senate Bill S6442

Establishes the clinical trial access and education fund to provide grants for certain services for patients with life-threatening or disabling conditions/diseases

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Bill Status


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor
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actions

  • 24 / Jan / 2014
    • REFERRED TO HEALTH

Summary

Establishes the clinical trial access and education fund to provide grants to eligible applicants to provide certain services for patients with life-threatening or disabling conditions or diseases.

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Bill Details

See Assembly Version of this Bill:
A2688
Versions:
S6442
Legislative Cycle:
2013-2014
Current Committee:
Senate Health
Law Section:
Public Health Law
Laws Affected:
Add §2424, Pub Health L
Versions Introduced in Previous Legislative Cycles:
2011-2012: A807, A807
2009-2010: A1805, A1805
2007-2008: A10624, A10624

Sponsor Memo

BILL NUMBER:S6442

TITLE OF BILL: An act to amend the public health law, in relation to
establishing the clinical trial access and education fund

PURPOSE OR GENERAL IDEA OF BILL:

This bill creates the Clinical Trial Access and Education Fund, a state
grant program within the department to provide funding to address the
major barriers to participation in clinical trials in New York State.

SUMMARY OF SPECIFIC PROVISIONS:

Section 1 amends article 24 of the public health law by adding a new
section 2424, the Clinical Trial Access and Education Fund.

Subdivision 1 of the new section provides definitions of eligible appli-
cant and clinical trial.

Subdivision 2 establishes the clinical trial access and education fund
within the department to provide grants to eligible applicants on a
competitive request for proposal basis to provide certain services to
patients with life-threatening or disabling conditions or diseases.
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 determine eligibility
for clinical trials.

Subdivision 3 establishes an application process for eligible applicants
and states that the commissioner shall give Preference to applicants who
have experience and expertise providing patient outreach, education,
navigation and other services to patients with life-threatening or disa-
bling conditions or diseases.

Subdivision 4 requires grantees to file an annual report with the
commissioner summarizing how they utilized the grant funds to increase
patient access to clinical trials.

Subdivision 5 requires the commissioner to make any necessary regu-
lations to implement the section.

Section 2 establishes 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, scientifically valid method of determining the benefits of
experimental treatments. They are critical to improving health care and
mortality rates for patients with cancer and other life-threatening
diseases.

While fewer than 5% of adult cancer patients participate in clinical
trials, 60% of pediatric cancer patients do. This large number of pedia-
tric enrollees has led to the discovery of groundbreaking therapies and
a survival rate of over 8O% 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 recent study conducted by the
University of California Davis Cancer Center surveyed oncologists
regarding patient and physician decision-making about participation in
clinical trials. Of the 276 patients assessed, oncologists only recom-
mended that 76 patients participate in clinical trials and only 39
patients or 14% actually enrolled in the trials. The two most common
reasons that patients cited for declining to participate were a desire
for other treatment and the distance from 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 clin-
ical 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, it will provide grants to non-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 provid-
er education to achieve greater patient participation in clinical
trials.

PRIOR LEGISLATIVE HISTORY:

2009; A.1805 - passed Assembly
2010: A.1805 - passed Assembly
2011-12: A.807 - passed Assembly

FISCAL IMPLICATIONS:

None - subject to available appropriations.

EFFECTIVE DATE:

This act shall take effect immediately.

view bill text
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  6442

                            I N  S E N A T E

                            January 24, 2014
                               ___________

Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health

AN ACT to amend the public health law, in relation to  establishing  the
  clinical trial access and education fund

