s provisions precludes the UC from establishing or operating other similar programs under specified federal regulations.

STAFF COMMENTS

1. Need for the bill. According to the author, this bill seeks to remedy the problem of low patient participation in FDA-approved cancer clinical trials. More importantly, it is an effort to address the disproportionately low number of patients from underrepresented communities including African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians. The author contends that nationwide, only 3 percent of eligible cancer patients participate in clinical trials and of those, only 5 percent are from these underrepresented communities. According to the author, barriers to participation include a lack of awareness, mistrust of research and the medical system, loss of income, and transportation and lodging costs. These ancillary costs of participation fall onto the clinical trial participant who may be unable to pay, and therefore unable to enroll in the trial.

This bill proposes to address this issue by creating a privately funded grant program through the University of California (UC) to assist patients in paying for the ancillary costs associated with participation in these trials.

1. Impact on UC and state funds? This bill requires that funds for program administration and grant awards come from federal and private sources. It also authorizes the UC to use state source funds for administration and oversight of the program, provided the UC is reimbursed from federal or private sources. According to the author, the UC has already expended state funds for purposes of gaining permission from federal regulators and engaging in other administrative activity to establish the program and these provisions are intended to authorize reimbursement of the funds used for these purposes. There is no intent to use state funds for any ongoing administrative or oversight expenses.

Staff recommends the bill be amended on page 7 lines 19-21 to clarify that these provisions apply to “start-up” oversight and administration costs only.

Staff notes that the bill authorizes up to 20 percent of funds to be used for administrative costs. State funded programs typically authorize up to 5 percent of funding for these costs. The 20 percent figure combines all administrative costs (direct, indirect, and administrative) into one. According to the UC, administrative costs for research programs typically run greater than 20 percent and this cap would be among the lowest in the state for research program administration.

Staff also notes that the UC is authorized to establish, decline to establish or participate, or terminate the program. According to the author, the intent of the bill and for the program is that, once established, the program will operate exclusively on private or federal funds. If the program does not collect sufficient funding to continue operation of the program using private or federal funds, the University is under no obligation to continue program operations. The language in the bill is explicit about the UC’s ability to determine whether or not to establish or terminate the program, to ensure the University will not be compelled to expend state-sourced dollars in operation of the program.

1. Prior legislation. AB 1060 (Bonilla, 2015) proposed establishment of the Cancer Clinical Trials Foundation in the Health and Human Services Agency, to be governed by a board of trustees, to administer a grant program substantively similar to that proposed by this bill. AB 1060 was vetoed in October 2015, by the Governor whose message read, in pertinent part:

"Numerous private organizations already perform this fundraising function. While I support eliminating barriers to take part in clinical trials, I am hesitant to place this new burden on the Health and Human Services Agency which is managing a huge expansion of our health care system.”

SUPPORT

Association of California Healthcare Districts

Susan G. Komen California Collaborative

OPPOSITION

None received.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 1823

SUBJECT: California Cancer Clinical Trials Program

SUMMARY:

Requests the University of California (UC) to create a Board of Trustees of the California Cancer Clinical Trials Program, as specified, which would provide grants to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities, as specified. Allows the UC to decline to establish or participate in, and to terminate, the program, as specified.

Existing law:

1. Establishes the Inclusion of Women and Minorities in Clinical Research Act, which requires a grantee, defined as any qualified public, private, or nonprofit agency or individuals conducting clinical research using state funds in conducting or supporting a project of clinical research, to ensure that women and members of minority groups, as specified, are included as subjects in clinical research projects.
2. Requires health plans and insurers to provide coverage for all routine patient care costs relative to the treatment of an enrollee or insured diagnosed with cancer and accepted in an FDA-approved cancer clinical trial (trial) if the enrollee's treating physician recommends participation in the trial, after determining such participation has a meaningful potential to benefit the enrollee or insured.

This bill:

