BILL ANALYSIS                                                                                                                                                                                                    Ó






           ----------------------------------------------------------------- 
          |SENATE RULES COMMITTEE            |                       AB 1060|
          |Office of Senate Floor Analyses   |                              |
          |(916) 651-1520    Fax: (916)      |                              |
          |327-4478                          |                              |
           ----------------------------------------------------------------- 


                                   THIRD READING 


          Bill No:  AB 1060
          Author:   Bonilla (D)
          Amended:  8/31/15 in Senate
          Vote:     21  

           SENATE HEALTH COMMITTEE:  9-0, 7/15/15
           AYES:  Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,  
            Pan, Roth, Wolk

           SENATE APPROPRIATIONS COMMITTEE:  7-0, 8/27/15
           AYES:  Lara, Bates, Beall, Hill, Leyva, Mendoza, Nielsen

           ASSEMBLY FLOOR:  77-0, 5/7/15 (Consent) - See last page for  
            vote

           SUBJECT:   Cancer clinical trials


          SOURCE:    Lazarex Cancer Foundation


          DIGEST:  This bill requires the California Health and Human  
          Services Agency to establish a nonprofit Cancer Clinical Trials  
          Foundation to solicit and receive funds from business, industry,  
          foundations, and other private and public sources for the  
          purpose of administering the Cancer Clinical Trials Grant  
          Program to increase patient access to cancer clinical trials.


          ANALYSIS:   


          Existing law:








                                                                    AB 1060  
                                                                    Page  2



          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 individual,  
            including, but not limited to, colleges, universities,  
            hospitals, laboratories, research institutions, local health  
            departments, voluntary health agencies, health maintenance  
            organizations, corporations, students, fellows, entrepreneurs,  
            and individuals conducting clinical research using state  
            funds, in conducting or supporting a project of clinical  
            research, as defined, to ensure that women of all ages, and  
            members of minority groups, as defined, are included as  
            subjects in the clinical research projects, except under  
            prescribed circumstances. 

          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  
            U.S. Food and Drug Administration (FDA) approved cancer  
            clinical trial, Phase I-IV, 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.
          
          This bill:

          1)Requires the California Health and Human Services Agency  
            (CHHS) to establish a nonprofit public benefit corporation, to  
            be known as the Cancer Clinical Trials Foundation, governed by  
            a five-member board, appointed by the Governor, the Speaker of  
            the Assembly, and the Pro Tempore of the Senate with a  
            four-year term.  

          2)Creates the Cancer Clinical Trials Fund for the administration  
            and support of the program.  Requires moneys in the fund to be  
            appropriated by the Legislature.

          3)Permits the Cancer Clinical Trials Foundation to solicit and  
            receive funds from business, industry, foundations, and other  
            private and public sources for the purpose of administering  
            the Cancer Clinical Trials Grant Program.  Permits  
            applications for federal funds.

          4)Requires the board to use no more than 20% of funds made  







                                                                    AB 1060  
                                                                    Page  3


            available for the Cancer Clinical Trials Grant Program for  
            administrative costs.

          5)Limits CHHS from spending more than $300,000 to establish the  
            foundation and requires the foundation to pay the funds back  
            on or before January 1, 2021.  Prohibits General Fund moneys  
            to be used to operate the foundation.

          6)Requires, upon contribution of at least $500,000, to the  
            foundation, the board to establish the Cancer Clinical Trials  
            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. 

          7)Requires the board to determine the criteria to award grants,  
            and authorize grants to be awarded to either or both, public  
            and private research institutions and hospitals that conduct  
            cancer clinical trials approved by the FDA and nonprofit  
            organizations that specialize in direct patient support for  
            improved clinical trial enrollment and retention, as  
            specified.

          8)Requires the board to report to the Legislature to ensure the  
            appropriate use of the funds.  Requires the report to include  
            accountability measures, including, but not limited to, a  
            description of how the funds were used, an evaluation of the  
            grant program, and recommendations for the program, and to be  
            submitted by January 1, 2020.

          9)Requires the foundation to return moneys to the donors on a  
            pro rata basis, after the repayment required in 3) above, if  
            the foundation does not receive $500,000 or more by January 1,  
            2021.  Sunsets this bill on January 1, 2022.

          Comments
          
          1)Author's statement.  According to the author, access to  
            clinical trials is an important part of our health care  
            system. It allows people to try innovative, alternative  
            treatments when traditional treatments have not been  
            successful and helps to get these new treatments approved for  
            mainstream use.  Unfortunately, we have seen limited access to  
            clinical trials for women and people of color. One of the top  







                                                                    AB 1060  
                                                                    Page  4


            reasons that patients report not participating in clinical  
            trials is economic hardship. There are many costs associated  
            with participating in a clinical trial including  
            transportation costs, hotel costs, and companion traveling  
            expenses. In addition, there are other barriers to trials such  
            as lack of education and awareness of available cancer  
            clinical trials. AB 1060 takes a step to increase access to  
            cancer clinical trials by creating a privately funded grant  
            program to connect patients with the appropriate clinical  
            trial.  

