BILL ANALYSIS Ó
AB 1823
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ASSEMBLY THIRD READING
AB
1823 (Bonilla)
As Amended May 27, 2016
Majority vote
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|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Health |17-0 |Wood, Maienschein, | |
| | |Bonilla, Burke, | |
| | |Campos, Dababneh, | |
| | |Cooley, Roger | |
| | |Hernández, Lackey, | |
| | |Nazarian, Olsen, | |
| | |Patterson, Rodriguez, | |
| | |Santiago, Steinorth, | |
| | |Thurmond, Waldron | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Higher |13-0 |Medina, Baker, Bloom, | |
|Education | |Chávez, Irwin, | |
| | |Jones-Sawyer, Levine, | |
| | |Linder, Low, Olsen, | |
| | |Santiago, Weber, | |
| | |Williams | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Appropriations |20-0 |Gonzalez, Bigelow, | |
AB 1823
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| | |Bloom, Bonilla, | |
| | |Bonta, Calderon, | |
| | |Chang, Daly, Eggman, | |
| | |Gallagher, Eduardo | |
| | |Garcia, Roger | |
| | |Hernández, Holden, | |
| | |Jones, Obernolte, | |
| | |Quirk, Santiago, | |
| | |Wagner, Weber, Wood | |
| | | | |
| | | | |
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SUMMARY: Requests the University of California (UC) establish
and designate an institute or office with the authority to
solicit and receive funds from business, industry, foundations,
and other private and federal sources for the purpose of
administering the Cancer Clinical Trials Program (the program)
to increase patient access to cancer clinical trials.
Establishes a five-member board to administer the program.
Requires the program, on receipt of funds totaling $500,000, to
establish the Cancer Clinical Trials Grant Program (Grant
Program) to increase patient access to cancer clinical trials in
underserved or disadvantaged communities and populations.
Limits administrative expenses to 20% of funds raised. Allows
UC to discontinue the program for various reasons.
FISCAL EFFECT: According to the Assembly Appropriations
Committee:
1)One-time costs in the low hundreds of thousands to establish
the program, develop grant guidelines, and provide initial
administrative support (unknown federal and private funds).
Any costs to an existing institute or office of the UC would
be reimbursed by the fund specified in the bill.
AB 1823
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2)Unknown annual cost pressure to award grants and provide
administrative support for the new program (unknown federal
and private funds). The amount of grant funding the program
will be able to award will depend on future donations, as will
the level of administrative support needed to award the
grants. Given the types of direct services the grants are
expected to fund, it is reasonable to assume the level of
funding required to make this a meaningful program would be in
the millions annually.
COMMENTS: The author states that this bill seeks to remedy the
problem of low patient participation in the federal Food and
Drug Administration (FDA)-approved cancer clinical trials. More
importantly, there are a disproportionately low number of
patients in underrepresented communities including African
Americans, Latinos/Hispanics, Asians and Pacific Islanders, and
American Indians. The author asserts this problem will be
addressed by creating a privately funded state grant program to
help patients pay for the ancillary costs associated with
participation in these trials. Some of the barriers to patient
participation in clinical trials include the following: lack of
awareness of the available clinical trials, mistrust of research
and the medical system, and loss of income. Clinical trials do
not pay these ancillary costs associated with participation in a
clinical trial such as transportation, hotel stays, and
companion traveling expenses. The costs fall onto the clinical
trial participant who may be unable to pay and therefore, unable
to enroll in the trial.
According to a 2011 report titled "Successful Strategies for
Engaging Women and Minorities in Clinical Trials," the National
Institutes of Health (NIH) funded studies have specific
diversity requirements, but aside from FDA recommendations,
there are no regulations currently in place that require
industry sponsors to include women and minorities in their
trials. Diversity is not a natural priority for industry, where
decisions often are made by market attractiveness and potential
profit.
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According to the California Immigrant Policy Center, a supporter
of this bill, the lack of participation in clinical trials by
minority groups hinders the ability to develop robust treatments
that address the varying genetic make-up of women, men, and
diverse racial/ethnic groups. The opportunity to assess and
evaluate those innovative treatments with the participation of
women and underrepresented minorities allows researchers to
properly evaluate the true effects of new therapies. Health
Access California (HAC) states that over twenty years after
Congress mandated that research funded by the NIH include
minorities, little progress has been made to increase
participation among people of color. According to HAC, this
bill addresses some of the barriers to clinical trial
participation by creating the Program.
The University of Southern California supports this bill if it
were amended to provide that, at a minimum, one of the five
board members should be from the National Cancer Institute
designated comprehensive cancer centers. There is no known
opposition to this bill.
Analysis Prepared by:
John Gilman / HEALTH / (916) 319-2097 FN:
0003279
AB 1823
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