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 ****