BILL ANALYSIS Ó
AB 1060
Page 1
GOVERNOR'S VETO
AB
1060 (Bonilla)
As Enrolled September 14, 2015
2/3 vote
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|ASSEMBLY: | |(May 7, 2015) |SENATE: |39-0 |(September 3, |
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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)
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|ASSEMBLY: |72-6 |(September 10, | | | |
| | |2015) | | | |
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Original Committee Reference: B. & P.
AB 1060
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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
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.
AB 1060
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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 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
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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 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.
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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.
GOVERNOR'S VETO MESSAGE:
This bill would direct the California Health and Human Services
Agency to create a non-profit foundation to solicit donations to
fund participation in cancer clinical trials."
"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.
Analysis Prepared by: Dharia McGrew / HEALTH / (916) 319-2097
AB 1060
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