BILL ANALYSIS Ó
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2015 - 2016 Regular Session
AB 1823 (Bonilla) - California Cancer Clinical Trials Program
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|Version: June 23, 2016 |Policy Vote: HEALTH 9 - 0, ED. |
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|Urgency: No |Mandate: No |
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|Hearing Date: August 8, 2016 |Consultant: Jillian Kissee |
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This bill meets the criteria for referral to the Suspense File.
Bill
Summary: This bill requests the University of California (UC)
to establish a board to solicit and receive funds from federal
or private sources for the California Cancer Clinical Program
(Program) to provide grants to increase patient access to
eligible cancer clinical trials in underserved or disadvantaged
communities.
Fiscal
Impact:
Start-up: Unknown one-time General Fund cost pressure for the
UC to provide oversight and administration of the Program
related to initial start-up activities. These costs are
AB 1823 (Bonilla) Page 1 of
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required to be reimbursed by moneys donated to the fund
(federal or private funds) prior to awarding grants, thereby
offsetting the use of state funds. This bill also provides
that if the UC determines at any time that the moneys in the
fund are insufficient to establish or sustain the Program, it
may be terminated.
Unknown federal or private funds to administer the Program and
award grants. In order to have a viable Program and offer
services as described in this bill, UC indicates that funding
would likely need to be in the millions. The scope of the
Program, including the number of grantees, grant amounts, and
administrative support to operate the Program would depend
upon future donations.
Background: Clinical trials are conducted by pharmaceutical companies
seeking approval to market new drugs or existing drugs for
additional conditions. In addition, the federal government
provides financial support for clinical trials designed to study
medical effectiveness or other characteristics of new or
existing drugs.
In recent years, concerns have been raised that participants in
clinical trials tend not to reflect the larger society, which
may bias the results of those trials. Research findings
indicate that participants in clinical trials are more likely to
be male and to be Caucasian than the general population.
Clinical trials tend to be conducted at academic medical
centers, often requiring patients to receive their care from a
new doctor participating in the trial and often requiring
substantial paperwork for patients to enroll. These factors and
others have tended to limit participation in clinical trials.
According to the author, barriers to participation include a
lack of awareness, mistrust of research and the medical system,
loss of income, and transportation and lodging costs. These
ancillary costs of participation fall onto the clinical trial
participant who may be unable to pay, and therefore unable to
enroll in the trial. The intent of this bill is to assist
patients in in paying for the ancillary costs associated with
participation in these trials.
AB 1823 (Bonilla) Page 2 of
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Proposed Law:
This bill requests the UC to establish a board to solicit and
receive funds from federal or private sources for the California
Cancer Clinical Program (Program) to provide grants to increase
patient access to eligible cancer clinical trials in underserved
or disadvantaged communities.
Key provisions of the bill include:
Prior to establishing the Program, the UC may pursue any
federal, state, or internal approvals, authorizations, or
advice it deems necessary.
The UC is authorized to use its own state funds for
oversight and administration of the Program relating to the
initial start-up costs only.
Any resources provided by the UC to establish and
operate the Program are required to be reimbursed from
moneys donated in the fund prior to distribution of any
grants.
Only federal or private funds may be used to administer
the Program.
Funds may be provided to research institutions and
hospitals that conduct eligible cancer clinical trials and
nonprofit organizations, as specified.
Funds may be used for a number of activities, including
but not limited to, technical assistance tools to assist
patients in identifying available clinical trials, and
payment of ancillary costs related to participation in the
clinical trial, such as airfare, lodging, child care, and
meals.
If the UC determines at any time that the moneys in the
fund are insufficient to establish or sustain the Program,
the UC may terminate the Program.
Similarly, if the fund does not receive at least
$500,000 by January 1, 2021 or if it is determined that the
administrative support allocation allowed by this bill is
insufficient, the Program administrator may elect to
dissolve the program.
Related
Legislation: AB 1060 (Bonilla, 2015) proposed establishment of
the Cancer Clinical Trials Foundation in the Health and Human
Services Agency to administer a grant program substantively
similar to that proposed by this bill. AB 1060 was vetoed by
AB 1823 (Bonilla) Page 3 of
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the Governor whose message read, 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 establishes the program in the UC
instead of within a state agency.
Staff
Comments: According to the UC, in order to operate this
Program, it must first receive approval from the federal Office
of Inspector General. Once approval is received, the UC can
receive donations, of which at least $500,000 is required to
begin providing grants to increase patient access to eligible
cancer clinical trials. According to the UC, this bill outlines
the structure of the program that would meet federal approval.
The UC has already expended state funds for purposes of gaining
permission from federal regulators and engaging in other
administrative activities to establish the Program. This bill
specifies that any resources provided by the UC to establish and
operate the Program are required to be reimbursed from moneys
donated in the fund prior to distribution of any grants. The
ongoing operation of the Program is intended to be supported
entirely by private and federal funds.
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