NY State Senate Bill 2021-S8190

Senate Bill S8190

2021-2022 Legislative Session

Requires clinical trials that apply for state grant funding to make certain information about such clinical trials public

download bill text pdf

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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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Feb 01, 2022	referred to health

co-Sponsors

2021-S8190 (ACTIVE) - Details

See Assembly Version of this Bill:: A9331
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add Art 2 Title 8 §§269 - 269-b, Pub Health L
Versions Introduced in 2023-2024 Legislative Session:: S1523, A8197

2021-S8190 (ACTIVE) - Summary

Requires any sponsor of a clinical trial in this state, including but not limited to, a pharmaceutical drug manufacturer, pharmaceutical drug wholesaler, academic medical center, voluntary group, federal agency or health care provider, that applies for a state grant to conduct such clinical trial, to conspicuously post certain information about such clinical trial on the department's website.

2021-S8190 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S8190

SPONSOR: PERSAUD
 
TITLE OF BILL:

An act to amend the public health law, in relation to requiring clinical
trials that apply for state grant funding to make certain information
about such clinical trials public

 
PURPOSE OR GENERAL IDEA OF BILL:

This bill requires clinical trials that apply for state grant funding to
make certain information about such clinical trials public

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1 Contains clinical trial definition, grant, and posting
requirements. Section 2. Provides for the effective date.

 
JUSTIFICATION:

Obligating clinical trials to post information on their website is
necessary to best suit the medical needs of patients and increase trans-
parency. According to a study published by the National Library of Medi-
cine, only about 41 percent of clinical trials are posted on time, as
mandated by the Food and Drug Administration Amendments Act of 2007.
Section 801 of the act required "applicable clinical trial" (ACT) to
register their trials if they were initiated or ongoing after September
27th, 2007, were controlled clinical investigations (besides phase 1
investigations) of any Food and Drug-related drug or biological product.
The act also required certain FDA-regulated medical devices to register
their studies.

This delay in posting information regarding clinical trials hurts both
doctors and patients, as they are not informed of benefits, side
effects, target groups, and specific goals of the clinical trials.
Therefore, they cannot determine if a drug or treatment is a viable
option for them to use to deal with their illness. Clinical trials' lack
of representation and transparency leads to less than adequate medical
treatment. According to the Association of Clinical Research Profes-
sionals, minorities are vastly underrepresented in clinical trials.
African Americans make up only 5 percent of trial participants and
Hispanics make up less than 1 percent of trials participants. Race is
not the only factor showing a disparity between groups of people. The
ACRP also finds that patients with annual incomes of less than $50,000
are 27 percent less likely to participate in clinical trials because
they cannot find time due to their inability to get away from work, as
they need a constant source of income. Because minorities and those in
dire socioeconomic positions are not involved in clinical trials, there
is no concrete evidence that the tested treatment will help deal with
their medical issues.

The ACRP states how 5-Fluorouracil, a drug used for chemotherapy, can
cause hematologic toxicities like leukopenia and anemia. The drug caused
toxicities to occur more frequently in minority groups than Caucasian
people. The clinical trials for the drug were composed of mostly Cauca-
sian people, thus leading to inadequate results, as the effects the drug
would have on minority groups were never fully tested. The lack of
minority representation in clinical trials has shown that not involving
minority groups in studies can further harm the health of minority
groups.

By requiring conspicuous posts to be on clinical trials' websites, we
allow the public to inform themselves of the specifics of medical trials
so patients have the best and most clear treatments available.  Informa-
tion such as the stage and type of trial, active ingredients in drugs,
and statistics of trials are all clear information that will make clin-
ical trials more transparent and helpful.

This bill aims to increase the transparency between clinical trials and
the general public to have better treatment available for patients.

 
PRIOR LEGISLATIVE HISTORY:

New bill

 
FISCAL IMPLICATIONS:

None

 
EFFECTIVE DATE:
The act shall take effect immediately.

