BILL ANALYSIS Ó
AB 1060
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CONCURRENCE IN SENATE AMENDMENTS
AB
1060 (Bonilla)
As Amended August 31, 2015
Majority vote
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|ASSEMBLY: | |(May 7, 2015) |SENATE: |39-0 |(September 3, |
| | | | | |2015) |
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(vote not relevant)
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|COMMITTEE VOTE: |17-1 |(September 9, |RECOMMENDATION: |concur |
| | |2015) | | |
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(HEALTH)
Original Committee Reference: HEALTH
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, and diverse participation in, cancer clinical
trials.
The Senate amendments delete the previous Assembly-approved
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provisions of this bill and replace contents with this bill.
FISCAL EFFECT: According to the Senate Appropriations Committee,
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). 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.
COMMENTS: The author states that this bill would increase
participation of underrepresented communities in United States
(U.S.) Food and Drug Administration approved clinical trials by
creating a privately funded state grant program to help patients
pay for the ancillary cost associated with participation in these
trials. Studies show that there is a disproportionately low
number of patients from minority communities in clinical trials of
new drugs and cancer therapies. There are many costs associated
with participating in a clinical trial including transportation
costs, hotel costs, and companion traveling expenses. Clinical
trials do not pay these ancillary costs. The costs fall onto the
clinical trial participant who may be unable to pay and therefore,
unable to enroll in the trial. The author contends that this bill
creates an opportunity for the state to leverage public-private
partnerships to improve the health and wellbeing of its residents
with limited state investment.
According to the Intercultural Cancer Center, only about 3% to 5%
of the 10.1 million adults with cancer in the U.S. participate in
cancer clinical trials. 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 representation of these populations in clinical
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trials, researchers cannot learn about potential difference 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 underrepresent populations that suffer
disproportionately from cancer.
1)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% to 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 Food and Drug Administration approved drugs from 1995
to 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 Selenium and Vitamin E
Cancer Prevention Trial (SELECT) prostate cancer prevention
trial completed recruiting over 35,000 men of whom 21% were
minorities.
2)Barriers to Trial Participation. There are many different
factors that have been attributed, in part, to the very low
participation rate of all eligible patients in clinical trials,
and the disproportionately low participation rate of minority
populations. They include, among many other things:
a) Lack of awareness: A national survey of cancer patients
found that 85% of respondents were unaware that participating
in a clinical trial was a treatment option for them.
b) Language/Linguistic differences: Many U.S. clinical
trials require English proficiency for potential
participants, automatically excluding those who do not speak
the language. Language factors also pose a serious barrier
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to provider-patient communication.
c) Practical obstacles: Transportation to and from a trial,
particularly if it is located in a distant location, can be a
barrier for many patients.
d) Public misconception: Among patients that are aware of
clinical trials, a large percentage choose not to enroll,
often due to a fear of getting a placebo in place of actual
treatment, belief that standard treatment is better than what
they would be offered in a clinical trial and fear of being a
"guinea pig." In fact, placebos are rarely used in cancer
treatment trials, and never in lieu of standard treatment.
e) Physician lack of awareness: Primary care physicians do
not have sufficient information on available clinical trials,
fail to refer patients to trials, and often leave the
discussion of clinical research to the patient's oncologist.
Yet, many oncologists outside of the academic setting may
also not be aware of trials or otherwise choose not to
participate in or refer their eligible patients to clinical
trials.
The University of Southern California writes in support that this
bill will help improve patient access, especially for women and
underrepresented minorities, to clinical trials by establishing a
privately-funded state grant program. The current lack of
diversity in clinical trial participants is alarming and
negatively impact the ability of researchers to evaluate the
effect of new treatments on different populations.
There is no known opposition to this bill.
Analysis Prepared by: Dharia McGrew / HEALTH / (916) 319-2097
FN: 0002341
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