BILL ANALYSIS Ó
AB 1823
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HIGHER EDUCATION
Jose Medina, Chair
AB 1823
(Bonilla) - As Amended April 12, 2016
[Note: This bill was heard by the Assembly Health Committee on
March 15, 2016, and approved by a vote of 17-0.]
SUBJECT: California Cancer Clinical Trials Program
SUMMARY: Requests the University of California (UC) establish
and designate a nonprofit public benefit corporation to solicit
and receive funds from business, industry, foundations, and
other sources for the Cancer Clinical Trials Program (Program)
to increase patient access to clinical trials. Specifically,
this bill:
1)Finds and declares all of the following:
a) According to the 2016 report of the Public Policy
Institute of California entitled California's Future:
Health Care, significant health disparities exist among
socioeconomic, racial, ethnic, and regional groups in
California. African Americans and persons with a high
school education or less have significantly lower life
expectancies than other groups of people, and individuals
in some regions of the state or in particular communities
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face other significant health obstacles.
b) The ability to translate medical findings from research
to practice relies largely on having robust patient
participation and a diverse participation pool. A low
participation rate or a homogenous participant group
prevents segments of the population from benefiting from
advances achieved through clinical research and creates
uncertainties over the applicability of research findings.
Diverse patient participation in a clinical trial depends,
in part, on whether a participant can afford ancillary
costs like transportation, child care, or lodging during
the course of his or her participation. A national study in
2015 found that patient households making less than $50,000
annually were almost 30 percent less likely to participate
in clinical trials. This disparity threatens one of the
most basic ethical underpinnings of clinical research, the
requirement that the benefits of research be made available
equitably among all eligible individuals.
c) California is home to the following 10 National Cancer
Institute-Designated Cancer Centers that perform cancer
clinical trials research: University of California,
Irvine, Chao Family Comprehensive Cancer Center; City of
Hope Comprehensive Cancer Center; University of California,
Los Angeles, Jonsson Comprehensive Cancer Center; Salk
Institute Cancer Center; Sanford Burnham Prebys Medical
Discovery Institute; Stanford Cancer Institute; University
of California, Davis, Comprehensive Cancer Center;
University of California, San Diego, Moores Cancer Center;
University of California, San Francisco, Helen Diller
Family Comprehensive Cancer Center; University of Southern
California, Norris Comprehensive Cancer Center.
d) Cancer is the cause of almost one in four deaths in
California. It is the second leading cause of death for
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Californians and the primary cause of death among
Californian Asian/Pacific Islanders. A Californian will be
diagnosed with cancer approximately every four minutes, and
every ten minutes a Californian will die of cancer. African
American Californians in particular face disproportionally
higher rates of cancer incidence and mortality compared to
other races and ethnicities.
e) Addressing barriers faced by medically underserved and
underrepresented individuals in cancer and other clinical
trials and improving access to survivorship resources and
services through partnerships with hospitals, regional and
community cancer centers, and nonprofit organizations are
some of the strategies recommended by the California
Dialogue on Cancer, established in 2002 by California's
Comprehensive Cancer Control Program to reduce the burden
of cancer in California.
f) According to the National Cancer Institute Cancer
Clinical Trials Resource Guide, some of the barriers
preventing individuals with cancer or at high risk of
developing cancer from participating in clinical trials are
direct and indirect financial and personal costs, including
travel and child care expenses.
g) It is the finding of the Legislature that some
corporations, individuals, public and private foundations,
and other stakeholders are hesitant to contribute to, or
accept funds from, programs that are organized to alleviate
financial burdens, and that there are disincentives faced
by patients who wish to participate in clinical trials and
their caregivers.
h) It is the intent of the Legislature to enact legislation
that would establish a program to authorize business,
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industry, public and private foundations, individuals, and
other stakeholders to donate to the program described in
this act, as well as to other nonprofit corporations and
public charities that specialize in the enrollment,
retention, and increased participation of patients in
cancer clinical trials.
i) It is the intent of the Legislature to enact legislation
that would establish a program to better enable donors
willing to assist clinical research participants from
communities that have documented low levels of access to
health services or participation in clinical trials, face
financial barriers to participation in clinical trials, or
have been identified as priorities for health services, to
participate in clinical trials by supporting ancillary
costs to boost participation rates among the research
participant populations, ensure these trials are widely
accessible, improve the development of therapies, and
enhance innovation.
2)Requests UC to do all of the following:
a) Establish or designate an institute or office within the
university to administer the program.
b) Establish the board to consist of at least five members,
appointed by the UC president to represent institutions and
individuals performing, participating in, and supporting
eligible cancer clinical trials in California. Requires
the members of the board to have, among other requirements,
varying backgrounds to promote the purpose of the Program.