          2)Clinical Trial Patient Challenges.  According to a 2010  
            Workshop Summary of Transforming Clinical Research in the  
            United States, many workshop participants noted that patients  
            often are unaware of the possibility of enrolling in a  
            clinical trial. If they are aware of this opportunity, it is  
            often difficult for them to locate a trial. Patients may  
            reside far from study centers; even the largest multicenter  
            trials can pose geographic challenges for those wishing to  
            participate. Depending on the number of clinic visits required  
            by the study protocol, significant travel and time costs may  
            be associated with participation. In addition, trials designed  
            with narrow eligibility criteria for participation purposely  
            eliminate many patients who might have the disease being  
            studied but are ineligible because of other characteristics  
            (e.g., age, level of disease progression, exposure to certain  
            medicines).  Trials often require patients to temporarily  
            leave the care of their regular doctor and receive services  
            from unfamiliar providers, confronting interruptions in care.  
            If a patient reaches the point of enrolling in a clinical  
            trial, the extensive paperwork associated with the informed  
            consent process can be confusing and burdensome. Informed  
            consent forms are developed to meet legal requirements and can  
            contribute to the confusion patients feel regarding the trial  
            and what it entails. In addition, there is sometimes a  
            mistrust of industry-sponsored trials among the public. These  
            feelings of mistrust can further complicate the already  
            difficult decision about whether to join a trial.


          3)Disparities.  A Cancer Clinical Trial Fact Sheet made possible  
            by an unrestricted educational grant from Genentech, provided  
            by the author, indicates that only about 3-5% of the 10.1  
            million adults with cancer in the U.S. participate in cancer  







                                                                    AB 1060  
                                                                    Page  5


            trials.  This compares to 60% participation rate for children  
            with cancer.  A review of FDA approved drugs from 1995-1999  
            revealed that African Americans, Asian/Pacific Islanders,  
            Hispanics/Latinos and Native Americans collectively  
            represented less than 10% of participants in trials that were  
            testing cancer drugs.  In 2004, the SELECT prostate cancer  
            prevention trial completed recruiting over 35,000 men of whom  
            21% were minorities.  With regard to challenges, the Fact  
            Sheet indicates that 85% of respondents to a national survey  
            were unaware that participating in a clinical trial was a  
            treatment option for them.  According to a review of  
            enrollment decisions for health research studies, racial and  
            ethnic minorities were less likely to be invited to  
            participate in research studies compared with  
            non-Hispanic/Latino whites.

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

          According to the Senate Appropriations Committee:

          1)Anticipated one-time costs of $650,000 to establish the  
            nonprofit foundation, develop grant guidelines, provide  
            initial administrative support to the foundation, and begin  
            the initial fundraising effort before sufficient donations  
            have been received to support the foundation (General Fund).

          2)Unknown annual costs to award grants and provide  
            administrative support to the new foundation (private funds).  
            The amount of grant funding that the foundation will be able  
            to award will depend on future donations from the public as  
            will the level of administrative support needed to award the  
            grants and manage the foundation.


          SUPPORT:   (Verified8/31/15)


          Lazarex Cancer Foundation (source)
          Association of Northern California Oncologists
          Biocom
          California Life Sciences Association
          City of Hope National Medical Center
          Pharmaceutical Researchers and Manufacturers of America







                                                                    AB 1060  
                                                                    Page  6


          Stanford Healthcare
          University of Southern California


          OPPOSITION:   (Verified8/28/15)


          None received


          ARGUMENTS IN SUPPORT:     According to the Lazarex Cancer  
          Foundation this bill seeks to remedy the problem of low patient  
          participation in clinical trials, especially participation by  
          women and underrepresented communities.  Lazarex states that the  
          American Medical Association conducted a study on cancer trial  
          participation and found from 1996 to 2002, of the 75,215  
          patients enrolled in the National Cancer Institute trials for  
          breast, lung, colorectal, and prostate cancers, only 3.1% were  
          Hispanic, 9.2% were black, and 1.9% were Asian/Pacific  
          Islanders, while 85.6% were white.  The lack of diversity  
          impacts researcher's ability to evaluate the effect of new  
          treatments on different populations, and speaks to a lack of  
          access to potentially lifesaving trials for a large portion of  
          the populations.  The Association of Northern California  
          Oncologists Board of Directors writes that clinical trials are  
          an essential component of developing new and innovative  
          treatments for all types of cancer and give vulnerable patients  
          access to new treatment options that would not otherwise be  
          available to them.  This new foundation could raise funds to  
          overcome barriers, helping the entire research process.  The  
          University of Southern California writes that this bill is an  
          innovative approach focused on addressing barriers to patient  
          participation in clinical trials.  Biocom writes that although  
          many companies operating in this space already have established  
          programs to address this issue of clinical trial participation  
          in underrepresented communities, it is hoped that a concerted  
          state effort may reach trial candidates and their physicians  
          more effectively.

          ASSEMBLY FLOOR:  77-0, 5/7/15
          AYES:  Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,  
            Bonilla, Bonta, Brough, Brown, Burke, Calderon, Chang, Chau,  
            Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly,  
            Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina  







                                                                    AB 1060  
                                                                    Page  7


            Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,  
            Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones,  
            Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,  
            Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,  
            Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea,  
            Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Mark  
            Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams,  
            Wood, Atkins
          NO VOTE RECORDED:  Campos, Roger Hernández, Steinorth

          Prepared by:Teri Boughton / HEALTH / 
          8/31/15 19:58:29


                                   ****  END  ****