1. Requests the UC to establish or designate an institute or office within the UC to administer the California Cancer Clinical Trials Program (CCTP) and to establish a Board of Trustees of the CCTP (Board) that:
   1. Consists of at least five members (who serve without compensation, with exception) appointed by the president of the UC to represent institutions and individuals performing, participating in, and supporting eligible trials in California;
   2. Has varying backgrounds to promote the purposes of the CCTP, including the ability and desire to solicit funds for the purpose of increasing and diversifying access to eligible trials;
   3. Is qualified through the experience, expertise, and diversity of its members in the design, implementation, and support of trials, and through studying and addressing socioeconomic, ethnic or racial, regional, and other barriers to participation, and interventions to remove those barriers; and,
   4. Makes efforts to include representatives of a range of public and private research institutions, health care providers, health care foundations, and patient advocacy organizations.
2. Requires the Board to establish the CCTP, upon the program administrator’s receipt of at least $500,000 in funding, to increase patient access to trials in underserved or disadvantaged communities and populations, including women and patients from racial and ethnic minority communities and socioeconomically disadvantaged communities.
3. Requires the Board to determine the criteria to award and administer grants, and allows the Board to award grants to any or all of the following: a) public and private research institutions and hospitals that conduct eligible trials; and b) nonprofit organizations that are exempt from taxation, as specified, and that either specialize in direct patient support for improved trial enrollment and retention, or engage in research on health disparities and their relationship to trial enrollment.
4. Requires grants to be used for activities to increase patient access to trials, including, but not limited to:
   1. Patient navigator services or programs;
   2. Education and community outreach;
   3. Patient-friendly technical tools to assist patients in identifying available trials;
   4. Counseling services for trial participants;
   5. Well-being services for participants, as specified;
   6. Payment of ancillary costs for patients and caregivers incurred during and related to participation to include, but not limited to, airfare, lodging, car rentals, meals, and dependent child care; and,
   7. Research on the effectiveness of these and other measures to increase patient access to trials.
5. Requires the Board to require grantees to submit any reports it deems necessary to ensure the appropriate use of funds. Allows the UC to require the Board to submit reports pertaining to CCTP and Board activities to the UC Regents, including, but not limited to, accounting of funds collected and expended, an evaluation of the CCTP, and recommendations regarding the CCTP.
6. Encourages the Board, when determining grant recipients, to grant special consideration to public and nonprofit applicants that provide patient services related to trials that address health disparities or that possess two or more years’ experience in the improvement of enrollment, retention, or participation in trial participation with an emphasis on underserved populations.
7. Requests the UC to publicize to National Cancer Institute-Designated Cancer Centers, community organizations, hospitals, hospital associations, industry, health care foundations, and government agencies the opportunity to submit nominations for Board membership to the president of the UC. Requests the UC to publicize the availability of grants made available through the CCTP to the entities specified in 3) above.
8. Allows the UC to participate in the CCTP as the administrator, a beneficiary, or both, and allows the UC to pursue any federal, state, or internal approvals, authorizations, or advice it deems necessary to the UC’s participation. Allows the UC to decline to establish or participate in, and to terminate, the CCTP, as specified.
9. Allows the UC to directly or through a UC-affiliated foundation solicit funds from business, industry, foundations, research organizations, federal government agencies, individuals, and other private sources for the purpose of administering the CCTP and awarding grants to increase patient access to trials.

FISCAL EFFECT:

According to the Assembly Appropriations Committee:

1. One-time costs in the low hundreds of thousands to establish the CCTP, develop grant guidelines, and provide initial administrative support (unknown federal and private funds). Any costs to an existing institute or office of the UC would be reimbursed by the fund specified in the bill.
2. Unknown annual cost pressure to award grants and provide administrative support for the new program (unknown federal and private funds). The amount of grant funding the program will be able to award will depend on future donations, as will the level of administrative support needed to award the grants. Given the types of direct services the grants are expected to fund, it is reasonable to assume the level of funding required to make this a meaningful program would be in the millions annually.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, this bill will help remedy the problem of low participation, especially for underrepresented communities, in trials by creating a grant program administered by the UC aimed at breaking down barriers to trial participation. The opportunity to assess and evaluate innovative treatments with participation from women and underrepresented individuals allows researchers to properly test the effects of medication resulting in the opportunity to develop robust treatments that meet the varying genetic make-up of women and men of diverse racial/ethnic groups. Unfortunately, there is currently no support for patients who want to access trials. The clinicaltrials.gov Web site is inadequate and not user friendly. Patients have found difficulty in navigating the Web site and are unable to find an appropriate trial that is suited for them and their disease state. Some of the barriers to patient participation in trials include the following: lack of awareness of the available trials, mistrust of research and the medical system, loss of income, transportation, and lodging costs. This bill will create the CCTP, which will grant money to nonprofits and research institutes focused on breaking down the barriers to trial participation.
2. Background. According to the National Cancer Institute, the largest sponsor of cancer clinical trials at 3,000 sites, over 30,000 patients are enrolled in trials annually. It is estimated that only about 3-5% of the 10.1 million adults with cancer in the U.S. participate in trials, however. A 2011 study published in the journal Annals of Surgery, based on data from the California Cancer Registry, found that less than one percent of cancer patients in California enroll in trials. Black patients, those older than 65, those with early stage cancer or with gastrointestinal or lung cancers were less likely to enroll than average. In 2004, the SELECT prostate cancer prevention trial completed recruiting over 35,000 men of whom 21% were minorities. According to a 2014 study in the journal Cancer, less than 5% of trial participants are non-white and less than 2% of clinical cancer research studies focus on non-white ethnic or racial groups.

Trials are a critical step in the discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. Without adequate representation of these populations in trials, researchers cannot learn about potential difference among groups and cannot ensure the generalization of results. In addition, participation in trials increases access to state-of-the-art cancer care, a critical survival factor in many minority and underrepresented populations that suffer disproportionately from cancer.

1. Issues with trial participation. According to a document published by the Society for Women’s Health Research and United States Food and Drug Administration (FDA) Office of Women’s Health, “Dialogues on Diversifying Clinical Trials,” the most important diseases that disproportionately affect ethnic minorities include type 2 diabetes, cardiovascular disease, stroke, infectious diseases (HIV/AIDS, STDs), and different types of cancer (colon, prostate, cervix, and lung). Many racial health disparities stem from lack of access to quality health care and proper health awareness. Unfortunately this means that incidence of disease does not always match trial populations. For example, African Americans represent 12% of the U.S. population but only 5% of trial participants. Hispanics make up 16% of the population but only 1% of trial participants. Sex distribution in cardiovascular device trials is 67% male. According to the American Cancer Society Cancer Action Network, only approximately 3% of adults diagnosed with cancer participate in trials, and the participation rate is lower for people who are racial and ethnic minorities, elderly, low-income, and live in rural areas.

