BILL ANALYSIS Ó AB 1823 Page 1 ASSEMBLY THIRD READING AB 1823 (Bonilla) As Amended May 27, 2016 Majority vote ------------------------------------------------------------------ |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+----------------------+--------------------| |Health |17-0 |Wood, Maienschein, | | | | |Bonilla, Burke, | | | | |Campos, Dababneh, | | | | |Cooley, Roger | | | | |Hernández, Lackey, | | | | |Nazarian, Olsen, | | | | |Patterson, Rodriguez, | | | | |Santiago, Steinorth, | | | | |Thurmond, Waldron | | | | | | | |----------------+-----+----------------------+--------------------| |Higher |13-0 |Medina, Baker, Bloom, | | |Education | |Chávez, Irwin, | | | | |Jones-Sawyer, Levine, | | | | |Linder, Low, Olsen, | | | | |Santiago, Weber, | | | | |Williams | | | | | | | |----------------+-----+----------------------+--------------------| |Appropriations |20-0 |Gonzalez, Bigelow, | | AB 1823 Page 2 | | |Bloom, Bonilla, | | | | |Bonta, Calderon, | | | | |Chang, Daly, Eggman, | | | | |Gallagher, Eduardo | | | | |Garcia, Roger | | | | |Hernández, Holden, | | | | |Jones, Obernolte, | | | | |Quirk, Santiago, | | | | |Wagner, Weber, Wood | | | | | | | | | | | | ------------------------------------------------------------------ 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. AB 1823 Page 3 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. AB 1823 Page 4 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 AB 1823 Page 5