BILL NUMBER: S5401
SPONSOR: RIVERA
 
TITLE OF BILL:
An act to amend the public health law, in relation to establishing the
clinical trial access and education fund
 
PURPOSE:
Establishes the clinical trial access and education fund to provide
grants for certain services for patients with life-threatening or disa-
bling conditions/diseases.
 
SUMMARY OF SPECIFIC PROVISIONS:
Section 1 amends the public health law by adding a new section 2424 as
it relates to the establishment of the Clinical Trial Access and Educa-
tion Fund. Subdivision 1 of this legislation provides definitions for
the following terms: (a) "eligible applicant", (b) "clinical trial", and
( c) "ancillary costs."
Subdivision 2 establishes the clinical trial access and education fund
within the Department of Health (DOH) to provide grants to eligible
applicants on a competitive request for proposal basis to provide
certain services to patients with life-threatening or disabling condi-
tions or diseases as defined in statute, to facilitate access to or
education on clinical trials of treatments for the patient's condition
or disease. Such services would include: transportation and lodging to
patients so they may access a clinical trial or related treatment;
patient outreach and education on the existence of and how to enroll in
clinical trials; and patient navigation services to help patients deter-
mine eligibility for clinical trials.
Subdivision 3 requires the Commissioner of Health (COH) to establish an
application process for eligible applicants. Applications would include:
the geographic area in which services will be provided, a description of
the services provided, the applicant's experience in working with
patients who have life-threatening or disabling conditions or diseases,
the applicant's ability to provide patient outreach or clinical trial
education and navigation services or coordinate transportation or lodg-
ing for patients, and any other information deemed appropriate. Provides
for the eligibility of applicants to include experience working with
patients with life-threatening or disabling conditions; the ability to
provide patient outreach, education, and healthcare navigation services;
collaborate with physicians, healthcare providers, and clinical trial
sponsors to notify a prospective subject about the program when appro-
priate, among other criteria; and reimburse subjects based on financial
needs.
Subdivision 4 establishes the institutional review board requirements
associated with the clinical trial. A reimbursement program under this
section would be approved by the institutional review board associated
with the trial and comply with applicable federal and state laws.
Subdivision 5 provides that reimbursement of ancillary costs under the
program would not constitute an undue inducement to participate in the
trial or be considered coercion or exertion of undue influence to
participate, and is meant to accomplish parity in trials and remove
barriers to participation.
Subdivision 6 provides for reporting requirements, requiring grantees to
file reports annually with the COH detailing the expenditure of grant
funds, and the efforts taken to increase patient access to clinical
trials.
Subdivision 7 provides that the COH would develop regulations necessary
to implement this section.
Section 2 provides the effective date.
 
JUSTIFICATION:
New therapies to treat cancer and other life-threatening diseases are
being developed at an increasing pace. Clinical trials are the most
effective method of determining the benefits of experimental treatments
and are critical to improving health care and mortality rates for
patients with cancer and other life-threatening diseases.
A large number of pediatric enrollees in clinical trials led to the
discovery of groundbreaking therapies and a survival rate of over 80%
for childhood cancer. To achieve a similar rate of success for adults
with cancer and other diseases, information and access to clinical
trials must be made more widely available to patients and their treating
health care providers.
A number of studies have looked at the reasons for low adult patient
participation in clinical trials. One such study conducted by the
University of California Davis' Cancer Center surveyed patients and
physicians about clinical trial participation. Of the 276 patients
surveyed, only 76 said they would participate in clinical trials if
recommended by their physician. Of this, only 39 actually enrolled.
The two most common reasons why patients declined to participate were
related to a desire for other treatments and the distance to the cancer
center. The study authors made a series of recommendations to overcome
these barriers including the need for greater physician and patient
education on the status, availability, and benefits of clinical trials,
as well as the need to address geographical issues that serve as strong
deterrents to clinical trial access.
The Clinical Trial Access and Education Fund will address these major
barriers identified by the clinical research and anecdotally from
patients and providers in New York by providing grants to not-for-profit
community groups, health care provider associations, and research
centers that conduct clinical trials so they may provide and/or facili-
tate patient navigation, transportation, lodging, and patient and
provider education to achieve greater patient participation in clinical
trials.
 
LEGISLATIVE HISTORY:
2013-2014: S6442 Rivera/A2688 Gottfried
2015-2016: S777 Rivera/A1567 Gottfried
2017-2018: S1216 Rivera/A2538 Gottfried
2019-2020: S932Rivera/A1035 Gottfried
2021-2022: S1169-A Rivera/A180-A Gottfried
2023-2024: S4793 Rivera/No Same As
 
FISCAL IMPLICATIONS:
None, subject to available appropriations.
 
EFFECTIVE DATE:
Effective immediately.