BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1823
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|AUTHOR: |Bonilla |
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|VERSION: |May 27, 2016 |
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|HEARING DATE: |June 22, 2016 | | |
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|CONSULTANT: |Reyes Diaz |
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SUBJECT : California Cancer Clinical Trials Program
SUMMARY : Requests the University of California (UC) to create a Board of
Trustees of the California Cancer Clinical Trials Program, as
specified, which would provide grants to increase patient access
to eligible cancer clinical trials in underserved or
disadvantaged communities, as specified. Allows the UC to
decline to establish or participate in, and to terminate, the
program, as specified.
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 and members of minority groups, as specified, are
included as subjects in 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 (trial) if the enrollee's
treating physician recommends participation in the trial,
after determining such participation has a meaningful
potential to benefit the enrollee or insured.
This bill:
1)Requests the UC to establish or designate an institute or
office within the UC to administer the California Cancer
Clinical Trials Program (CCTP) and to establish a Board of
Trustees of the CCTP (Board) that:
AB 1823 (Bonilla) Page 2 of ?
a) Consists of at least five members (who serve
without compensation, with exception) appointed by the
president of the UC to represent institutions and
individuals performing, participating in, and
supporting eligible trials in California;
b) Has varying backgrounds to promote the
purposes of the CCTP, including the ability and desire
to solicit funds for the purpose of increasing and
diversifying access to eligible trials;
c) Is qualified through the experience,
expertise, and diversity of its members in the design,
implementation, and support of trials, and through
studying and addressing socioeconomic, ethnic or
racial, regional, and other barriers to participation,
and interventions to remove those barriers; and,
d) Makes efforts to include representatives of a
range of public and private research institutions,
health care providers, health care foundations, and
patient advocacy organizations.
2)Requires the Board to establish the CCTP, upon the program
administrator's receipt of at least $500,000 in funding, to
increase patient access to trials in underserved or
disadvantaged communities and populations, including women and
patients from racial and ethnic minority communities and
socioeconomically disadvantaged communities.
3)Requires the Board to determine the criteria to award and
administer grants, and allows the Board to award grants to any
or all of the following: a) public and private research
institutions and hospitals that conduct eligible trials; and
b) nonprofit organizations that are exempt from taxation, as
specified, and that either specialize in direct patient
support for improved trial enrollment and retention, or engage
in research on health disparities and their relationship to
trial enrollment.
4)Requires grants to be used for activities to increase patient
access to trials, including, but not limited to:
a) Patient navigator services or programs;
b) Education and community outreach;
c) Patient-friendly technical tools to assist
patients in identifying available trials;
d) Counseling services for trial participants;
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e) Well-being services for participants, as
specified;
f) Payment of ancillary costs for patients and
caregivers incurred during and related to
participation to include, but not limited to, airfare,
lodging, car rentals, meals, and dependent child care;
and,
g) Research on the effectiveness of these and
other measures to increase patient access to trials.
5)Requires the Board to require grantees to submit any reports
it deems necessary to ensure the appropriate use of funds.
Allows the UC to require the Board to submit reports
pertaining to CCTP and Board activities to the UC Regents,
including, but not limited to, accounting of funds collected
and expended, an evaluation of the CCTP, and recommendations
regarding the CCTP.
6)Encourages the Board, when determining grant recipients, to
grant special consideration to public and nonprofit applicants
that provide patient services related to trials that address
health disparities or that possess two or more years'
experience in the improvement of enrollment, retention, or
participation in trial participation with an emphasis on
underserved populations.
7)Requests the UC to publicize to National Cancer
Institute-Designated Cancer Centers, community organizations,
hospitals, hospital associations, industry, health care
foundations, and government agencies the opportunity to submit
nominations for Board membership to the president of the UC.
Requests the UC to publicize the availability of grants made
available through the CCTP to the entities specified in 3)
above.
8)Allows the UC to participate in the CCTP as the administrator,
a beneficiary, or both, and allows the UC to pursue any
federal, state, or internal approvals, authorizations, or
advice it deems necessary to the UC's participation. Allows
the UC to decline to establish or participate in, and to
terminate, the CCTP, as specified.
9)Allows the UC to directly or through a UC-affiliated
foundation solicit funds from business, industry, foundations,
research organizations, federal government agencies,
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individuals, and other private sources for the purpose of
administering the CCTP and awarding grants to increase patient
access to trials.
FISCAL
EFFECT : According to the Assembly Appropriations Committee:
1)One-time costs in the low hundreds of thousands to establish
the CCTP, develop grant guidelines, and provide initial
administrative support (unknown federal and private funds).
Any costs to an existing institute or office of the UC would
be reimbursed by the fund specified in the bill.
2)Unknown annual cost pressure to award grants and provide
administrative support for the new program (unknown federal
and private funds). The amount of grant funding the program
will be able to award will depend on future donations, as will
the level of administrative support needed to award the
grants. Given the types of direct services the grants are
expected to fund, it is reasonable to assume the level of
funding required to make this a meaningful program would be in
the millions annually.