The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified minority lack of disease education as a major barrier to recruitment. Other significant barriers to diversify enrollment, as reported by investigators and coordinators, are insurance status, patient inconvenience costs, availability of transportation, distance to the study site, and patient and family concerns about risk. However, race, age, and sex have been shown to play more significant roles in trial participation compared to proximity to trial location.

1. Double referral. If this bill passes out of this committee, it will be referred to the Senate Education Committee.
2. Prior legislation. AB 1060 (Bonilla of 2015), was similar to this bill. AB 1060 was vetoed by Governor Brown who stated that numerous private organizations already perform this fundraising function, and while he supports eliminating barriers to take part in trials, he was hesitant to place this new burden on the Health and Human Services Agency (HHS) which is managing a huge expansion of our health care system.

AB 2038 (Alquist, Chapter 250, Statutes of 2000), enacted the Inclusion of Women and Minorities in Clinical Research Act to require any public, private or nonprofit agency conducting clinical research using state funds to ensure that women, including those over 40, and minority groups are included as research subjects. Requires that institutions conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research.

1. Support. Supporters argue that currently only 3% of eligible cancer patients participate in trials, and of those patients only 5% are from underrepresented communities, including African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians. Supporters state that this bill allows researchers to properly evaluate the effects of new therapies and develop more robust treatments designed to meet the varying genetic make-up of women, men, and diverse racial/ethnic groups. Supporters further state that funds from the grants will help cover expenses stemming from trial participation, patient navigation, education and community outreach, and implementing patient-friendly tools to assist them in identifying available trials.

SUPPORT AND OPPOSITION:

Support: Lazarex Cancer Foundation (sponsor)

Association of California Healthcare Districts

Association of Northern California Oncologists

Business & Professional Women of Nevada County

California Academy of PAs

California Chronic Care Coalition

California Immigrant Policy Center

California Pharmacists Association

City of Hope National Medical Center

Community Health Partnership

Health Access California

Medical Oncology Association of Southern California

Pharmaceutical Researchers and Manufacturers of America

Susan G. Komen California Collaborative

University of California

University of Southern California

Oppose: None received

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 1823

Author:(Bonilla)

As Amended Ver:May 27, 2016

Majority vote

SUMMARY: Requests the University of California (UC) establish and designate an institute or office with the authority to solicit and receive funds from business, industry, foundations, and other private and federal sources for the purpose of administering the Cancer Clinical Trials Program (the program) to increase patient access to cancer clinical trials. Establishes a five-member board to administer the program. Requires the program, on receipt of funds totaling $500,000, to establish the Cancer Clinical Trials Grant Program (Grant Program) to increase patient access to cancer clinical trials in underserved or disadvantaged communities and populations. Limits administrative expenses to 20% of funds raised. Allows UC to discontinue the program for various reasons.

FISCAL EFFECT: According to the Assembly Appropriations Committee:

1. One-time costs in the low hundreds of thousands to establish the program, develop grant guidelines, and provide initial administrative support (unknown federal and private funds). Any costs to an existing institute or office of the UC would be reimbursed by the fund specified in the bill.
2. Unknown annual cost pressure to award grants and provide administrative support for the new program (unknown federal and private funds). The amount of grant funding the program will be able to award will depend on future donations, as will the level of administrative support needed to award the grants. Given the types of direct services the grants are expected to fund, it is reasonable to assume the level of funding required to make this a meaningful program would be in the millions annually.

COMMENTS: The author states that this bill seeks to remedy the problem of low patient participation in the federal Food and Drug Administration (FDA)-approved cancer clinical trials. More importantly, there are a disproportionately low number of patients in underrepresented communities including African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians. The author asserts this problem will be addressed by creating a privately funded state grant program to help patients pay for the ancillary costs associated with participation in these trials. Some of the barriers to patient participation in clinical trials include the following: lack of awareness of the available clinical trials, mistrust of research and the medical system, and loss of income. Clinical trials do not pay these ancillary costs associated with participation in a clinical trial such as transportation, hotel stays, and companion traveling expenses. The costs fall onto the clinical trial participant who may be unable to pay and therefore, unable to enroll in the trial.

According to a 2011 report titled "Successful Strategies for Engaging Women and Minorities in Clinical Trials," the National Institutes of Health (NIH) funded studies have specific diversity requirements, but aside from FDA recommendations, there are no regulations currently in place that require industry sponsors to include women and minorities in their trials. Diversity is not a natural priority for industry, where decisions often are made by market attractiveness and potential profit.

According to the California Immigrant Policy Center, a supporter of this bill, the lack of participation in clinical trials by minority groups hinders the ability to develop robust treatments that address the varying genetic make-up of women, men, and diverse racial/ethnic groups. The opportunity to assess and evaluate those innovative treatments with the participation of women and underrepresented minorities allows researchers to properly evaluate the true effects of new therapies. Health Access California (HAC) states that over twenty years after Congress mandated that research funded by the NIH include minorities, little progress has been made to increase participation among people of color. According to HAC, this bill addresses some of the barriers to clinical trial participation by creating the Program.

The University of Southern California supports this bill if it were amended to provide that, at a minimum, one of the five board members should be from the National Cancer Institute designated comprehensive cancer centers. There is no known opposition to this bill.

