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  APRIL 12, 2016
	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  establish or  designate  a nonprofit
organization as   an institute or office within the
university to administer  the  program administrator
  program, which would be  governed by a board of
at least 5 members appointed by the president of the university. The
bill would authorize the  program administrator 
 board  to solicit  and receive  funds from
various specified sources for purposes of the program and would
require the board, upon receipt  by the program administrator
 of at least $500,000 in funding, to establish 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  the 2016 report of the  Public Policy
Institute of  California's Future: Health Care report
released in 2015,   California entitled California's
Future: Health Care,  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,
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, 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.   Institute.

   (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   10 
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.  
   (g) It is the finding of the Legislature that some corporations,
individuals, public and private foundations, and other stakeholders
are hesitant to contribute to, or accept funds from, programs that
are organized to alleviate financial burdens, and that there are
disincentives faced by patients who wish to participate in clinical
trials and their caregivers.  
   (h) It is the intent of the Legislature to enact legislation that
would establish a program to authorize business, industry, public and
private foundations, individuals, and other stakeholders to donate
to the program described in this act, as well as to other nonprofit
corporations and public charities that specialize in the enrollment,
retention, and increased participation of patients in cancer clinical
trials.  
   (i) It is the intent of the Legislature to enact legislation that
would establish a program to better enable donors willing to assist
clinical research participants from communities that have documented
low levels of access to health services or participation in clinical
trials, face financial barriers to participation in clinical trials,
or have been identified as priorities for health services, to
participate in clinical trials by supporting ancillary costs to boost
participation rates among the research participant populations,
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 
shall  apply:
   (a) "Board" means the Board of Trustees of the California Cancer
Clinical Trials Program. 
   (b) "Eligible cancer clinical trial" means a clinical trial, as
defined in Section 300gg-8(d) of Title 42 of the United States Code,
that is conducted in the state, that targets cancer, and that is
regulated by the United States Food and Drug Administration. 

   (b) 
    (c)  "Fund" or "clinical trials fund" refers to a fund
established by  or on behalf of  the Program
Administrator   program administrator  to support
the program. 
   (c) 
    (d)  "Program" means the California Cancer Clinical
Trials Program. 
   (d) 
    (e)  "Program administrator" means the 
nonprofit organization   institute or office 
designated by the University of California pursuant to paragraph (1)
of subdivision (a) of Section 101991. 
   (f) "Program grant recipient" means an organization that receives
support from the fund to carry out the purposes of this part. 

   (e) 
    (g)  "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 2 (commencing with Section 5110) of Division 2 of Title 1
of the Corporations Code)   or designate an institute or
office within the university  to administer the program.
   (2) Establish  a governing board of the program
administrator consisting   the board, to consist 
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. 
   (A) The members shall have varying backgrounds to promote the
purposes of this part.  
   (B) The board shall be qualified through the experience,
expertise, and diversity of its members in the design,
implementation, and support of clinical trials, and through studying
and addressing socioeconomic, ethnic or racial, regional, and other
barriers to participation and interventions to remove those barriers.
 
   (C) Efforts shall be made to include representatives of a range of
public and private research institutions, health care providers,
health care foundations, and patient advocacy organizations. 

   (3) Publicize to National Cancer Institute-Designated Cancer
Centers, community organizations, hospitals, hospital associations,
industry, health care foundations, and government agencies, the
opportunity to submit nominations for board membership to the
president of the university.  
   (4) Publicize the availability of grants made available through
the program to organizations described in subdivision (a) of Section
101994.5. 
   (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. 
   (d) (1) The board may adjust administrative costs available for
use in the program based on the size of the program and the funds
that are received.  
   (2) Notwithstanding paragraph (1), the board shall use no more
than 20 percent of the funds that are made available for the program
for administrative costs if the program size and the funds that are
received cover the costs of administering the program. 
   101992.  (a) The university may participate in the program as the
program administrator, a beneficiary, or both.
   (b) Prior to establishing the  board,  
program,  the university may pursue any federal, state, or
internal approvals, authorizations, or advice it deems necessary to
the university's  participation in the program. 
 participation. 
   (c) The university may decline to establish or participate in the
program. 
   (d) The university may terminate the program if it determines that
the program is not viable. 
   101993.  The  program administrator  board
 may  directly or through a university-affiliated foundation
 solicit  and receive  funds  on behalf of
the program administrator  from business, industry,
foundations, research organizations, government agencies,
individuals, and other private and public sources for the purpose of
administering the program  and awarding grants  to increase
patient access to clinical trials targeting cancer.
   101993.5.  Any  money   funds, personnel,
facility, equipment, or other resources that are  allocated by
the university to establish and operate the program shall be
reimbursed to the university, from moneys donated to the 
fund.   fund, prior to distribution by the program of
any grants to any entity that is designated under subdivision (a) of
Section 101994.5. 
   101994.   (a)    Upon  the
program administrator's  receipt of at least five hundred
thousand dollars ($500,000) in funding for the  program by
the program administrator,   program,  the board
shall establish  the fund and  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 
    101994.5.    (a)     The 
board shall determine the criteria to award  and administer 
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  
that are exempt from taxati   on under  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 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) 
    (4)  Counseling services for clinical trial
participants. 
   (6) 
    (5)  Well-being services for clinical trial
participants, including, but not limited to, physical therapy, pain
management, stress management, and nutrition management. 
   (7) 
    (6)  Payment of ancillary costs for patients and
caregivers, including, but not limited 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) 
    (7)  Research on the effectiveness of these and other
measures to increase patient access to clinical trials. 
   (c) When determining program grant recipients pursuant to
subdivision (a), the board is encouraged to grant special
consideration to public or nonprofit applicants that provide patient
services related to cancer clinical trials that address health
disparities or that possess two or more years' experience in the
improvement of enrollment, retention, or participation in cancer
clinical trial participation with an emphasis on underserved
populations. 
   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 program's and  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.
   (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. 
   (b) If the fund does not receive five hundred thousand dollars
($500,000) or more by January 1, 2021, or, if at any time, the board
determines that the 20 percent limit on administrative costs set
forth in paragraph (2) of subdivision (d) of Section 101991 is
inadequate to support the cost of administering the program
authorized pursuant to this part, moneys remaining after the
repayment required pursuant to Section 101993.5 shall be returned to
the donors on a pro rata basis.  
   (2) 
    (c)  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.   101994.5. Moneys remaining after the repayment
required pursuant to Section 101993.5   shall be returned
to the donors on a pro rata basis, or, at the donor's direction,
redirected to one or more organizations that are described in
subdivision (a) of Section 101994.5.  
   (b) If the fund does not receive five hundred thousand dollars
($500,000) or more by January 1, 2021, moneys remaining after the
repayment required pursuant to Section 101993.5 shall be returned to
the donors on a pro rata basis.  
   101997.  Nothing in this part shall preclude the university from
establishing or operating one or more similar programs to facilitate
participation in any clinical trials, as defined in Section 300gg-8
(d) of Title 42 of the United States Code.