California Legislature—2015–16 Regular Session

Assembly BillNo. 1823


Introduced by Assembly Member Bonilla

February 8, 2016


An act to add Part 7 (commencing with Section 101990) to Division 101 of the Health and Safety Code, relating to clinical trials.

LEGISLATIVE COUNSEL’S DIGEST

AB 1823, as introduced, Bonilla. California Cancer Clinical Trials Program.

Existing law, the Inclusion of Women and Minorities in Clinical Research Act, requires a grantee, defined to include, but not be limited to, a college or university that conducts clinical research using state funds, to ensure that women and minority groups are included as subjects in each research project, except as provided. Existing law establishes the University of California.

This bill would provide for the establishment of the California Cancer Clinical Trials Program and request that the University of California designate a nonprofit organization as the program administrator governed by a board of at least 5 members appointed by the president of the university. The bill would authorize the program administrator to solicit and receive funds from various specified sources for purposes of the program and would authorize the board, upon receipt of at least $500,000 in funding, to establish program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, as specified.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

P2    1

SECTION 1.  

The Legislature finds and declares all of the
2following:

3(a) According to Public Policy Institute of California’s Future:
4Health Care report released in 2015, significant health disparities
5exist among socioeconomic, racial, ethnic, and regional groups in
6California. African Americans and persons with a high school
7education or less have significantly lower life expectancies than
8other groups of people, and individuals in some regions of the state
9or in particular communities face other significant health obstacles.

10(b) The ability to translate medical findings from research to
11practice relies largely on having robust patient participation and
12a diverse participation pool. A low participation rate or a
13homogenous participant group prevents segments of the population
14from benefiting from advances achieved through clinical research
15and creates uncertainties over the applicability of research findings.
16Diverse patient participation in a clinical trial depends, in part, on
17whether a participant can afford ancillary costs like transportation,
18childcare, or lodging during the course of his or her participation.
19A national study in 2015 found that patient households making
20less than $50,000 annually were almost 30 percent less likely to
21participate in clinical trials. This disparity threatens one of the
22most basic ethical underpinnings of clinical research, the
23requirement that the benefits of research be made available
24equitably among all eligible individuals.

25(c) California is home to the following 10 National Cancer
26Institute-Designated Cancer Centers that perform cancer clinical
27trials research:

28(1) University of California, Irvine Chao Family Comprehensive
29Cancer Center.

30(2) City of Hope Comprehensive Cancer Center.

31(3) University of California, Los Angeles, Jonsson
32Comprehensive Cancer Center.

33(4) Salk Institute Cancer Center.

34(5) Sanford Burnham Prebys Medical Discovery Institute.

35(6) Stanford Cancer Center.

36(7) University of California, Davis, Comprehensive Cancer
37Center.

38(8) University of California, San Diego, Moores Cancer Center.

P3    1(9) University of California, San Francisco, Helen Diller Family
2Comprehensive Cancer Center.

3(10) University of Southern California, Norris Comprehensive
4Cancer Center.

5(d) Cancer is the cause of almost one in four deaths in California.
6It is the second leading cause of death for Californians and the
7primary cause of death among Californian Asian/Pacific Islanders.
8A Californian will be diagnosed with cancer approximately every
9four minutes, and every ten minutes a Californian will die of
10cancer. African American Californians in particular face
11disproportionally higher rates of cancer incidence and mortality
12compared to other races and ethnicities.

13(e) Addressing barriers faced by medically underserved and
14underrepresented individuals in cancer and other clinical trials and
15improving access to survivorship resources and services through
16partnerships with hospitals, regional and community cancer centers,
17and nonprofit organizations are some of the strategies
18recommended by the California Dialogue on Cancer, established
19in 2002 by California’s Comprehensive Cancer Control Program
20to reduce the burden of cancer in California.

21(f) According to the National Cancer Institute Cancer Clinical
22Trials Resource Guide, some of the barriers preventing individuals
23with cancer or at high risk of developing cancer from participating
24in clinical trials are direct and indirect financial and personal costs,
25including travel and child care expenses.

26(g) It is the intent of the Legislature to enact legislation that
27would establish a program to enable willing patients of low to
28moderate income to participate in cancer and other clinical trials
29in order to boost participation rates, ensure these trials are widely
30accessible, improve the development of therapies, and enhance
31innovation.

32

SEC. 2.  

Part 7 (commencing with Section 101990) is added to
33Division 101 of the Health and Safety Code, to read:

34 

35PART 7.  California Cancer Clinical Trials
36Program

37

 

38

101990.  

For purposes of this part, the following definitions
39apply:

P4    1(a) “Board” means the Board of Trustees of the California
2Cancer Clinical Trials Program.

3(b) “Fund” or “clinical trials fund” refers to a fund established
4by the Program Administrator to support the program.