Analysis Prepared by: John Gilman / HEALTH / (916) 319-2097 FN: 0003279

Date of Hearing: April 27, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 1823

Author:(Bonilla) – As Amended Ver:April 12, 2016

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill requests the University of California (UC) establish and designate a nonprofit public benefit corporation with the authority to solicit and receive funds from business, industry, foundations, and other private and public sources for the purpose of administering the Cancer Clinical Trials Program (the program) to increase patient access to cancer clinical trials. Specifically, this bill:

1. Allows the program administrator to solicit and receive funds from business, industry, foundations, research organizations, government agencies, individuals, and other private and public sources, to be deposited in a fund established by the program administrator for these purposes.
2. Requires that the UC be reimbursed from the fund for any money allocated by the UC to establish and operate the program.
3. Requires a board, upon receipt of $500,000 funding, to establish the program to increase patient access to cancer clinical trials in underserved or disadvantaged communities and populations, including among women and patients from racial and ethnic minority communities.
4. Requires the board to determine the criteria to award grants, and authorize grants to be awarded to either research institutions or nonprofits.
5. Requires grants to be used for activities to increase patient access to cancer clinical trials, including, but not limited to: patient navigator services or programs; education and community outreach; translation and interpretation services of clinical trial information; patient-friendly technical tools to assist patients in identifying available clinical trials; payment of ancillary costs for patients and caregivers.
6. Authorizes the UC to terminate the program if it determines that moneys in the fund are insufficient to establish or sustain the program. Specifies that all moneys in the fund (after repayment of expenses) must be distributed to appropriate organizations before such dissolution.
   
7. Requires that if the fund has not received $500,000 by January 1, 2021, then all moneys (after repayment of startup expenses) shall be returned to the donors on a pro rata basis.

FISCAL EFFECT:

1. One-time costs in the range of $500,000 to establish the nonprofit foundation, develop grant guidelines, provide initial administrative support to the foundation, and begin the program (GF or other unknown public and private funds). Any costs to UC would be reimbursed by the fund specified in the bill.
2. Unknown annual cost pressure to award grants and provide administrative support to the new foundation (GF or other unknown public and private funds). The amount of grant funding the foundation will be able to award will depend on future donations, as will the level of administrative support needed to award the grants and manage the foundation. Given the types of direct services that the grants are expected to fund, it is reasonable to assume the level of funding required to make this a meaningful program would be in the millions annually.

COMMENTS:

1. Purpose. This bill is intended to improve the diversity of patients participating in FDA-approved cancer clinical trials. The author asserts underrepresentation of certain ethnic and socioeconomic groups will be addressed by creating a privately funded state grant program to help patients pay for the ancillary costs associated with participation in these trials. The bill is supported by oncologists, the California Chronic Care Coalition, Health Access California, and other groups, and has no opposition.
2. Background. Clinical trials are a critical step in the discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic minorities, older adults, rural residents, and individuals of lower socioeconomic status are underrepresented among participants in cancer-related trials. Without adequate representation of these populations in clinical trials, researchers cannot learn about potential difference among groups and cannot ensure the generalization of results. In addition, participation in clinical trials increases access to state-of-the-art cancer care.

Barriers to participation include lack of awareness, language/linguistic differences, mistrust, practical obstacles, public misconception, and physician lack of awareness.

1. Prior legislation. AB 1060 (Bonilla) of 2015, was similar to this bill, but housed the program within the California Health and Human Services Agency (CHHSA). It was vetoed by Governor Brown, stating "[n]umerous private organizations already perform this fundraising function. While I support eliminating barriers to take part in clinical trials, I am hesitant to place this new burden on the [CHHSA] which is managing a huge expansion of our health care system." This bill establishes the program in the UC instead of within a state agency.
2. Staff Comments. It appears the intent of the bill is that the program be privately funded through donations. The author may wish to clarify that the program is not envisioned to be funded by the state.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 19, 2016

ASSEMBLY COMMITTEE ON HIGHER EDUCATION

Jose Medina, Chair

ABPCA Bill Id:AB 1823 (

Author:Bonilla) – As Amended Ver:April 12, 2016

[Note: This bill was heard by the Assembly Health Committee on March 15, 2016, and approved by a vote of 17-0.]

SUBJECT: California Cancer Clinical Trials Program

SUMMARY: Requests the University of California (UC) establish and designate a nonprofit public benefit corporation to solicit and receive funds from business, industry, foundations, and other sources for the Cancer Clinical Trials Program (Program) to increase patient access to clinical trials. Specifically, this bill:

