Bill Text: CA AB1823 | 2015-2016 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: California Cancer Clinical Trials Program.

Spectrum: Bipartisan Bill

Status: (Passed) 2016-09-26 - Chaptered by Secretary of State - Chapter 661, Statutes of 2016. [AB1823 Detail]

Download: California-2015-AB1823-Amended.html

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BILL NUMBER: AB 1823	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MARCH 17, 2016

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  would  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   require  the board, upon
receipt of at least $500,000 in funding, to establish 
program   the Cancer Clinical Trials Grant 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:

  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,
 childcare,   child care,  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,  Irvine  
Irvine,  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  1   2  (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  and   that  do
either of the following:
   (A) Specialize in direct patient support for improved clinical
trial enrollment and retention.
   (B) Engage in research on health  disparities. 
 disparities and their relationship to clinical trial enrollment.

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