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. The public health law is amended by adding  a  new  section
2424 to read as follows:
  S 2424. CLINICAL TRIAL ACCESS AND EDUCATION FUND. 1. DEFINITIONS.  FOR
THE PURPOSES OF THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE FOLLOW-
ING MEANINGS:
  A.  "ELIGIBLE  APPLICANT"  MEANS  (I) A MEDICAL SCHOOL THAT SPONSORS A
CLINICAL TRIAL, (II) A NOT-FOR-PROFIT ORGANIZATION WITH  EXPERIENCE  AND
EXPERTISE  WORKING  WITH  PATIENTS  WITH  LIFE-THREATENING  OR DISABLING
CONDITIONS OR DISEASES, (III) A HEALTH CARE PROVIDER ORGANIZATION, ASSO-
CIATION  OR  SOCIETY,  (IV)  A  GENERAL  HOSPITAL  DEFINED  IN   ARTICLE
TWENTY-EIGHT OF THIS CHAPTER, (V) A COUNTY OR CITY HEALTH DEPARTMENT, OR
(VI) A MUNICIPALITY.
  B.  "CLINICAL  TRIAL"  SHALL  HAVE  THE SAME MEANING AS IN SUBDIVISION
TWO-B OF SECTION FORTY-NINE HUNDRED OF THIS CHAPTER.
  2. ESTABLISHMENT OF FUND.  THERE  IS  HEREBY  ESTABLISHED  WITHIN  THE
DEPARTMENT A CLINICAL TRIAL ACCESS AND EDUCATION FUND. SUBJECT TO APPRO-
PRIATIONS, THE DEPARTMENT SHALL PROVIDE GRANTS TO ELIGIBLE APPLICANTS ON
A  COMPETITIVE  REQUEST FOR PROPOSAL BASIS TO PROVIDE ONE OR MORE OF THE
FOLLOWING SERVICES TO PATIENTS WITH LIFE-THREATENING OR DISABLING CONDI-
TIONS OR DISEASES, AS SUCH  TERMS  ARE  DEFINED  IN  SECTION  FORTY-NINE
HUNDRED  OF  THIS CHAPTER, TO FACILITATE ACCESS TO OR EDUCATION ON CLIN-
ICAL TRIALS OF TREATMENTS FOR THE PATIENT'S CONDITION OR DISEASE:
  A. TRANSPORTATION SERVICES AND LODGING TO PROVIDE PATIENTS WITH ACCESS
TO CLINICAL TRIALS OR OTHER RELATED TREATMENTS WHILE ENROLLED IN A CLIN-
ICAL TRIAL OR TO ACCESS TESTING AND OTHER SERVICES TO DETERMINE  PATIENT
ELIGIBILITY FOR A CLINICAL TRIAL;
  B.  PATIENT OUTREACH AND EDUCATION SERVICES TO EDUCATE PATIENTS, THEIR
FAMILIES AND HEALTH CARE  PROVIDERS  ABOUT  THE  EXISTENCE  OF  AND  HOW

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD01585-01-3

S. 6442                             2

PATIENTS  MAY ENROLL IN CLINICAL TRIALS, UNDER SECTION TWO HUNDRED SEVEN
OF THIS CHAPTER; AND
  C.  PATIENT  NAVIGATION SERVICES TO HELP PATIENTS TO DETERMINE IF THEY
ARE ELIGIBLE FOR CLINICAL TRIALS, TO HELP PATIENTS TO ENROLL IN CLINICAL
TRIALS AND TO ASSIST PATIENTS IN DEALING WITH INSURANCE OR OTHER  ISSUES
WHICH SERVE AS BARRIERS TO PATIENT ENROLLMENT IN CLINICAL TRIALS.
  3. APPLICATIONS. THE COMMISSIONER SHALL ESTABLISH AN APPLICATION PROC-
ESS  BY  WHICH  ELIGIBLE  APPLICANTS  MAY  APPLY  FOR A GRANT UNDER THIS
SECTION.  THE APPLICATION SHALL INCLUDE:
  A. THE GEOGRAPHIC AREA IN WHICH THE SERVICES SHALL BE PROVIDED;
  B. A DETAILED DESCRIPTION OF THE SERVICES TO BE PROVIDED;
  C. APPLICANT'S EXPERIENCE WORKING WITH PATIENTS WITH  LIFE-THREATENING
OR DISABLING CONDITIONS OR DISEASES;
  D.  APPLICANT'S  ABILITY TO PROVIDE PATIENT OUTREACH OR CLINICAL TRIAL
EDUCATION AND NAVIGATION SERVICES, OR COORDINATE OR PROVIDE  TRANSPORTA-
TION AND LODGING FOR PATIENTS; AND
  E.  ANY  OTHER  INFORMATION  THAT  THE COMMISSIONER DEEMS RELEVANT AND
APPROPRIATE.
  THE COMMISSIONER SHALL GIVE PREFERENCE TO ELIGIBLE APPLICANTS WHO HAVE
EXPERIENCE AND EXPERTISE WORKING WITH PATIENTS WITH LIFE-THREATENING  OR
DISABLING  CONDITIONS OR DISEASES AND PROVIDING PATIENT OUTREACH, EDUCA-
TION AND HEALTH CARE NAVIGATION SERVICES.
  4. REPORTS. GRANTEES SHALL FILE AN ANNUAL REPORT WITH THE  COMMISSION-
ER,  IN SUCH FORM AND WITH SUCH INFORMATION AND DATA AS THE COMMISSIONER
PRESCRIBES DETAILING THE EXPENDITURE OF GRANT FUNDS AND SUMMARIZING  THE
EFFORTS UNDERTAKEN TO INCREASE PATIENT ACCESS TO CLINICAL TRIALS.
  5.  THE  COMMISSIONER  SHALL  MAKE REGULATIONS REASONABLY NECESSARY TO
IMPLEMENT THE PROVISIONS OF THIS SECTION.
  S 2. This act shall take effect immediately.

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