1. Finds and declares all of the following:
   1. According to the 2016 report of the Public Policy Institute of California entitled California’s Future: Health Care, significant health disparities exist among socioeconomic, racial, ethnic, and regional groups in California. African Americans and persons with a high school education or less have significantly lower life expectancies than other groups of people, and individuals in some regions of the state or in particular communities face other significant health obstacles.
   2. The ability to translate medical findings from research to practice relies largely on having robust patient participation and a diverse participation pool. A low participation rate or a homogenous participant group prevents segments of the population from benefiting from advances achieved through clinical research and creates uncertainties over the applicability of research findings. Diverse patient participation in a clinical trial depends, in part, on whether a participant can afford ancillary costs like transportation, child care, or lodging during the course of his or her participation. A national study in 2015 found that patient households making less than $50,000 annually were almost 30 percent less likely to participate in clinical trials. This disparity threatens one of the most basic ethical underpinnings of clinical research, the requirement that the benefits of research be made available equitably among all eligible individuals.
   3. California is home to the following 10 National Cancer Institute-Designated Cancer Centers that perform cancer clinical trials research: University of California, Irvine, Chao Family Comprehensive Cancer Center; City of Hope Comprehensive Cancer Center; University of California, Los Angeles, Jonsson Comprehensive Cancer Center; Salk Institute Cancer Center; Sanford Burnham Prebys Medical Discovery Institute; Stanford Cancer Institute; University of California, Davis, Comprehensive Cancer Center; University of California, San Diego, Moores Cancer Center; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center; University of Southern California, Norris Comprehensive Cancer Center.
   4. Cancer is the cause of almost one in four deaths in California. It is the second leading cause of death for Californians and the primary cause of death among Californian Asian/Pacific Islanders. A Californian will be diagnosed with cancer approximately every four minutes, and every ten minutes a Californian will die of cancer. African American Californians in particular face disproportionally higher rates of cancer incidence and mortality compared to other races and ethnicities.
   5. Addressing barriers faced by medically underserved and underrepresented individuals in cancer and other clinical trials and improving access to survivorship resources and services through partnerships with hospitals, regional and community cancer centers, and nonprofit organizations are some of the strategies recommended by the California Dialogue on Cancer, established in 2002 by California’s Comprehensive Cancer Control Program to reduce the burden of cancer in California.
   6. According to the National Cancer Institute Cancer Clinical Trials Resource Guide, some of the barriers preventing individuals with cancer or at high risk of developing cancer from participating in clinical trials are direct and indirect financial and personal costs, including travel and child care expenses.
   7. It is the finding of the Legislature that some corporations, individuals, public and private foundations, and other stakeholders are hesitant to contribute to, or accept funds from, programs that are organized to alleviate financial burdens, and that there are disincentives faced by patients who wish to participate in clinical trials and their caregivers.
   8. It is the intent of the Legislature to enact legislation that would establish a program to authorize business, industry, public and private foundations, individuals, and other stakeholders to donate to the program described in this act, as well as to other nonprofit corporations and public charities that specialize in the enrollment, retention, and increased participation of patients in cancer clinical trials.
   9. It is the intent of the Legislature to enact legislation that would establish a program to better enable donors willing to assist clinical research participants from communities that have documented low levels of access to health services or participation in clinical trials, face financial barriers to participation in clinical trials, or have been identified as priorities for health services, to participate in clinical trials by supporting ancillary costs to boost participation rates among the research participant populations, ensure these trials are widely accessible, improve the development of therapies, and enhance innovation.
2. Requests UC to do all of the following:
   1. Establish or designate an institute or office within the university to administer the program.
   2. Establish the board to consist of at least five members, appointed by the UC president to represent institutions and individuals performing, participating in, and supporting eligible cancer clinical trials in California. Requires the members of the board to have, among other requirements, varying backgrounds to promote the purpose of the Program.
3. Provides that, prior to establishing the board, UC may pursue any federal, state, or international approvals, authorizations or advice necessary for participation in the Program. Provides that the board may use no more than 20% of funds for administrative costs of the Program.
4. Provides that the board may solicit and receive funds from public and private sources and that money expended by UC to establish and operate the Program shall be reimbursed from donated moneys. Provides that UC may terminate the Program if it is determined unviable.
5. Provides that upon receipt of at least $500,000 the board shall establish the Program to provide grants to any or all of the following:
   1. Public and private research institutions and hospitals that conduct eligible cancer clinical trials.
   2. Nonprofit organizations that specialize in direct patient support for improved clinical trial enrollment and retention or engage in research on health disparities and their relationship to clinical trial enrollment.
6. Provides that grants awarded shall be used for activities to increase patient access to eligible cancer clinical trials, including, but not limited to, any of the following:
   1. Patient navigator services or programs;
   2. Education and community outreach;
   3. Patient-friendly technical tools to assist patients in identifying available clinical trials;
   4. Counseling services for clinical trial participants;
   5. Well-being services for clinical trial participants, including, but not limited to, physical therapy, pain management, stress management, and nutrition management;
   6. Provide payments for patients and caregivers may include costs related to participation in the trial, including airfare, lodging, meals, transportation, etc; and,
   7. Research on the effectiveness of these and other measures to increase patient access to clinical trials.
7. Provides that when determining program grant recipients the board is encouraged to grant special consideration to public or nonprofit applicants that provide patient services related to cancer clinical trials that address health disparities or that possess two or more years’ experience in the improvement of enrollment, retention, or participation in cancer clinical trial participation with an emphasis on underserved populations.
8. Provides that the board shall require grantees to submit any reports it deems necessary to ensure the appropriate use of funds consistent with the purposes of this part and the terms of any grant awards.
9. Provides that UC may require the board to submit reports, as specified, pertaining to the board’s activities to the UC Regents.
10. Provides that if UC determines at any time that the moneys in the fund are insufficient to establish or sustain the program, UC may terminate the program; all moneys in the fund remaining after expenses are paid shall, prior to dissolution, be allocated to one or more grant organizations.
11. Provides that if the fund does not receive $500,000 or more by January 1, 2021, or, if at any time, the board determines that the 20% limit on administrative costs is inadequate to support the cost of administering the Program, moneys remaining after the repayment shall be returned to the donors on a pro rata basis.

