BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                    AB 1823


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          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,    |                    |








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          |                |     |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.









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          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.  








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          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

















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