S T A T E O F N E W Y O R K
________________________________________________________________________
1755
2025-2026 Regular Sessions
I N S E N A T E
January 13, 2025
___________
Introduced by Sens. PERSAUD, HOYLMAN-SIGAL -- 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 9 to read as follows:
TITLE 9
CLINICAL TRIALS
SECTION 269-B. DEFINITIONS.
269-C. GRANT REQUIREMENTS.
269-D. POSTING REQUIREMENTS.
§ 269-B. 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-C. 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
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD05050-01-5
S. 1755 2
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.
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-D. 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.