EXISTING LAW: Establishes UC as a public trust and confers the full powers of the UC upon the UC Regents. The Constitution establishes that the UC is subject to legislative control only to the degree necessary to ensure the security of its funds and compliance with the terms of its endowments. Judicial decisions have held that there are three additional areas in which there may be limited legislative intrusion into university operations: authority over the appropriation of state moneys; exercise of the general police power to provide for the public health, safety and welfare; and, legislation on matters of general statewide concern not involving internal university affairs. (Constitution of California, Article IX, Section 9)

FISCAL EFFECT: Unknown.

COMMENTS: Purpose of this bill. According to the author, this bill seeks to remedy the problem of low patient participation in FDA-approved cancer clinical trials. More importantly, there are a disproportionately low number of patients in underrepresented communities including African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians. The author asserts this problem will be addressed by creating a privately funded state grant program to help patients pay for the ancillary costs associated with participation in these trials. Some of the barriers to patient participation in clinical trials include the following: lack of awareness of the available clinical trials, mistrust of research and the medical system, and loss of income. Clinical trials do not pay these ancillary costs associated with participation in a clinical trial such as transportation, hotel stays, and companion traveling expenses. The costs fall onto the clinical trial participant who may be unable to pay and therefore, unable to enroll in the trial.

Background. According to the Assembly Health Committee analysis, the National Cancer Institute notes over 30,000 patients are enrolled in cancer clinical trials annually. It is estimated that only about 3-5% of the 10.1 million adults with cancer in the U.S. participate in cancer trials, however. A 2011 study published in the journal Annals of Surgery, based on data from the California Cancer Registry, found that less than one percent of cancer patients in California enroll in clinical trials.

Black patients, those older than 65, those with early stage cancer or with gastrointestinal or lung cancers were less likely to enroll than average. In 2004, the SELECT prostate cancer prevention trial completed recruiting over 35,000 men of whom 21% were minorities. According to a 2014 study in the journal Cancer, less than 5% of trial participants are non-white and less than 2% of clinical cancer research studies focus on non-white ethnic or racial groups.

Clinical trials are a critical step in the discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. Without adequate representation of these populations in clinical trials, researchers cannot learn about potential differences among groups, and cannot ensure the generalization of results. In addition, participation in clinical trials increases access to state-of-the-art cancer care, a critical survival factor in many minority and underrepresented populations that suffer disproportionately from cancer.

Committee staff notes that, according to information provided by UC, clinical trials conducted by UC generally have higher participation than the national average from underrepresented minority populations. Figures can range in the 13%-16% participation rate.

Previous legislation. AB 1060 (Bonilla) of 2015, was similar to this bill. It was vetoed by Governor Brown, citing, in part, "numerous private organizations already perform this fundraising function. While I support eliminating barriers to take part in clinical trials, I am hesitant to place this new burden on the Health and Human Services Agency which is managing a huge expansion of our health care system. This bill responds to the Governor's veto message by moving administrative responsibility from HHS to the UC."

Requested amendments. The University of Southern California (USC) has expressed concerns on the appointments structure for the Program board. Specifically, USC notes the USC Norris Comprehensive Cancer Center focuses on testing new therapies for cancer, optimizing existing treatments, discovering prevention methods and developing ways to improve quality of life. USC notes the center is one of the nation's 41 comprehensive cancer centers. According to USC, the board appointment structure should be amended to provide more qualifiers to ensure those with sufficient expertise in cancer treatment serve on the board.

REGISTERED SUPPORT / OPPOSITION:

Support

Association of California Healthcare Districts

Association of Northern California Oncologists

California Academy of PA's

California Chronic Care Coalition

California Immigrant Policy Center

City of Hope

Health Access California

Lazarex Cancer Foundation

Pharmaceutical Researchers and Manufacturers of America

Susan G. Komen California Collaborative

University of California

Opposition

None on File

Analysis Prepared by: Laura Metune / HIGHER ED. / (916) 319-3960

Date of Hearing: March 15, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 1823

Author:(Bonilla) – As Introduced Ver:February 8, 2016

SUBJECT: California Cancer Clinical Trials Program.

SUMMARY: Requests the University of California (UC) establish and designate a nonprofit public benefit corporation with the authority to solicit and receive funds from business, industry, foundations, and other private and public sources for the purpose of administering the Cancer Clinical Trials Program (the Program) to increase patient access to cancer clinical trials. Specifically, this bill:

