BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1823|
|Office of Senate Floor Analyses | |
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THIRD READING
Bill No: AB 1823
Author: Bonilla (D), et al.
Amended: 8/2/16 in Senate
Vote: 21
SENATE HEALTH COMMITTEE: 9-0, 6/22/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE EDUCATION COMMITTEE: 9-0, 6/29/16
AYES: Liu, Block, Hancock, Huff, Leyva, Mendoza, Monning, Pan,
Vidak
SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16
AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen
ASSEMBLY FLOOR: 80-0, 6/1/16 - See last page for vote
SUBJECT: California Cancer Clinical Trials Program
SOURCE: Lazarex Cancer Foundation
DIGEST: This bill 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.
ANALYSIS:
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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 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:
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;
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; and,
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e) Has 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.
2)Requires a program administrator 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;
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 a program administrator 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,
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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 to applicants 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 a program administrator to directly or through a
UC-affiliated foundation solicit funds from business,
industry, foundations, research organizations, federal
government agencies, individuals, and other private sources
for the purpose of administering the CCTP and awarding grants
to increase patient access to trials, consistent with
guidelines developed by the Board.
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
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to trial participation. The opportunity to assess and evaluate
innovative treatments with participation from women and
underrepresented individuals allows researchers to properly
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)Clinical trails. 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,
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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.
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.
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
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Services Agency (HHS) which is managing a huge expansion of our
health care system.
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 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.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
According to the Senate Appropriations Committee:
1)Start-up: Unknown one-time General Fund cost pressure for the
UC to provide oversight and administration of the CCTP related
to initial start-up activities. These costs are required to
be reimbursed by moneys donated to the fund (federal or
private funds) prior to awarding grants, thereby offsetting
the use of state funds. This bill also provides that if the UC
determines at any time that the moneys in the fund are
insufficient to establish or sustain the CCTP, it may be
terminated.
2)Unknown federal or private funds to administer the CCTP and
award grants. In order to have a viable Program and offer
services as described in this bill, UC indicates that funding
would likely need to be in the millions. The scope of the
CCTP, including the number of grantees, grant amounts, and
administrative support to operate the CCTP, would depend upon
future donations.
SUPPORT: (Verified8/12/16)
Lazarex Cancer Foundation (source)
Association of California Healthcare Districts
Association of Northern California Oncologists
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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
OPPOSITION: (Verified8/12/16)
None received
ARGUMENTS IN 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.
ASSEMBLY FLOOR: 80-0, 6/1/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,
Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,
Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley,
Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth
Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto,
Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper,
Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim,
Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis,
AB 1823
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Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte,
O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez,
Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting,
Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
Prepared by:Reyes Diaz / HEALTH / (916) 651-4111
8/15/16 19:47:25
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