PRIOR
VOTES :
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|Assembly Floor: |80 - 0 |
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|Assembly Appropriations Committee: |20 - 0 |
|Assembly Higher Education |13 - 0 |
|Committee: | |
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|Assembly Health Committee: |17 - 0 |
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COMMENTS :
1)Author's statement. According to the author, this bill will
help remedy the problem of low participation, especially for
underrepresented communities, in trials by creating a grant
program administered by the UC aimed at breaking down barriers
to trial participation. The opportunity to assess and evaluate
innovative treatments with participation from women and
underrepresented individuals allows researchers to properly
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test the effects of medication resulting in the opportunity to
develop robust treatments that meet the varying genetic
make-up of women and men of diverse racial/ethnic groups.
Unfortunately, there is currently no support for patients who
want to access trials. The clinicaltrials.gov Web site is
inadequate and not user friendly. Patients have found
difficulty in navigating the Web site and are unable to find
an appropriate trial that is suited for them and their disease
state. Some of the barriers to patient participation in trials
include the following: lack of awareness of the available
trials, mistrust of research and the medical system, loss of
income, transportation, and lodging costs. This bill will
create the CCTP, which will grant money to nonprofits and
research institutes focused on breaking down the barriers to
trial participation.
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 trials annually. It is
estimated that only about 3-5% of the 10.1 million adults with
cancer in the U.S. participate in 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 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.
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 trials, researchers
cannot learn about potential difference among groups and
cannot ensure the generalization of results. In addition,
participation in trials increases access to state-of-the-art
cancer care, a critical survival factor in many minority and
underrepresented populations that suffer disproportionately
from cancer.
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3)Issues with trial participation. According to a document
published by the Society for Women's Health Research and
United States Food and Drug Administration (FDA) Office of
Women's Health, "Dialogues on Diversifying Clinical Trials,"
the most important diseases that disproportionately affect
ethnic minorities include type 2 diabetes, cardiovascular
disease, stroke, infectious diseases (HIV/AIDS, STDs), and
different types of cancer (colon, prostate, cervix, and lung).
Many racial health disparities stem from lack of access to
quality health care and proper health awareness. Unfortunately
this means that incidence of disease does not always match
trial populations. For example, African Americans represent
12% of the U.S. population but only 5% of trial participants.
Hispanics make up 16% of the population but only 1% of trial
participants. Sex distribution in cardiovascular device trials
is 67% male. According to the American Cancer Society Cancer
Action Network, only approximately 3% of adults diagnosed with
cancer participate in trials, and the participation rate is
lower for people who are racial and ethnic minorities,
elderly, low-income, and live in rural areas.
The Coalition to Eliminate Disparities and to Research
Inclusion in Clinical Trials identified minority lack of
disease education as a major barrier to recruitment. Other
significant barriers to diversify enrollment, as reported by
investigators and coordinators, are insurance status, patient
inconvenience costs, availability of transportation, distance
to the study site, and patient and family concerns about risk.
However, race, age, and sex have been shown to play more
significant roles in trial participation compared to proximity
to trial location.
4)Double referral. If this bill passes out of this committee, it
will be referred to the Senate Education Committee.
5)Prior legislation. AB 1060 (Bonilla of 2015), was similar to
this bill. AB 1060 was vetoed by Governor Brown who stated
that numerous private organizations already perform this
fundraising function, and while he supports eliminating
barriers to take part in trials, he was 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.
AB 2038 (Alquist, Chapter 250, Statutes of 2000), enacted the
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Inclusion of Women and Minorities in Clinical Research Act to
require any public, private or nonprofit agency conducting
clinical research using state funds to 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.
6)Support. Supporters argue that currently only 3% of eligible
cancer patients participate in trials, and of those patients
only 5% are from underrepresented communities, including
African Americans, Latinos/Hispanics, Asians and Pacific
Islanders, and American Indians. Supporters state that this
bill allows researchers to properly evaluate the effects of
new therapies and develop more robust treatments designed to
meet the varying genetic make-up of women, men, and diverse
racial/ethnic groups. Supporters further state that funds from
the grants will help cover expenses stemming from trial
participation, patient navigation, education and community
outreach, and implementing patient-friendly tools to assist
them in identifying available trials.
SUPPORT AND OPPOSITION :
Support: Lazarex Cancer Foundation (sponsor)
Association of California Healthcare Districts
Association of Northern California Oncologists
Business & Professional Women of Nevada County
California Academy of PAs
California Chronic Care Coalition
California Immigrant Policy Center
California Pharmacists Association
City of Hope National Medical Center
Community Health Partnership
Health Access California
Medical Oncology Association of Southern California
Pharmaceutical Researchers and Manufacturers of
America
Susan G. Komen California Collaborative
University of California
University of Southern California
Oppose: None received
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