BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1060
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|AUTHOR: |Bonilla |
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|VERSION: |June 17, 2015 |
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|HEARING DATE: |July 15, 2015 | | |
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|CONSULTANT: |Teri Boughton |
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SUBJECT : Cancer clinical trials.
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.
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
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.
AB 1060 (Bonilla) Page 2 of ?
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 Tem of the Senate with a four year
term.
2)Requires 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)Requires CHHS to determine which department in the agency
shall administer the foundation.
5)Creates the Cancer Clinical Trials Fund, continuously
appropriated to the board without regard to fiscal years, for
the administration and support of the program.
6)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 to increase patient
access to cancer clinical trials.
7)Requires the board to use no more than 20% of funds made
available for the Cancer Clinical Trials Grant Program for
administrative costs.
8)Requires, upon contribution of an unspecified amount of moneys
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.
9)Requires the board to determine the criteria to award grants,
and authorize grants to be awarded to either or both, public
AB 1060 (Bonilla) Page 3 of ?
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.
10)Requires 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;
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.
11)Requires grant recipients to report to the board to ensure
the appropriate use of funds within one year of receiving a
grant.
12)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.
13)Makes the requirement for submitting a report imposed under
this bill inoperative on January, 1, 2024, as specified.
AB 1060 (Bonilla) Page 4 of ?
14)States 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.
FISCAL
EFFECT : This version of the bill has not been analyzed by a
fiscal committee.
PRIOR
VOTES : The prior votes are not relevant to this version of the
bill.
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
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 Challenges. A 2010 Workshop Summary of
Transforming Clinical Research in the United States (Summary)
provides some background into the clinical trial process.
According to the summary, because clinical trials are
necessary to obtain regulatory approval in the United States,
they are a high priority to companies. Industry-sponsored
trials are conducted largely to gain FDA approval to market a
new drug or a previously approved drug for a new indication.
Pre-approval trials include a simple protocol (i.e., ask a
limited number of questions) and test a drug in a highly
selected patient group designed to provide the most robust
evidence on the drug's benefits and risks. Conversely, the
AB 1060 (Bonilla) Page 5 of ?
federal government conducts large clinical trials to answer
medical questions unrelated to gaining regulatory approval for
a new drug or therapy. These studies can involve a wide range
of patients and seek to answer a number of relevant clinical
questions at once.
Clinical trial costs can vary widely depending on the number
of patients being sought, the number and location of research
sites, the complexity of the trial protocol, and the
reimbursement provided to investigators. The total cost can
reach $300-$600 million to implement, conduct, and monitor a
large, multicenter trial to completion.
The Summary includes a discussion about patient challenges.
According to the summary, 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
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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
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. 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.
4)Prior legislation. AB 2038 (Alquist Chapter 250, Statutes of
2000), establishes the Inclusion of Women and Minorities in
Clinical Research Act.
5)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. 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 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
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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.
6)Amendments. The author requests the adoption of amendments to
direct the foundation, or an authorized representative
thereof, to apply for tax exempt status under Section 501
(c)(3) of the Internal Revenue Code.
SUPPORT AND OPPOSITION :
Support: Lazarex Cancer Foundation (sponsor)
Association of Northern California Oncologists
Biocom
California Life Sciences Association
Pharmaceutical Researchers and Manufacturers of
America
University of Southern California
Oppose: None received
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