5(c) “Program” means the California Cancer Clinical Trials
6Program.

7(d) “Program administrator” means the nonprofit organization
8designated by the University of California pursuant to paragraph
9(1) of subdivision (a) of Section 101991.

10(e) “University” means the University of California.

11(f) “Eligible cancer clinical trial” means a clinical trial conducted
12in the state that targets cancer and is regulated by the federal Food
13and Drug Administration.

14

101991.  

(a) The university is hereby requested to do all of the
15following:

16(1) Establish and designate, or designate, a nonprofit
17organization, governed by the Nonprofit Public Benefit Corporation
18Law (Part 1 (commencing with Section 5110) of Division 2 of
19Title 1 of the Corporations Code) to administer the program.

20(2) Establish a governing board of the program administrator
21consisting of at least five members, appointed by the president of
22the university to represent institutions and individuals performing,
23participating in, and supporting eligible cancer clinical trials in
24California.

25(b) All persons appointed to the board shall have an interest in
26increasing and diversifying access to eligible cancer clinical trials
27and the ability and desire to solicit funds for the purpose of
28increasing and diversifying access to clinical trials as provided in
29this part.

30(c) Members of the board shall serve without compensation. A
31board member shall be reimbursed for any actual, necessary, and
32reasonable expenses incurred in connection with his or her duties
33as a board member.

34

101992.  

(a) The university may participate in the program as
35the program administrator, a beneficiary, or both.

36(b) Prior to establishing the board, the university may pursue
37any federal, state, or internal approvals, authorizations, or advice
38it deems necessary to the university’s participation in the program.

39(c) The university may decline to establish or participate in the
40program.

P5    1

101993.  

The program administrator may solicit and receive
2funds from business, industry, foundations, research organizations,
3government agencies, individuals, and other private and public
4sources for the purpose of administering the program to increase
5patient access to clinical trials targeting cancer.

6

101993.5.  

Any money allocated by the university to establish
7and operate the program shall be reimbursed to the university,
8from moneys donated to the fund.

9

101994.  

(a) Upon receipt of at least five hundred thousand
10dollars ($500,000) in funding for the program by the program
11administrator, the board shall establish the Cancer Clinical Trials
12Grant Program to increase patient access to eligible cancer clinical
13trials in underserved or disadvantaged communities and
14populations, including among women and patients from racial and
15ethnic minority communities and socioeconomically disadvantaged
16communities. The board shall determine the criteria to award grants
17to support cancer clinical trials. The board may award grants to
18any or all of the following:

19(1) Public and private research institutions and hospitals that
20conduct eligible cancer clinical trials.

21(2) Nonprofit organizations described in Section 501(c) of the
22Internal Revenue Code and do either of the following:

23(A) Specialize in direct patient support for improved clinical
24trial enrollment and retention.

25(B) Engage in research on health disparities.

26(b) Grants awarded pursuant to subdivision (a) shall be used for
27activities to increase patient access to eligible cancer clinical trials,
28including, but not limited to, any of the following:

29(1) Patient navigator services or programs.

30(2) Education and community outreach.

31(3) Patient-friendly technical tools to assist patients in
32identifying available clinical trials.

33(4) Translation and interpretation services of clinical trial
34information.

35(5) Counseling services for clinical trial participants.

36(6) Well-being services for clinical trial participants, including,
37but not limited to, physical therapy, pain management, stress
38management, and nutrition management.

P6    1(7) Payment of ancillary costs for patients and caregivers,
2including, but not limited to all of the following during and related
3to participation in the clinical trial:

4(A) Airfare.

5(B) Lodging.

6(C) Rental automobile and fuel for the automobile.

7(D) Local public transportation by bus, train, or other public
8transportation.

9(E) Meals.

10(F) Dependent child care.

11(8) Research on the effectiveness of these and other measures
12to increase patient access to clinical trials.

13

101995.  

(a) The board shall require grantees to submit any
14reports it deems necessary to ensure the appropriate use of funds
15consistent with the purposes of this part and the terms of any grant
16awards.

17(b) The university may require the board to submit reports
18pertaining to the board’s activities to the Regents of the University
19of California, including, but not limited to, the following
20information:

21(1) An accounting of funds collected and expended.

22(2) An evaluation of the program.

23(c) Recommendations regarding the program.

24

101996.  

(a) (1) If the university determines at any time that
25the moneys in the fund are insufficient to establish or sustain the
26program, the university may terminate the program.

27(2) All moneys in the fund remaining after expenses are paid
28shall, prior to dissolution, be allocated to one or more organizations
29described in subdivision (a) of Section 101994.

30(b) If the foundation does not receive five hundred thousand
31dollars ($500,000) or more by January 1, 2021, moneys remaining
32after the repayment required pursuant to subdivision (a) of Section
33101993.5 shall be returned to the donors on a pro rata basis.



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