BILL ANALYSIS Ó AB 1823 Page 1 Date of Hearing: March 15, 2016 ASSEMBLY COMMITTEE ON HEALTH Jim Wood, Chair AB 1823 (Bonilla) - As Introduced February 8, 2016 SUBJECT: California Cancer Clinical Trials Program. SUMMARY: Requests the University of California (UC) establish and designate a nonprofit public benefit corporation with the authority to solicit and receive funds from business, industry, foundations, and other private and public sources for the purpose of administering the Cancer Clinical Trials Program (the Program) to increase patient access to cancer clinical trials. Specifically, this bill: 1)Requests that the UC establish a nonprofit public benefit corporation to administer the Program, to be governed by a five member board appointed by the president of the UC. 2)Specifies the following about the members of the board: a) Must have an interest in increasing and diversifying access to eligible cancer clinical trials and the ability and desire to solicit funds for the purpose of increasing and diversifying access to clinical trials; and, AB 1823 Page 2 b) Must serve without compensation, except for reimbursement for any actual, necessary, and reasonable expenses incurred in connection with duties as a board member. 3)Allows the UC to participate in the Program as the program administrator, a beneficiary, or both and permits the UC to decline to establish or participate in the Program. 4)Authorizes the UC, prior to establishing the board, to pursue any federal, state, or internal processes it deems necessary to participate in the program. 5)Allows the program administrator to solicit and receive funds from business, industry, foundations, research organizations, government agencies, individuals, and other private and public sources. 6)Requires that the UC be reimbursed from the fund for any money allocated by the UC to establish and operate the Program. 7)Requires the board, upon receipt of $500,000 funding for the Program, 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, including among women and patients from racial and ethnic minority communities. 8)Requires the board to determine the criteria to award grants, and authorize grants to be awarded to either: AB 1823 Page 3 a) Public and private research institutions and hospitals that conduct cancer clinical trials approved by the U.S. Food and Drug Administration (FDA); and, b) Nonprofit organizations that specialize in direct patient support for improved clinical trial enrollment and retention, or engage in research on health disparities. 9)Requires grants to be used for activities to increase patient access to cancer clinical trials, including, but not limited to, any of the following: a) Patient navigator services or programs; b) Education and community outreach; c) Patient-friendly technical tools to assist patients in identifying available clinical trials; d) Translation and interpretation services of clinical trial information; e) Counseling services for clinical trial participants; f) Well-being services for clinical trial participants, including, but not limited to, physical therapy, pain management, stress management, and nutrition management; g) Payment of ancillary costs for patients and caregivers, including, but not limited to: airfare, lodging, rental cars, fuel, local transportation via bus, train, or other public transportation, meals, and child care costs only during the clinical trial; and, AB 1823 Page 4 h) Research on the effectiveness of these and other measures to increase patient access to clinical trials. 10)Requires grantees to report to the board any reports deemed necessary to ensure the appropriate use of funds. 11)Allows the UC to require the board to submit reports to the Regents of the University of California on information including, but not limited to accounting of funds collected and paid, program evaluation, and program recommendations. 12)Authorizes the UC to terminate the Program if it determines that moneys in the fund are insufficient to establish or sustain the program. Specifies that all moneys in the fund (after repayment of expenses) must be distributed to appropriate organizations before such dissolution. 13)Requires that if the fund has not received $500,000 by January 1, 2021, then all moneys (after repayment of startup expenses) shall be returned to the donors. 14)Makes findings and declarations and states legislative intent to establish a program to enable willing patients of low to moderate income to participate in cancer clinical trials in order to boost participation rates, ensure these trials are widely accessible, improve the development of cancer therapies, and enhance innovation. AB 1823 Page 5 EXISTING LAW: 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 individuals conducting clinical research using state funds, in conducting or supporting a project of clinical research to ensure that women of all ages, and members of minority groups are included as subjects in the clinical research projects. 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 FDA-approved cancer clinical trial 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. FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee. COMMENTS: 1)PURPOSE OF THIS BILL. The author states that this bill seeks to remedy the problem of low patient participation in 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 AB 1823 Page 6 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. 2)BACKGROUND. According to the National Cancer Institute, the largest sponsor of cancer clinical trials at 3,000 sites, over 30,000 patients are enrolled in cancer clinical trials annually. It is estimated that only about 3-5% of the 10.1 million adults with cancer in the U.S. participate in cancer trials, however. A 2011 study published in the journal Annals of Surgery, based on data from the California Cancer Registry, found that less than one percent of cancer patients in California enroll in clinical trials. Black patients, those older than 65, those with early stage cancer or with gastrointestinal or lung cancers were less likely to enroll than average. In 2004, the SELECT prostate cancer prevention trial completed recruiting over 35,000 men of whom 21% were minorities. According to a 2014 study in the journal Cancer, less than 5% of trial participants are non-white and less than 2% of clinical cancer research studies focus on non-white ethnic or racial groups. Clinical trials are a critical step in the discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are AB 1823 Page 7 underrepresented among participants in cancer-related trials. Without adequate representation of these populations in clinical trials, researchers cannot learn about potential difference among groups and cannot ensure the generalization of results. In addition, participation in clinical trials increases access to state-of-the-art cancer care, a critical survival factor in many minority and underrepresent populations that suffer disproportionately from cancer. 