Amended in Senate August 19, 2016

Amended in Senate August 2, 2016

Amended in Senate June 23, 2016

Amended in Assembly May 27, 2016

Amended in Assembly April 12, 2016

Amended in Assembly March 17, 2016

California Legislature—2015–16 Regular Session

Assembly Bill No. 1823

Introduced by Assembly Member Bonilla

(Principal coauthor: Assembly Member Waldron)

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 an institute or office within the university to administer the 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 to solicit funds from various specified sources for purposes of the program and would require the program administrator, upon receipt 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 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 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 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 finding of the Legislature that some corporations,
individuals, public and private foundations, health care providers,
and other stakeholders are hesitant to contribute to, or accept funds
from, programs that are organized to alleviate financial burdens
faced by patients who wish to participate in clinical trials and their
caregivers, due to concerns that federal regulators would view the
payments made from those funds as prohibited inducements for
patients to receive the health care services provided during clinical
trials.

(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 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. It is the intent of the Legislature that this
program eliminate barriers to the participation of all patients,
regardless of socioeconomic status, in clinical trials.

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.

(c) “Fund” or “clinical trials fund” refers to a fund established
by or on behalf of the program administrator to support the
program.

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

(e) “Program administrator” means the institute or office
designated by the University of California pursuant to 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.

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

101991.  

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

(a) Establish or designate an institute or office within the
university to administer the program.

(b) Establish 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.

(1) The members shall have varying backgrounds to promote
the purposes of this part.

(2) 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.

(3) 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.

(4) 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.

(5) 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.

(6) (A) The program administrator may adjust administrative
costs available for use in the program based on the size of the
program and the funds that are received.

(B) Notwithstanding subparagraph (A), the program
administrator shall use no more than 20 percent of the funds that
are made available for the program for administrative begin delete costs if the
program size and the funds that are received cover the costs of
administering the program. end delete begin insert costs. end insert

begin insert

(C) Notwithstanding subparagraph (B), in the first year of the
program, the program administrator may use more than 20 percent
of the funds for administrative costs, in order to fund the costs of
establishing the program.

end insert

(c) 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.

(d) Publicize the availability of grants made available through
the program to organizations described in subdivision (a) of Section
101994.5.

101992.  

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

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

(a) The program administrator, directly or through a
university-affiliated foundation, may solicit funds from business,
industry, foundations, research organizations, federal government
agencies, individuals, and other private sources for the purpose of
administering the program and awarding grants to increase patient
access to clinical trials targeting cancer, consistent with guidelines
established by the board.

(b) (1) Subject to paragraph (2), only funds from federal or
private sources may be used to administer the program or award
grants.

(2) The university may use its own state source funds for
oversight and administration of the program relating to the initial
start-up costs of the program only, provided the university is
reimbursed from federal or private sources funds.

101993.5.  

Any 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, prior to distribution by the program
of any grants to any entity that is designated under subdivision (a)
of Section 101994.5.

101994.  

Upon the program administrator’s receipt of at least
five hundred thousand dollars ($500,000) in funding for the
program, the program administrator 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.

101994.5.  

(a) The board shall determine the criteria to award
and administer grants to support program grant recipients. 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 that are exempt from taxation 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) Counseling services for clinical trial participants.

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

(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.

(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 program administrator 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) 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
program administrator determines that the 20 percent limit on
administrative costs set forth in subparagraph (B) of paragraph (6)
of subdivision (b) of Section 101991 is inadequate to support the
cost of administering the program authorized pursuant to this part,
the program administrator may elect to dissolve the program.

(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 101994.5.

101997.  

This part does not 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.