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

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

(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 begin delete ten end delete begin insert 10 end insert 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.

begin delete

(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.

end delete begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert

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
begin insert shall end insert apply:

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

begin insert

(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.

end insert begin delete

(b)

end delete

begin insert (c) end insert  “Fund” or “clinical trials fund” refers to a fund established
by begin insert or on behalf of end insert the begin delete Program Administrator end delete begin insert program
administrator end insert to support the program.

begin delete

(c)

end delete

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

begin delete

(d)

end delete

begin insert (e) end insert  “Program administrator” means the begin delete nonprofit organization end delete
begin insert institute or office end insert designated by the University of California
pursuant to paragraph (1) of subdivision (a) of Section 101991.

begin insert

(f) “Program grant recipient” means an organization that
receives support from the fund to carry out the purposes of this
part.

end insert begin delete

(e)

end delete

begin insert (g) end insert  “University” means the University of California.

begin delete

(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.

end delete

101991.  

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

(1) Establish begin delete 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) end delete begin insert or designate an institute or office
within the university end insert to administer the program.

(2) Establish begin delete a governing board of the program administrator
consisting end delete begin insert the board, to consist end insert 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.

begin insert

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

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

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

end insert

(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.

begin insert

(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.

end insert begin insert

(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.

end insert

101992.  

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

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

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

begin insert

(d) The university may terminate the program if it determines
that the program is not viable.

end insert

101993.  

The begin delete program administrator end delete begin insert board end insert may begin insert directly or
through a university-affiliated foundation end insert solicit begin delete and receive end delete funds
begin insert on behalf of the program administrator end insert from business, industry,
foundations, research organizations, government agencies,
individuals, and other private and public sources for the purpose
of administering the program begin insert and awarding grants end insert to increase
patient access to clinical trials targeting cancer.

101993.5.  

Any begin delete money end delete begin insert funds, personnel, facility, equipment,
or other resources that are end insert allocated by the university to establish
and operate the program shall be reimbursed to the university,
from moneys donated to the begin delete fund. end delete begin insert fund, prior to distribution by
the program of any grants to any entity that is designated under
subdivision (a) of Section 101994.5. end insert

101994.  

begin delete (a) end delete begin delete   end delete Upon begin insert the program administrator’s end insert receipt of at
least five hundred thousand dollars ($500,000) in funding for the
begin delete program by the program administrator, end delete begin insert program, end insert the board shall
establish begin insert the fund and end insert 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. begin delete The end delete

begin insert

begin insert 101994.5. end insert   

end insert

begin insert (a) end insert begin insert   end insert begin insert The end insert board shall determine the criteria to award
begin insert and administer end insert 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 begin delete described in end delete begin insert that are exempt from
taxation under end insert Section 501(c) of the Internal Revenue Code begin insert and end insert
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.

begin delete

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

end delete begin delete

(5)

end delete

begin insert (4) end insert  Counseling services for clinical trial participants.

begin delete

(6)

end delete

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

begin delete

(7)

end delete

begin insert (6) end insert  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.

begin delete

(8)

end delete

begin insert (7) end insert  Research on the effectiveness of these and other measures
to increase patient access to clinical trials.

begin insert

(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.

end insert

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 begin insert the program’s and end insert 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)  begin delete (1) end delete begin delete   end delete 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.

begin insert

(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.

end insert begin delete

(2)

end delete

begin insert (c) end insert  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 begin delete 101994. end delete begin insert 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. end insert

begin delete

(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.

end delete

begin insert

begin insert 101997. end insert   

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.

end insert