3)BARRIERS TO TRIAL PARTICIPATION. The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified a number of reasons that represent major barriers to minority recruitment in clinical trials. There are many different factors that have been attributed, in part, to the very low participation rate of all eligible patients in clinical trials, and the disproportionately low participation rate of minority populations including, but not limited to: a) Lack of awareness: A national survey of cancer patients found that 85% of respondents were unaware that participating in a clinical trial was a treatment option for them. b) Language/Linguistic differences: Many U.S. clinical trials require English proficiency for potential participants, automatically excluding those who do not speak the language. Language factors also pose a serious barrier to provider-patient communications and attempts to recruit patients into clinical trials. c) Mistrust: According to a review conducted by the Agency for Healthcare Research and Quality, mistrust of research and the medical system is a frequently reported barrier to participating in clinical trials. AB 1823 Page 8 d) Practical obstacles: Transportation to and from a trial, particularly if it is located in a distant location, can be a barrier for many patients. Individuals with low incomes may find it difficult to take time off from work, find childcare or manage other family responsibilities while participating in a trial. e) Public misconception: Among patients that are aware of clinical trials, a large percentage choose not to enroll, often due to fear of getting a placebo in place of actual treatment, belief that standard treatment is better than what they would be offered in a clinical trial and fear of being a "guinea pig." In fact, placebos are rarely used in cancer treatment trials, and never in lieu of standard treatment. f) Physician lack of awareness: Being unaware that clinical trials are available is one of the most common reasons physicians fail to refer patients to trials. Primary care physicians do not have sufficient information on available clinical trials, and often leave the discussion of clinical research to the patient's oncologist. Yet, many oncologists outside of the academic setting may also not be aware of trials or otherwise choose not to participate in or refer their eligible patients to clinical trials. 4)FEDERAL EFFORTS TO INCREASE WOMEN AND MINORITY PARTICIPATION. The FDA Office of Women's Health (OWH) was established by congressional mandate to advocate for the participation of women in clinical trials and the analyses of data by sex. OWH supports studies to track the participation of women in clinical trials and collaborates with FDA centers and external AB 1823 Page 9 partners to understand sex and gender differences in disease prevalence and response to therapy through science and research. The FDA Office of Minority Health is housed within the Office of the Commissioner and is the principal advisor on minority health and health disparities. The office is responsible for coordinating efforts throughout the FDA and has focused its efforts on three key areas: communicating and disseminating agency information to vulnerable populations; increasing participation of diverse health professionals in FDA activities to strengthen its capacity to address health disparities; and, advocating for meaningful participation of minorities in clinical trials as well as the analysis of subpopulation data. 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. 5)SUPPORT. According to the California Immigrant Policy Center, 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 AB 1823 Page 10 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. 6)SUPPORT IF AMENDED. The University of Southern California states that that while it is supportive of the grant model, it has concerns on the appointment structure. As currently drafted, this bill would establish a governing board that consists of five members, who will be appointed by the President of the UC, that represent individuals performing, participating in, and supporting eligible cancer clinical trials in California. At a minimum, one of the five individuals should be from the National Cancer Institute (NCI)-designated comprehensive cancer centers. The NCI-designated centers must meet a breadth and depth of expertise in basic science, translational science and population science while providing direct cancer treatment to its patients. 7)PREVIOUS LEGISLATION. a) AB 1060 (Bonilla) of 2015, was similar to this bill. It was vetoed by Governor Brown, stating "[n]umerous private organizations already perform this fundraising function. While I support eliminating barriers to take part in clinical trials, I am hesitant to place this new burden on the Health and Human Services Agency (HHS) which is managing a huge expansion of our health care system." b) AB 2038 (Alquist), Chapter 250, Statutes of 2000, enacted the Inclusion of Women and Minorities in Clinical Research Act to require any public, private or nonprofit agency conducting clinical research using state funds to AB 1823 Page 11 ensure that women, including those over 40, and minority groups are included as research subjects. Requires that institutions conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research. 8)DOUBLE REFERRAL. This bill is double referred; upon passage in this committee, this bill will be referred to the Assembly Committee on Higher Education. 9)COMMENTS. This bill is similar to AB 1060, which was vetoed by the Governor last year due to potential burden to HHS. This bill would create the program within the UC, instead of within HHS. The committee may wish to clarify whether the changes in this bill address the concerns raised by the Governor in his veto of AB 1060. 10)TECHNICAL AMENDMENTS. a) On page 5, line 25 of the bill, it should be clarified that grants can be awarded to nonprofit organizations that "Engage in research on health disparities and their relationship to clinical trial enrollment." b) On page 6, line 30 of the bill, reference to the foundation should be changed to the fund, as such: "If thefoundationfund does not receive five hundred?" REGISTERED SUPPORT / OPPOSITION: AB 1823 Page 12 Support Association of Northern California Oncologists California Academy of PAs California Chronic Care Coalition Community Health Partnership Community Immigrant Policy Center Health Access California Medical Oncology Association of Southern California, Inc. Opposition None on file. AB 1823 Page 13 Analysis Prepared by:Dharia McGrew / HEALTH / (916) 319-2097