BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1060|
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THIRD READING
Bill No: AB 1060
Author: Bonilla (D)
Amended: 8/31/15 in Senate
Vote: 21
SENATE HEALTH COMMITTEE: 9-0, 7/15/15
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/27/15
AYES: Lara, Bates, Beall, Hill, Leyva, Mendoza, Nielsen
ASSEMBLY FLOOR: 77-0, 5/7/15 (Consent) - See last page for
vote
SUBJECT: Cancer clinical trials
SOURCE: Lazarex Cancer Foundation
DIGEST: This bill 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.
ANALYSIS:
Existing law:
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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
U.S. Food and Drug Administration (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.
This bill:
1)Requires 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 five-member board, appointed by the Governor, the Speaker of
the Assembly, and the Pro Tempore of the Senate with a
four-year term.
2)Creates the Cancer Clinical Trials Fund for the administration
and support of the program. Requires moneys in the fund to be
appropriated by the Legislature.
3)Permits 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. Permits
applications for federal funds.
4)Requires the board to use no more than 20% of funds made
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available for the Cancer Clinical Trials Grant Program for
administrative costs.
5)Limits CHHS from spending more than $300,000 to establish the
foundation and requires the foundation to pay the funds back
on or before January 1, 2021. Prohibits General Fund moneys
to be used to operate the foundation.
6)Requires, 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.
7)Requires 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 FDA and nonprofit
organizations that specialize in direct patient support for
improved clinical trial enrollment and retention, as
specified.
8)Requires the board to report to the Legislature to ensure the
appropriate use of the funds. Requires the report to include
accountability measures, including, but not limited to, a
description of how the funds were used, an evaluation of the
grant program, and recommendations for the program, and to be
submitted by January 1, 2020.
9)Requires the foundation to return moneys to the donors on a
pro rata basis, after the repayment required in 3) above, if
the foundation does not receive $500,000 or more by January 1,
2021. Sunsets this bill on January 1, 2022.
Comments
1)Author's statement. According to the author, access to
clinical trials is an important part of our health care
system. It allows people to try innovative, alternative
treatments when traditional treatments have not been
successful and helps to get these new treatments approved for
mainstream use. Unfortunately, we have seen limited access to
clinical trials for women and people of color. One of the top
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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. In addition, there are other barriers to trials such
as lack of education and awareness of available cancer
clinical trials. AB 1060 takes a step to increase access to
cancer clinical trials by creating a privately funded grant
program to connect patients with the appropriate clinical
trial.
2)Clinical Trial Patient Challenges. According to a 2010
Workshop Summary of Transforming Clinical Research in the
United States, many workshop participants noted that patients
often are unaware of the possibility of enrolling in a
clinical trial. If they are aware of this opportunity, it is
often difficult for them to locate a trial. Patients may
reside far from study centers; even the largest multicenter
trials can pose geographic challenges for those wishing to
participate. Depending on the number of clinic visits required
by the study protocol, significant travel and time costs may
be associated with participation. In addition, trials designed
with narrow eligibility criteria for participation purposely
eliminate many patients who might have the disease being
studied but are ineligible because of other characteristics
(e.g., age, level of disease progression, exposure to certain
medicines). Trials often require patients to temporarily
leave the care of their regular doctor and receive services
from unfamiliar providers, confronting interruptions in care.
If a patient reaches the point of enrolling in a clinical
trial, the extensive paperwork associated with the informed
consent process can be confusing and burdensome. Informed
consent forms are developed to meet legal requirements and can
contribute to the confusion patients feel regarding the trial
and what it entails. In addition, there is sometimes a
mistrust of industry-sponsored trials among the public. These
feelings of mistrust can further complicate the already
difficult decision about whether to join a trial.
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. 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. With regard to challenges, the Fact
Sheet indicates that 85% of respondents to a national survey
were unaware that participating in a clinical trial was a
treatment option for them. According to a review of
enrollment decisions for health research studies, racial and
ethnic minorities were less likely to be invited to
participate in research studies compared with
non-Hispanic/Latino whites.
FISCAL EFFECT: Appropriation: Yes Fiscal
Com.:YesLocal: No
According to the Senate Appropriations Committee:
1)Anticipated 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).
2)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.
SUPPORT: (Verified8/28/15)
Lazarex Cancer Foundation (source)
Association of Northern California Oncologists
Biocom
California Life Sciences Association
Pharmaceutical Researchers and Manufacturers of America
Stanford Healthcare
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University of Southern California
OPPOSITION: (Verified8/28/15)
None received
ARGUMENTS IN SUPPORT: According to the Lazarex Cancer
Foundation this bill seeks to remedy the problem of low patient
participation in clinical trials, especially participation by
women and underrepresented communities. Lazarex states that the
American Medical Association conducted a study on cancer trial
participation and found from 1996 to 2002, of the 75,215
patients enrolled in the National Cancer Institute trials for
breast, lung, colorectal, and prostate cancers, only 3.1% were
Hispanic, 9.2% were black, and 1.9% were Asian/Pacific
Islanders, while 85.6% were white. The lack of diversity
impacts researcher's ability to evaluate the effect of new
treatments on different populations, and speaks to a lack of
access to potentially lifesaving trials for a large portion of
the populations. The Association of Northern California
Oncologists Board of Directors writes that clinical trials are
an essential component of developing new and innovative
treatments for all types of cancer and give vulnerable patients
access to new treatment options that would not otherwise be
available to them. This new foundation could raise funds to
overcome barriers, helping the entire research process. The
University of Southern California writes that this bill is an
innovative approach focused on addressing barriers to patient
participation in clinical trials. Biocom writes that although
many companies operating in this space already have established
programs to address this issue of clinical trial participation
in underrepresented communities, it is hoped that a concerted
state effort may reach trial candidates and their physicians
more effectively.
ASSEMBLY FLOOR: 77-0, 5/7/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Chang, Chau,
Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly,
Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina
Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,
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Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones,
Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,
Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,
Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea,
Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Mark
Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams,
Wood, Atkins
NO VOTE RECORDED: Campos, Roger Hernández, Steinorth
Prepared by:Teri Boughton / HEALTH /
8/31/15 12:47:53
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