Amended in Assembly March 17, 2016

California Legislature—2015–16 Regular Session

Assembly Bill No. 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 amended, 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 begin insert would end insert 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 begin delete authorize end delete begin insert require end insert the board, upon receipt of at least $500,000 in funding, to establish begin delete program end delete begin insert the Cancer Clinical Trials Grant Program end insert 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:

SECTION 1.  

The Legislature finds and declares all of the
following:

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

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

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

(1) University of California, begin delete Irvine end delete begin insert Irvine, end insert Chao Family
Comprehensive Cancer Center.

(2) City of Hope Comprehensive Cancer Center.

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

(4) Salk Institute Cancer Center.

(5) Sanford Burnham Prebys Medical Discovery Institute.

(6) Stanford Cancer Center.

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

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

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

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

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

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

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

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

SEC. 2.  

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

 

PART 7.  California Cancer Clinical Trials
Program

 

101990.  

For purposes of this part, the following definitions
apply:

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

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

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

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

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

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

101991.  

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

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

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

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

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

101992.  

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

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

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

101993.  

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

101993.5.  

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

101994.  

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

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

(2) Nonprofit organizations described in Section 501(c) of the
Internal Revenue Code begin delete and end delete begin insert that end insert do either of the following:

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

(B) Engage in research on health begin delete disparities. end delete begin insert disparities and
their relationship to clinical trial enrollment. end insert

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

(1) Patient navigator services or programs.

(2) Education and community outreach.

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

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

(5) Counseling services for clinical trial participants.

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

(7) Payment of ancillary costs for patients and caregivers,
including, but not limited begin delete to end delete begin insert to, end insert all of the following during and
related to participation in the clinical trial:

(A) Airfare.

(B) Lodging.

(C) Rental automobile and fuel for the automobile.

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

(E) Meals.

(F) Dependent child care.

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

101995.  

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

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

(1) An accounting of funds collected and expended.

(2) An evaluation of the program.

begin delete

(c)

end delete

begin insert (3) end insert  Recommendations regarding the program.

101996.  

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

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

(b) If the begin delete foundation end delete begin insert fund end insert does not receive five hundred thousand
dollars ($500,000) or more by January 1, 2021, moneys remaining
after the repayment required pursuant to begin delete subdivision (a) of end delete Section
101993.5 shall be returned to the donors on a pro rata basis.