Bill Text: CA AB1823 | 2015-2016 | Regular Session | Chaptered
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-Chaptered.html
BILL NUMBER: AB 1823 CHAPTERED
BILL TEXT
CHAPTER 661
FILED WITH SECRETARY OF STATE SEPTEMBER 26, 2016
APPROVED BY GOVERNOR SEPTEMBER 26, 2016
PASSED THE SENATE AUGUST 23, 2016
PASSED THE ASSEMBLY AUGUST 29, 2016
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
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, 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.
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 costs.
(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.
(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.