1. Requests that the UC establish a nonprofit public benefit corporation to administer the Program, to be governed by a five member board appointed by the president of the UC.
2. Specifies the following about the members of the board:
   1. Must have an interest in increasing and diversifying access to eligible cancer clinical trials and the ability and desire to solicit funds for the purpose of increasing and diversifying access to clinical trials; and,
   2. Must serve without compensation, except for reimbursement for any actual, necessary, and reasonable expenses incurred in connection with duties as a board member.
3. Allows the UC to participate in the Program as the program administrator, a beneficiary, or both and permits the UC to decline to establish or participate in the Program.
4. Authorizes the UC, prior to establishing the board, to pursue any federal, state, or internal processes it deems necessary to participate in the program.
5. Allows the program administrator to solicit and receive funds from business, industry, foundations, research organizations, government agencies, individuals, and other private and public sources.
6. Requires that the UC be reimbursed from the fund for any money allocated by the UC to establish and operate the Program.
7. Requires the board, upon receipt of $500,000 funding for the Program, to establish the Cancer Clinical Trials Grant Program (Grant Program) to increase patient access to cancer clinical trials in underserved or disadvantaged communities and populations, including among women and patients from racial and ethnic minority communities.
8. Requires the board to determine the criteria to award grants, and authorize grants to be awarded to either:
   1. Public and private research institutions and hospitals that conduct cancer clinical trials approved by the U.S. Food and Drug Administration (FDA); and,
   2. Nonprofit organizations that specialize in direct patient support for improved clinical trial enrollment and retention, or engage in research on health disparities.
9. Requires grants to be used for activities to increase patient access to cancer clinical trials, including, but not limited to, any of the following:
   1. Patient navigator services or programs;
   2. Education and community outreach;
   3. Patient-friendly technical tools to assist patients in identifying available clinical trials;
   4. Translation and interpretation services of clinical trial information;
   5. Counseling services for clinical trial participants;
   6. Well-being services for clinical trial participants, including, but not limited to, physical therapy, pain management, stress management, and nutrition management;
   7. Payment of ancillary costs for patients and caregivers, including, but not limited to: airfare, lodging, rental cars, fuel, local transportation via bus, train, or other public transportation, meals, and child care costs only during the clinical trial; and,
   8. Research on the effectiveness of these and other measures to increase patient access to clinical trials.
10. Requires grantees to report to the board any reports deemed necessary to ensure the appropriate use of funds.
    
11. Allows the UC to require the board to submit reports to the Regents of the University of California on information including, but not limited to accounting of funds collected and paid, program evaluation, and program recommendations.
12. Authorizes the UC to terminate the Program if it determines that moneys in the fund are insufficient to establish or sustain the program. Specifies that all moneys in the fund (after repayment of expenses) must be distributed to appropriate organizations before such dissolution.
    
13. Requires that if the fund has not received $500,000 by January 1, 2021, then all moneys (after repayment of startup expenses) shall be returned to the donors.
    
14. Makes findings and declarations and states legislative intent to establish a program to enable willing patients of low to moderate income to participate in cancer clinical trials in order to boost participation rates, ensure these trials are widely accessible, improve the development of cancer therapies, and enhance innovation.
    

EXISTING LAW:

1. Establishes the Inclusion of Women and Minorities in Clinical Research Act, which requires a grantee, defined, as any qualified public, private, or nonprofit agency or individuals conducting clinical research using state funds, in conducting or supporting a project of clinical research to ensure that women of all ages, and members of minority groups are included as subjects in the clinical research projects.
2. Requires health plans and insurers to provide coverage for all routine patient care costs relative to the treatment of an enrollee or insured diagnosed with cancer and accepted in an FDA-approved cancer clinical trial if the enrollee's treating physician, recommends participation in the clinical trial after determining such participation has a meaningful potential to benefit the enrollee or insured.

FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. The author states that this bill seeks to remedy the problem of low patient participation in FDA-approved cancer clinical trials. More importantly, there are a disproportionately low number of patients in underrepresented communities including African Americans, Latinos/Hispanics, Asians and Pacific Islanders, and American Indians. The author asserts this problem will be addressed by creating a privately funded state grant program to help patients pay for the ancillary costs associated with participation in these trials. Some of the barriers to patient participation in clinical trials include the following: lack of awareness of the available clinical trials, mistrust of research and the medical system, and loss of income. Clinical trials do not pay these ancillary costs associated with participation in a clinical trial such as transportation, hotel stays, and companion traveling expenses. The costs fall onto the clinical trial participant who may be unable to pay and therefore, unable to enroll in the trial.
   
2. BACKGROUND. According to the National Cancer Institute, the largest sponsor of cancer clinical trials at 3,000 sites, over 30,000 patients are enrolled in cancer clinical trials annually. It is estimated that only about 3-5% of the 10.1 million adults with cancer in the U.S. participate in cancer trials, however. A 2011 study published in the journal Annals of Surgery, based on data from the California Cancer Registry, found that less than one percent of cancer patients in California enroll in clinical trials.

Black patients, those older than 65, those with early stage cancer or with gastrointestinal or lung cancers were less likely to enroll than average. In 2004, the SELECT prostate cancer prevention trial completed recruiting over 35,000 men of whom 21% were minorities. According to a 2014 study in the journal Cancer, less than 5% of trial participants are non-white and less than 2% of clinical cancer research studies focus on non-white ethnic or racial groups.

Clinical trials are a critical step in the discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. Without adequate representation of these populations in clinical trials, researchers cannot learn about potential difference among groups and cannot ensure the generalization of results. In addition, participation in clinical trials increases access to state-of-the-art cancer care, a critical survival factor in many minority and underrepresent populations that suffer disproportionately from cancer.

1. BARRIERS TO TRIAL PARTICIPATION. The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified a number of reasons that represent major barriers to minority recruitment in clinical trials. There are many different factors that have been attributed, in part, to the very low participation rate of all eligible patients in clinical trials, and the disproportionately low participation rate of minority populations including, but not limited to:
   
   1. Lack of awareness: A national survey of cancer patients found that 85% of respondents were unaware that participating in a clinical trial was a treatment option for them.
      
   2. Language/Linguistic differences: Many U.S. clinical trials require English proficiency for potential participants, automatically excluding those who do not speak the language. Language factors also pose a serious barrier to provider-patient communications and attempts to recruit patients into clinical trials.
      
