AB 1060, as amended, Bonilla. Cancer clinical trials.
Existing law establishes the scope and function of the California Health and Human Services Agency, which includes departments charged with administering laws pertaining to public health and social services, among other things. Existing law also establishes the Inclusion of Women and Minorities in Clinical Research Act, which is designed to promote the inclusion of women and minority groups in clinical research, including clinical trials.
This bill would create the Cancer Clinical Trials Foundation in the Health and Human Services Agency, to be governed by a board of trustees. Members of the board would be appointed as specified. The bill would also create the Cancer Clinical Trials Fund, and would continuously appropriate this fund to the board, thereby making an appropriation. The bill would authorize the board to solicit and receive money, as specified. The bill would require the board, upon contribution of an unspecified amount of money to the fund, to establish the Cancer Clinical Trials Grant Program, in order to increase patient access to cancer clinical trials in specified populations. The bill would require that grant money be used for designated purposes, and would also require grant recipients to report to the board. The bill would require the board to report to the Legislature, as specified. This bill would make related findings.
Vote: majority. Appropriation: yes. Fiscal committee: yes. State-mandated local program: no.
The people of the State of California do enact as follows:
The Legislature finds and declares the following:
2(a) Almost 50 percent of clinical trial studies are not finished
3in time due to low patient participation, recruitment and navigation
4difficulties, and other barriers for patients. Due to economic and
5socioeconomic circumstances and lack of patient knowledge,
6clinical oncology trial participation and retention are both very
7low as they relate to eligible participants.
8(b) Overall, only 3 percent of eligible cancer patients participate
9in clinical trials, and of those only 5 percent of trial participants
10are from racial or ethnic minority
communities.
11(c) One barrier that prevents patients from participating in
12federal Food and Drug Administration clinical trials is finances.
13Patients of low to moderate income are often unable to bear the
14burden of the ancillary costs of participating, such as airfare,
15lodging, rental cars, and fuel.
16(d) The American Medical Association conducted a study on
17cancer trial participation. The study found that from 1996 to 2002,
18of the 75,215 patients enrolled in the National Cancer Institute
19trials for breast, lung, colorectal, and prostate cancers, only 3.1
20percent were Hispanic, 9.2 percent were Black, and 1.9 percent
21were Asian or Pacific Islanders, while 85.6 percent were White.
22This lack of diversity isbegin delete alarmingend deletebegin insert
of concernend insert because of its impact
23on researchers’ ability to evaluate the effect of new treatments on
24different populations. It also speaks to a lack of access to
25potentially lifesaving trials for a large portion of the population.
26(e) It is the intent of the Legislature to establish a program to
27enable willing patients of low to moderate income to participate
28in cancer clinical trials in order to boost participation rates, ensure
P3 1these trials are widely accessible, improve the development of
2cancer therapies, and enhance innovation.
Chapter 2 (commencing with Section 101990) is added
4to Part 6 of Division 101 of the Health and Safety Code, to read:
5
(a) “Board” means the Board of Trustees of the Cancer
9Clinical Trials Foundation.
10(b) “Foundation” means the Cancer Clinical Trials Foundation.
11(c) “Fund” means the Cancer Clinical Trials Fund.
(a) The agency shall establish a nonprofit public
13benefit corporation, to be known as the Cancer Clinical Trials
14Foundation, that shall be governed by a board consisting of a total
15of five members. Three members shall be appointed by the
16Governor. Of these members, one shall be from a public cancer
17research institution, and one shall be from a private cancer research
18institution. One member shall be appointed by the Speaker of the
19Assembly. One member shall be appointed by the President pro
20Tempore of the Senate.
21(b) The Governor shall appoint the president of the board from
22among those members appointed by the Governor, the Speaker of
23the Assembly, and the
President pro Tempore of the Senate.
24(c) The foundation, or an authorized representative thereof,
25shall apply for tax exempt status under Section 501(c)(3) of the
26Internal Revenue Code.
27(c)
end delete
28begin insert(d)end insert Members of the board shall serve without compensation but
29shall be reimbursed for any actual and necessary expenses incurred
30in connection with their duties as members of the board.