2021-S8190 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8190
 
                             I N  S E N A T E
 
                             February 1, 2022
                                ___________
 
 Introduced  by  Sen. PERSAUD -- 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 requiring clinical
   trials that apply for state grant funding to make certain  information
   about such clinical trials public
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Article 2 of the public health law is amended by  adding  a
 new title 8 to read as follows:
                                  TITLE 8
                              CLINICAL TRIALS
 SECTION 269.   DEFINITIONS.
         269-A. GRANT REQUIREMENTS.
         269-B. POSTING REQUIREMENTS.
   § 269. DEFINITIONS. FOR PURPOSES OF THIS TITLE:
   1. "CLINICAL TRIAL" SHALL HAVE THE SAME MEANING AS SET FORTH IN SUBDI-
 VISION TWO-B OF SECTION FORTY-NINE HUNDRED OF THIS CHAPTER.
   2.  "HEALTH  CARE PROVIDER" SHALL MEAN A PRACTITIONER IN AN INDIVIDUAL
 PRACTICE, GROUP PRACTICE, PARTNERSHIP, PROFESSIONAL CORPORATION OR OTHER
 AUTHORIZED FORM OF ASSOCIATION, A HOSPITAL OR OTHER HEALTH CARE INSTITU-
 TION ISSUED AN OPERATING CERTIFICATE PURSUANT TO  THIS  CHAPTER  OR  THE
 MENTAL  HYGIENE  LAW,  A CERTIFIED HOME HEALTH AGENCY OR A LICENSED HOME
 CARE SERVICES AGENCY, AND ANY OTHER PURVEYOR OF HEALTH OR HEALTH RELATED
 ITEMS OR SERVICES INCLUDING BUT NOT LIMITED TO A CLINICAL LABORATORY,  A
 PHYSIOLOGICAL  LABORATORY,  A  PHARMACY,  A PURVEYOR OF X-RAY OR IMAGING
 SERVICES, A PURVEYOR OF PHYSICAL THERAPY SERVICES, A PURVEYOR OF  HEALTH
 OR  HEALTH  RELATED  SUPPLIES,  APPLIANCES OR EQUIPMENT, OR AN AMBULANCE
 SERVICE.
   § 269-A. GRANT REQUIREMENTS. 1. FOLLOWING THE EFFECTIVE DATE  OF  THIS
 SECTION,  THE COMMISSIONER SHALL REQUIRE ANY SPONSOR OF A CLINICAL TRIAL
 IN THIS STATE, INCLUDING BUT  NOT  LIMITED  TO,  A  PHARMACEUTICAL  DRUG
 MANUFACTURER,  PHARMACEUTICAL  DRUG WHOLESALER, ACADEMIC MEDICAL CENTER,
 VOLUNTARY GROUP, FEDERAL AGENCY OR HEALTH CARE  PROVIDER,  THAT  APPLIES
 FOR  A STATE GRANT TO CONDUCT SUCH CLINICAL TRIAL, TO CONSPICUOUSLY POST
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD13525-02-2
 S. 8190                             2
 