   3. Mistrust: According to a review conducted by the Agency for Healthcare Research and Quality, mistrust of research and the medical system is a frequently reported barrier to participating in clinical trials.
      
   4. Practical obstacles: Transportation to and from a trial, particularly if it is located in a distant location, can be a barrier for many patients. Individuals with low incomes may find it difficult to take time off from work, find childcare or manage other family responsibilities while participating in a trial.
      
   5. Public misconception: Among patients that are aware of clinical trials, a large percentage choose not to enroll, often due to fear of getting a placebo in place of actual treatment, belief that standard treatment is better than what they would be offered in a clinical trial and fear of being a "guinea pig." In fact, placebos are rarely used in cancer treatment trials, and never in lieu of standard treatment.
      
   6. Physician lack of awareness: Being unaware that clinical trials are available is one of the most common reasons physicians fail to refer patients to trials. Primary care physicians do not have sufficient information on available clinical trials, and often leave the discussion of clinical research to the patient’s oncologist. Yet, many oncologists outside of the academic setting may also not be aware of trials or otherwise choose not to participate in or refer their eligible patients to clinical trials.
2. FEDERAL EFFORTS TO INCREASE WOMEN AND MINORITY PARTICIPATION. The FDA Office of Women’s Health (OWH) was established by congressional mandate to advocate for the participation of women in clinical trials and the analyses of data by sex. OWH supports studies to track the participation of women in clinical trials and collaborates with FDA centers and external partners to understand sex and gender differences in disease prevalence and response to therapy through science and research. The FDA Office of Minority Health is housed within the Office of the Commissioner and is the principal advisor on minority health and health disparities. The office is responsible for coordinating efforts throughout the FDA and has focused its efforts on three key areas: communicating and disseminating agency information to vulnerable populations; increasing participation of diverse health professionals in FDA activities to strengthen its capacity to address health disparities; and, advocating for meaningful participation of minorities in clinical trials as well as the analysis of subpopulation data.

According to a 2011 report titled "Successful Strategies for Engaging Women and Minorities in Clinical Trials," the National Institutes of Health (NIH) funded studies have specific diversity requirements, but aside from FDA recommendations, there are no regulations currently in place that require industry sponsors to include women and minorities in their trials. Diversity is not a natural priority for industry, where decisions often are made by market attractiveness and potential profit.

1. SUPPORT. According to the California Immigrant Policy Center, the lack of participation in clinical trials by minority groups hinders the ability to develop robust treatments that address the varying genetic make-up of women, men, and diverse racial/ethnic groups. The opportunity to assess and evaluate those innovative treatments with the participation of women and underrepresented minorities allows researchers to properly evaluate the true effects of new therapies. Health Access California (HAC) states that over twenty years after Congress mandated that research funded by the NIH include minorities, little progress has been made to increase participation among people of color. According to HAC, this bill addresses some of the barriers to clinical trial participation by creating the Program.
   
2. SUPPORT IF AMENDED. The University of Southern California states that that while it is supportive of the grant model, it has concerns on the appointment structure. As currently drafted, this bill would establish a governing board that consists of five members, who will be appointed by the President of the UC, that represent individuals performing, participating in, and supporting eligible cancer clinical trials in California. At a minimum, one of the five individuals should be from the National Cancer Institute (NCI)-designated comprehensive cancer centers. The NCI-designated centers must meet a breadth and depth of expertise in basic science, translational science and population science while providing direct cancer treatment to its patients.
   
3. PREVIOUS LEGISLATION.
   1. AB 1060 (Bonilla) of 2015, was similar to this bill. It was vetoed by Governor Brown, stating "[n]umerous private organizations already perform this fundraising function. While I support eliminating barriers to take part in clinical trials, I am hesitant to place this new burden on the Health and Human Services Agency (HHS) which is managing a huge expansion of our health care system."
   2. AB 2038 (Alquist), Chapter 250, Statutes of 2000, enacted the Inclusion of Women and Minorities in Clinical Research Act to require any public, private or nonprofit agency conducting clinical research using state funds to ensure that women, including those over 40, and minority groups are included as research subjects. Requires that institutions conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research.
4. DOUBLE REFERRAL. This bill is double referred; upon passage in this committee, this bill will be referred to the Assembly Committee on Higher Education.
5. COMMENTS. This bill is similar to AB 1060, which was vetoed by the Governor last year due to potential burden to HHS. This bill would create the program within the UC, instead of within HHS. The committee may wish to clarify whether the changes in this bill address the concerns raised by the Governor in his veto of AB 1060.
   
   
   
6. TECHNICAL AMENDMENTS.
   1. On page 5, line 25 of the bill, it should be clarified that grants can be awarded to nonprofit organizations that "Engage in research on health disparities and their relationship to clinical trial enrollment."
   2. On page 6, line 30 of the bill, reference to the foundation should be changed to the fund, as such: "If the foundation fund does not receive five hundred…"
      

REGISTERED SUPPORT / OPPOSITION:

Support

Association of Northern California Oncologists

California Academy of PAs

California Chronic Care Coalition

Community Health Partnership

Community Immigrant Policy Center

Health Access California

Medical Oncology Association of Southern California, Inc.

Opposition

None on file.

Analysis Prepared by: Dharia McGrew / HEALTH / (916) 319-2097