31(d)
end delete
32begin insert(e)end insert The foundation shall be subject to the Nonprofit Public
33Benefit Corporation Law (Part 2 (commencing with Section 5110)
34of Division 2 of Title 2 of the Corporationsbegin delete Code), except that if begin insert Code).end insert
35there is a conflict with this chapter and the Nonprofit Public Benefit
36Corporation Law, this chapter shall prevail.end delete
37(e)
end delete
38begin insert(f)end insert The California Health and Human Services Agency shall
39determine which department in the agency shall administer the
40foundation.
(a) Of the members of the board first appointed by
2the Governor pursuant to Section 101991, one member shall be
3appointed to serve a two-year term, one member shall be appointed
4to serve a three-year term, and one member shall be appointed to
5serve a four-year term.
6(b) Of the members of the board first appointed by the Speaker
7of the Assembly and the President pro Tempore of the Senate
8pursuant to Section 101991, each member shall be appointed to
9serve a four-year term.
10(c) Upon the expiration of the initial appointments for the board,
11each member shall be appointed to serve a four-year
term.
(a) There is hereby created the Cancer Clinical Trials
13Fund. Notwithstanding Section 13340 of the Government Code,
14all money in the fund is continuously appropriated to the board
15without regard to fiscal years, for the administration and support
16of the program created pursuant to this chapter.
17(b) The Cancer Clinical Trials Foundation may solicit and
18receive funds from business, industry, foundations, and other
19private and public sources for the purpose of administering the
20Cancer Clinical Trials Grant Program to increase patient access
21to cancer clinical trials.
22(c) The board shall use no more than 20
percent of funds made
23available for the Cancer Clinical Trials Grant Program for
24administrative costs.
(a) Upon contribution of an unspecified amount of
26moneys to the foundation, the board shall establish the Cancer
27Clinical Trials Grant Program to increase patient access to cancer
28clinical trials in underserved or disadvantaged communities and
29populations, including among women and patients from racial and
30ethnic minority communities. The board shall determine the criteria
31to award grants, and may award grants to either or both of the
32following:
33(1) Public and private research institutions and hospitals that
34conduct cancer clinical trials approved by the federal Food and
35Drug Administration.
36(2) Nonprofit organizations described in Section 501(c)(3) of
37the Internal Revenue Code of 1954 that are exempt from income
38tax under Section 501(a) of that code and that specialize in direct
39patient support for improved clinical trial enrollment and retention.
P5 1(b) Grants awarded pursuant to subdivision (a) shall be used for
2activities to increase patient access to cancer clinical trials,
3including, but not limited to, any of the following:
4(1) Patient navigator services or programs.
5(2) Education and community outreach.
6(3) Patient-friendly technical tools to assist patients in
7identifying available clinical trials.
8(4) Translation and interpretation services of clinical trial
9information.
10(5) Counseling services for clinical trial participants.
11(6) Well-being services for clinical trial participants, including,
12but not limited to, physical therapy, pain management, stress
13management, and nutrition management.
14(7) Payment of ancillary costs for patients and caregivers,
15including, but not limited to:
16(A) Airfare during the clinical trial.
17(B) Lodging during the clinical trial.
18(C) Rental cars during the clinical trial.
19(D) Fuel during the clinical trial.
20(E) Local transportation via bus, train, or other public
21transportation during the clinical trial.
22(F) Meals during the clinical trial.
23(G) Child care costs during the clinical trial.
(a) Grant recipients shall report to the board to ensure
25the appropriate use of funds within one year of receiving a grant.
26(b) (1) The board shall report to the Legislature to ensure the
27appropriate use of the funds. The report shall include accountability
28measures, including, but not limited to, a description of how the
29funds were used, an evaluation of the grant program, and
30recommendations for the program. This report shall be submitted
31by January 1, 2020.
32(2) The requirement for submitting a report imposed under
33paragraph (1) is inoperative on January, 1, 2024, pursuant to
34Section
10231.5 of the Government Code.
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