BILL ANALYSIS Ó
AB 1060
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CONCURRENCE IN SENATE AMENDMENTS
AB
1060 (Bonilla)
As Amended August 31, 2015
Majority vote
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|ASSEMBLY: | |(May 7, 2015) |SENATE: |39-0 |(September 3, |
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(vote not relevant)
Original Committee Reference: B. & P.
SUMMARY: 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.
The Senate amendments delete the Assembly-approved contents of
this bill and instead:
1)Require 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
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five member board, appointed by the Governor, the Speaker of
the Assembly, and the Pro Tem of the Senate with a four year
term.
2)Require the Governor to appoint the president of the board and
requires members of the board to serve without compensation
but reimbursed for any actual and necessary expenses incurred
in connection with their duties as members of the board.
3)Subjects the foundation to the Nonprofit Public Benefit
Corporation Law, as specified, except that if there is a
conflict with this bill and the Nonprofit Public Benefit
Corporation Law, this bill shall prevail.
4)Require CHHS to determine which department in the agency shall
administer the foundation.
5)Create the Cancer Clinical Trials Fund within the State
Treasury, appropriated by the Legislature to the board for the
administration and support of the program.
6)Permit 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 to increase patient
access to cancer clinical trials.
7)Permit CHHS to apply for federal funds.
8)Require the board to use no more than 20% of funds made
available for the Cancer Clinical Trials Grant Program for
administrative costs.
9)Limit spending for the establishment of the foundation to
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$300,000. Require startup funds used to establish the
foundation be repaid with donations by 2021. Prohibit, after
the initial investment, General Fund moneys from being used to
operate the foundation.
10)Require, 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.
11)Require 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 federal Food and Drug
Administration (FDA) and nonprofit organizations that
specialize in direct patient support for improved clinical
trial enrollment and retention, as specified.
12)Require 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;
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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;
and,
g) Payment of ancillary costs for patients and caregivers,
including, but not limited to: airfare during the clinical
trial, lodging during the clinical trial, rental cars
during the clinical trial, fuel during the clinical trial,
local transportation via bus, train, or other public
transportation during the clinical trial, meals during the
clinical trial, and child care costs during the clinical
trial.
13)Specify repayment requirements if the foundation does not
meet financial goals.
14)Require grant recipients to report to the board to ensure the
appropriate use of funds within one year of receiving a grant.
15)Require the board to report to the Legislature specified data
and recommendations by January 1, 2020. Makes the requirement
for submitting a report inoperative on January, 1, 2024.
16)Sunset the provisions of this bill on January 1, 2022.
17)State 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 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
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.
FISCAL EFFECT: According to the Senate Appropriations
Committee, 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). 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.
COMMENTS:
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1)Purpose of the Bill. The author states that this bill would
increase participation of underrepresented communities in FDA
approved clinical trials by creating a privately funded state
grant program to help patients pay for the ancillary cost
associated with participation in these trials. Studies show
that there are a disproportionately low number of patients
from minority communities in clinical trials of new drugs and
cancer therapies. According to the author, one of the top
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. Clinical trials do not pay these ancillary costs.
The costs fall onto the clinical trial participant who may be
unable to pay and therefore, unable to enroll in the trial.
The author contends that this bill creates an opportunity for
the state to leverage public-private partnerships to improve
the health and wellbeing of its residents with limited state
investment.
2)Background. According to the Intercultural Cancer Center,
only about 3 to 5% of the 10.1 million adults with cancer in
the United States (U.S.) participate in cancer clinical
trials. 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
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 minorities and underrepresent
populations that suffer disproportionately from cancer.
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
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trials. This compares to 60% participation rate for children
with cancer. The National Cancer Institute is the largest
sponsor of cancer clinical trials at 3,000 sites. Over 30,000
patients are enrolled in cancer clinical trials annually. 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.
4)Barriers To Trial Participation. The Coalition to Eliminate
Disparities and to Research Inclusion in Clinical Trials
(CEDRICT) identified minority lack of disease education as a
major barrier to recruitment. 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. They include, among many other things:
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 and others 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 a 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.
5)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
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
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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", 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.
This bill was substantially amended in the Senate and the
Assembly-approved provisions of this bill were deleted. This
bill, as amended in the Senate is inconsistent with Assembly
actions.
Analysis Prepared by:
Dharia McGrew / HEALTH / (916) 319-2097 FN:
0001888