BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                    AB 1823


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          CONCURRENCE IN SENATE AMENDMENTS


          AB  
          1823 (Bonilla)


          As Amended  August 19, 2016


          Majority vote


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          |ASSEMBLY:  |80-0  |(June 1, 2016) |SENATE: |39-0  |(August 23,      |
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          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  








                                                                    AB 1823


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          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  








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          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