NY State Senate Bill 2009-S4492

Senate Bill S4492

2009-2010 Legislative Session

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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Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 06, 2010	referred to health
Apr 24, 2009	referred to health

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2009-S4492 (ACTIVE) - Details

See Assembly Version of this Bill:: A1805
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §2424, Health L
Versions Introduced in Other Legislative Sessions:: 2011-2012: A807
2013-2014: A2688
2015-2016: A1567
2017-2018: A2538
2019-2020: A1035
2021-2022: A180

2009-S4492 (ACTIVE) - 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.

2009-S4492 (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S4492

 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 : a
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
applicant 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 disabling 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
regulations 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 pediatric enrollees has 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 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
recommended 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 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, 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 facilitate patient navigation, transportation, lodging and patient
and provider education to achieve greater patient participation in
clinical trials.

 PRIOR LEGISLATIVE HISTORY :
2008: A.10624 - Passed the Assembly

 FISCAL IMPLICATIONS :
None - subject to available appropriations.

 EFFECTIVE DATE :
This act shall take effect immediately.

2009-S4492 (ACTIVE) - Bill Text download pdf

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

                                  4492

                       2009-2010 Regular Sessions

                            I N  S E N A T E

                             April 24, 2009
                               ___________

Introduced  by  Sens.  DUANE, HASSELL-THOMPSON -- 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-

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD00367-01-9

S. 4492                             2

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
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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