BILL ANALYSIS Ó
AB 1823
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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,
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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:
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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,
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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.
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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
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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
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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.
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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
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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
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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
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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 the
foundation fund does not receive five hundred?"
REGISTERED SUPPORT / OPPOSITION:
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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.
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Analysis Prepared by:Dharia McGrew / HEALTH / (916) 319-2097