 CERTAIN INFORMATION  ABOUT  SUCH  CLINICAL  TRIAL  ON  THE  DEPARTMENT'S
 WEBSITE.
   2. TO THE EXTENT DISCLOSURE IS PERMITTED UNDER FEDERAL LAW, THE INFOR-
 MATION  POSTED  IN ACCORDANCE WITH SUBDIVISION ONE OF THIS SECTION SHALL
 INCLUDE, BUT SHALL NOT BE LIMITED TO, THE FOLLOWING:
   (A) THE NAME OF ALL CLINICAL TRIAL SPONSORS, FUNDERS  AND  MANUFACTUR-
 ERS, INCLUDING THE NAME AND CONTACT INFORMATION, AS WELL AS THE INSTITU-
 TIONAL AFFILIATION, OF ALL SPONSORS, CO-SPONSORS AND ADMINISTRATORS;
   (B) A SUMMARY OF THE PURPOSE OF THE CLINICAL TRIAL, INCLUDING, BUT NOT
 LIMITED TO: (I) THE NAME OF THE PHARMACEUTICAL DRUG BEING TESTED AND ITS
 ACTIVE INGREDIENTS, IF APPLICABLE; (II) THE TYPE OF CLINICAL TRIAL TO BE
 CONDUCTED;  (III) THE OVERALL DESIGN OF THE STUDY, INCLUDING THE STATIS-
 TICAL METHOD TO BE EMPLOYED; (IV) THE STATUS OR PHASE TYPE OF THE TRIAL;
 (V) THE INCLUSION AND EXCLUSION CRITERIA;  (VI)  THE  TREATMENT  METHODS
 USED;  (VII)  ALL HYPOTHESES TESTED BY THE TRIAL; AND (VIII) THE MEDICAL
 CONDITION OR CONDITIONS BEING STUDIED;
   (C) THE START DATE AND END DATE OF THE CLINICAL TRIAL; AND
   (D) INFORMATION PERTAINING TO THE CLINICAL TRIAL, INCLUDING,  BUT  NOT
 LIMITED  TO  POTENTIAL  ADVERSE  EFFECTS  OF  THE PHARMACEUTICAL DRUG OR
 BIOLOGICAL PRODUCT ASSOCIATED WITH THE CLINICAL TRIAL.
   3. THE COMMISSIONER SHALL PROMULGATE RULES AND REGULATIONS  AS  DEEMED
 NECESSARY  TO  AID  IN  THE COLLECTION AND POSTING OF THE CLINICAL TRIAL
 INFORMATION REQUIRED PURSUANT TO THIS  SECTION  AND  SHALL  MONITOR  THE
 DEPARTMENT'S  WEBSITE  FOR  COMPLIANCE  WITH  THE  REQUIREMENTS  OF THIS
 SECTION.
   § 269-B. POSTING REQUIREMENTS. 1. FOLLOWING THE EFFECTIVE DATE OF THIS
 SECTION, THE COMMISSIONER SHALL REQUIRE ANY HEALTH CARE PROVIDER  OFFER-
 ING  A CLINICAL TRIAL IN THIS STATE TO CONSPICUOUSLY POST CERTAIN INFOR-
 MATION ABOUT SUCH CLINICAL TRIAL ON THEIR WEBSITE.
   2. TO THE EXTENT DISCLOSURE IS PERMITTED UNDER FEDERAL LAW, THE INFOR-
 MATION POSTED IN ACCORDANCE WITH SUBDIVISION ONE OF THIS  SECTION  SHALL
 INCLUDE, BUT SHALL NOT BE LIMITED TO, THE FOLLOWING:
   (A) THE THERAPEUTIC INTENT OF THE CLINICAL TRIAL;
   (B)  THE  NAME OF ALL CLINICAL TRIAL SPONSORS, FUNDERS AND MANUFACTUR-
 ERS, INCLUDING THE NAME AND CONTACT INFORMATION, AS WELL AS THE INSTITU-
 TIONAL AFFILIATION, OF ALL SPONSORS, CO-SPONSORS AND ADMINISTRATORS;
   (C) A SUMMARY OF THE PURPOSE OF THE CLINICAL TRIAL, INCLUDING, BUT NOT
 LIMITED TO: (I) THE NAME OF THE PHARMACEUTICAL DRUG BEING TESTED AND ITS
 ACTIVE INGREDIENTS, IF APPLICABLE; (II) THE TYPE OF CLINICAL TRIAL TO BE
 CONDUCTED; (III) THE OVERALL DESIGN OF THE STUDY, INCLUDING THE  STATIS-
 TICAL METHOD TO BE EMPLOYED; (IV) THE STATUS OR PHASE TYPE OF THE TRIAL;
 (V)  THE  INCLUSION  AND  EXCLUSION CRITERIA; (VI) THE TREATMENT METHODS
 USED; (VII) ALL HYPOTHESES TESTED BY THE TRIAL; AND (VIII)  THE  MEDICAL
 CONDITION OR CONDITIONS BEING STUDIED;
   (D) THE START DATE AND END DATE OF THE CLINICAL TRIAL; AND
   (E)  INFORMATION  PERTAINING TO THE CLINICAL TRIAL, INCLUDING, BUT NOT
 LIMITED TO POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE CLINICAL TRIAL.
   § 2. This act shall take effect immediately.

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Senate Bill S8190

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Sponsored By

Roxanne J. Persaud