3)Provides that, prior to establishing the board, UC may pursue
any federal, state, or international approvals, authorizations
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or advice necessary for participation in the Program.
Provides that the board may use no more than 20% of funds for
administrative costs of the Program.
4)Provides that the board may solicit and receive funds from
public and private sources and that money expended by UC to
establish and operate the Program shall be reimbursed from
donated moneys. Provides that UC may terminate the Program if
it is determined unviable.
5)Provides that upon receipt of at least $500,000 the board
shall establish the Program to provide grants to any or all of
the following:
a) Public and private research institutions and hospitals
that conduct eligible cancer clinical trials.
b) Nonprofit organizations that specialize in direct
patient support for improved clinical trial enrollment and
retention or engage in research on health disparities and
their relationship to clinical trial enrollment.
6)Provides that grants awarded shall be used for activities to
increase patient access to eligible 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
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identifying available clinical trials;
d) Counseling services for clinical trial participants;
e) Well-being services for clinical trial participants,
including, but not limited to, physical therapy, pain
management, stress management, and nutrition management;
f) Provide payments for patients and caregivers may include
costs related to participation in the trial, including
airfare, lodging, meals, transportation, etc; and,
g) Research on the effectiveness of these and other
measures to increase patient access to clinical trials.
7)Provides that when determining program grant recipients the
board is encouraged to grant special consideration to public
or nonprofit applicants that provide patient services related
to cancer clinical trials that address health disparities or
that possess two or more years' experience in the improvement
of enrollment, retention, or participation in cancer clinical
trial participation with an emphasis on underserved
populations.
8)Provides that the board shall require grantees to submit any
reports it deems necessary to ensure the appropriate use of
funds consistent with the purposes of this part and the terms
of any grant awards.
9)Provides that UC may require the board to submit reports, as
specified, pertaining to the board's activities to the UC
Regents.
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10)Provides that if UC determines at any time that the moneys in
the fund are insufficient to establish or sustain the program,
UC may terminate the program; all moneys in the fund remaining
after expenses are paid shall, prior to dissolution, be
allocated to one or more grant organizations.
11)Provides that if the fund does not receive $500,000 or more
by January 1, 2021, or, if at any time, the board determines
that the 20% limit on administrative costs is inadequate to
support the cost of administering the Program, moneys
remaining after the repayment shall be returned to the donors
on a pro rata basis.
EXISTING LAW: Establishes UC as a public trust and confers the
full powers of the UC upon the UC Regents. The Constitution
establishes that the UC is subject to legislative control only
to the degree necessary to ensure the security of its funds and
compliance with the terms of its endowments. Judicial decisions
have held that there are three additional areas in which there
may be limited legislative intrusion into university operations:
authority over the appropriation of state moneys; exercise of
the general police power to provide for the public health,
safety and welfare; and, legislation on matters of general
statewide concern not involving internal university affairs.
(Constitution of California, Article IX, Section 9)
FISCAL EFFECT: Unknown.
COMMENTS: Purpose of this bill. According to the author, 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,
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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 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.
Background. According to the Assembly Health Committee
analysis, the National Cancer Institute notes 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 underrepresented
among participants in cancer-related trials. Without adequate
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representation of these populations in clinical trials,
researchers cannot learn about potential differences 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 underrepresented populations that suffer
disproportionately from cancer.
Committee staff notes that, according to information provided by
UC, clinical trials conducted by UC generally have higher
participation than the national average from underrepresented
minority populations. Figures can range in the 13%-16%
participation rate.
Previous legislation. AB 1060 (Bonilla) of 2015, was similar to
this bill. It was vetoed by Governor Brown, citing, in part,
"numerous 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 which is managing a huge
expansion of our health care system. This bill responds to the
Governor's veto message by moving administrative responsibility
from HHS to the UC."
Requested amendments. The University of Southern California
(USC) has expressed concerns on the appointments structure for
the Program board. Specifically, USC notes the USC Norris
Comprehensive Cancer Center focuses on testing new therapies for
cancer, optimizing existing treatments, discovering prevention
methods and developing ways to improve quality of life. USC
notes the center is one of the nation's 41 comprehensive cancer
centers. According to USC, the board appointment structure
should be amended to provide more qualifiers to ensure those
with sufficient expertise in cancer treatment serve on the
board.
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REGISTERED SUPPORT / OPPOSITION:
Support
Association of California Healthcare Districts
Association of Northern California Oncologists
California Academy of PA's
California Chronic Care Coalition
California Immigrant Policy Center
City of Hope
Health Access California
Lazarex Cancer Foundation
Pharmaceutical Researchers and Manufacturers of America
Susan G. Komen California Collaborative
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University of California
Opposition
None on File
Analysis Prepared by:Laura Metune / HIGHER ED. / (916) 319-3960