ASSEMBLY, No. 3684

 

STATE OF NEW JERSEY

 

211th LEGISLATURE

 

INTRODUCED JANUARY 11, 2005

 

 

Sponsored by:

Assemblyman ANTHONY CHIAPPONE

District 31 (Hudson)

Assemblyman JOHN F. MCKEON

District 27 (Essex)

Assemblyman JEFF VAN DREW

District 1 (Cape May, Atlantic and Cumberland)

 

Co-Sponsored by:

Assemblymen Diegnan, Wolfe and Assemblywoman Voss

 

 

 

 

SYNOPSIS

    Creates New Jersey Clinical Trials Registry in DHSS.

 

CURRENT VERSION OF TEXT

    As introduced.

 

(Sponsorship Updated As Of: 5/6/2005)


An Act concerning clinical trials and supplementing Title 26 of the Revised Statutes.

 

    Be It Enacted by the Senate and General Assembly of the State of New Jersey:

 

    1. This act shall be known and may be cited as the "Statewide Clinical Trials Registry Act."

 

    2. The Legislature finds and declares that the establishment of a comprehensive Statewide registry of clinical trials that requires disclosure of trial results, regardless of outcome, will serve public health purposes by enabling researchers, health care providers, patients and the general public to accurately assess information concerning the safety of drugs and biological products tested in this State.

 

    3. As used in this act:

    "Clinical trial" means a clinical investigation as defined by the federal Food and Drug Administration that involves any experiment to test the safety or efficacy of a drug or biological product with one or more human subjects and is intended to be submitted to, or held for inspection by, the federal Food and Drug Administration as part of an application for a research or marketing permit.

    "Commissioner" means the Commissioner of Health and Senior Services.

    "Department" means the Department of Health and Senior Services.

    "Registry" means the New Jersey Clinical Trials Registry established pursuant to this act.

 

    4. a. There is created in the Department of Health and Senior Services the New Jersey Clinical Trials Registry. The purpose of the registry shall be to serve as a comprehensive repository of information regarding all clinical trials conducted in this State, including information about the results of such trials, regardless of outcome.

    b. The commissioner shall establish and maintain a data bank of information on clinical trials conducted in this State, which data bank shall be the basis for information provided in the registry. The registry shall be made publicly available on the Internet and shall be in a form that can be readily understood by members of the public. To the extent that disclosure is permitted under federal law, the registry shall include, but not be limited to, the following information:

    (1) name of manufacturer or clinical trial sponsor;

    (2) summary of the purpose of the clinical trial; 

    (3) date when trial is to begin;

    (4) information pertaining to the results of the clinical trial, including potential or actual adverse effects of the drug or biological product associated with the clinical trial; and

    (5) any other information determined by the commissioner to be relevant.

 

    5. Prior to the commencement of a clinical trial that is conducted entirely in this State or as part of a multi-site investigation with at least one location in this State, the manufacturer or sponsor of a clinical trial shall register with:

    a. the department and provide information required pursuant to subsection b. of section 4 of this act; and

    b. ClinicalTrials.gov, the Internet site developed by the National Institutes of Health.

 

    6. Notwithstanding any other provision of the law to the contrary, a person or entity who is required to or authorized by the commissioner to report, receive or disclose information relating to the registry pursuant to this act shall be immune from liability for reporting, receiving or disclosing such information in accordance with the provisions of this act or with any regulation adopted pursuant thereto.

 

    7. The commissioner shall adopt rules and regulations, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), to effectuate the purposes of this act.

 

    8. This act shall take effect on the 90th day after enactment and shall apply to clinical trials commenced after the effective date of this act. The commissioner may take such anticipatory administrative action in advance as shall be necessary for the implementation of the act.

 

STATEMENT

 

    This bill would establish the "New Jersey Clinical Trials Registry" in the Department of Health and Senior Services (DHSS) to provide a comprehensive repository of information concerning clinical trials conducted in this State, including information about results of clinical trials.

    It has recently come to light that some pharmaceutical drug manufacturers may not have disclosed unfavorable clinical trial results concerning some of their drugs, thereby placing consumers at risk. The purpose of this bill is to address clinical trial disclosure practices involving research undertaken in this State by establishing a State registry and requiring disclosure of clinical trial results.

    The Commissioner of DHSS would establish and maintain a data bank of information on clinical trials conducted in this State, and the information would be the basis for the registry. The registry would be made publicly available on the Internet and shall be in a form that can be readily understood by members of the public. To the extent permitted under federal law, the registry shall include, but not be limited to, the following information:

    - name of manufacturer or clinical trial sponsor;

    - summary of the purpose of the clinical trial; 

    - date when trial is to begin;

    - information pertaining to the results of the clinical trial, including potential or actual adverse effects of the drug or biological product associated with the clinical trial; and

    - any other information determined by the commissioner to be relevant.

    A manufacturer or sponsor of a clinical trial conducted entirely in this State or as part of a multi-site investigation in which at least one location is in this State would be required to register with DHSS, as well as with ClinicalTrials.gov, the Internet site developed by the National Institutes of Health.

    The bill would take effect on the 90th day following enactment, and would apply to clinical trials commenced after the effective date.