Food and Drug Administration Modernization Act (FDAMA) Section 113 and ClinicalTrials.gov

Background

Food and Drug Modernization Act (FDAMA)
In November 1997, Congress included a provision in the Food and Drug Modernization Act to mandate that the National Institutes of Health (NIH) establish, maintain, and operate a public resource for information on efficacy studies of drugs, including biological drug products, to treat serious or life-threatening diseases and conditions conducted under the FDA's investigational new drug (IND) regulations (21 CFR parts 312 and 812).

ClinicalTrials.gov

The NIH, through its National Library of Medicine (NLM), with input from the FDA and others, developed the Clinical Trials Data Bank, a central resource, providing current information on clinical trials to individuals with serious or life-threatening diseases or conditions, to other members of the public, and to health care providers and researchers. The first version of the Clinical Trials Data Bank was made available to the public via the Internet on February 29, 2000. At that time, the data bank, known as ClinicalTrials.gov included primarily NIH-sponsored trials.

Section 113 of the Modernization Act required that the Clinical Trials Data Bank contain the following information: (1) Information about Federally and privately funded clinical trials for experimental treatments (drug and biological products) for patients with serious or life-threatening diseases or conditions, (2) a description of the purpose of each experimental drug, (3) patient eligibility criteria, (4) a description of the location of clinical trial sites, and (5) a point of contact for patients wanting to enroll in the trial, all in a form that could be readily understood by the public.

FDAMA Section 113: Status Report on Implementation (August 2005)
FDA's Office of Special Health Issues undertook a multifaceted project to educate sponsors of investigational new drug applications about FDAMA Section 113 and to assess sponsor compliance with the law. The report describes methods used during various components of the project, presents findings, and discusses recommendations for helping to increase participation in ClinicalTrials.gov.

FDAMA Section 113: Analysis of Cancer Trials Submitted May - July, 2005 (June 2006)
A report of cancer clinical trial protocol submissions to FDA over a three month period (May 1, 2005 through July 31, 2005) to determine whether clinical trials were listed in the ClinicalTrials.gov database, and assess why trials may not have been listed.

FDA Guidance for Industry

On March 29, 2000, FDA issued in the Federal Register (65 FR Number 61 16620) a Notice of Availability of Draft Guidance entitled Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank. (PDF 129KB). The draft "Guidance for Industry" (PDF 656 KB) provided recommendations for industry on submitting protocol information to the Clinical Trials Data Bank. It included information about the types of clinical trials for which submissions are required under section 113 of FDAMA as well as the content and format requirements of those submissions and provided recommendations for industry on the submission of protocol information to the Clinical Trials Data Bank.

On July 9, 2001, FDA announced in the Federal Register (66 FR 35798) the availability of a second draft guidance entitled Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan. This second draft guidance (PDF 968 KB) addressed procedural issues, including how to submit required and voluntary protocol information to the Clinical Trials Data Bank, as well as issues related to submitting certification to the Secretary that disclosure of information for a particular protocol would substantially interfere with the timely enrollment of subjects in the clinical investigation. The second draft guidance also proposed a time frame for submitting the information.

On March 18, 2002, FDA issued a Federal Register Notice (67 FR 12022) (PDF 41 KB) announcing the availability of final Guidance for Industry entitled Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. The final Guidance combines the two draft guidance documents into a single document and incorporates public comments received on the draft guidances.

Best Pharmaceuticals for Children Act

On January 27, 2004, FDA issued a Federal Register Notice (Volume 69, Number 17) revising the March 2002 guidance for industry to include guidance for sponsors who would be submitting information required by the Best Pharmaceuticals for Children Act (BPCA) (PDF version 76KB) (Public Law 107-109). The BPCA amended the Public Health Service Act (PHS Act) to require that additional information be included in the Clinical Trials Data Bank established under FDAMA.

The January 2004 draft guidance for industry, is designed to augment information available in the Clinical Trials Data Bank with a description of whether, and through what procedure, the sponsor of the research will respond to requests for access to the therapy outside of the clinical trial setting. The draft guidance explains how to provide that information in a straightforward and efficient way.

Other Information

A National Resource for Information on Clinical Trials, McCray AT (Summer 1999)
A narrative overview of ClinicalTrials.gov

A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry: A Report to Congress by the Secretary of Health and Human Services (November 1999)
The Department of Health and Human Services (DHHS) report generated in response to the requirement under Section 113 (b) of the Food and Drug Administration Modernization Act of 1997 (FDAMA) to determine the feasibility of including device clinical trials within the scope of the PHS data bank established by §113 (a) of FDAMA.

Design and Implementation of a National Clinical Trials Registry McCray AT and Ide NC (May, 2000)
Describes the Web-based system that provides summary information about clinical trials being conducted throughout the United States, based on requirements of the Food and Drug Administration (FDA) Modernization Act of 1997, which mandated a registry of both federally and privately funded clinical trials "of experimental treatments for serious or life-threatening diseases or conditions."

Better Access to Information about Clinical Trials, McCray AT (October, 2000)
Reviews existing clinical trials registries, discusses the challenges in building registries, and reviews some of their benefits.

In January 2002, the FDA Office of Special Health Issues (OSHI) initiated a project to educate private sector sponsors about their statutory reporting requirements under FDAMA Section 113, and evaluate the number of protocols submitted to the Clinical Trials Data Bank to measure fulfillment of those responsibilities. Preliminary results from this project were discussed at the 2003 FDA Science Forum and various other public presentations (Derbis, J. Toigo, T. Woods, J. Evelyn,B. Banks, D FDAMA Section 113: Information Program on Clinical Trials for Serious or Life Threatening Diseases: Update on Implementation)

FDAMA Section 113: 2005 Status Report on Implementation

ClinicalTrials.gov Milestone: October 2003, FDA acknowledged the listing of the 1000th industry-sponsored trial in ClinicalTrials.gov (U.S. Food and Drug Administration. A Milestone for ClinicalTrials.gov Web Site

Food and Drug Modernization Act (FDAMA) Section 113: Status Report on Implementation, Theresa Toigo.
Reprinted with permission. J. BIOLAW & BUS., Vol. 7, No. 2, 2004

Design, Implementation and Management of a Web-based Data Entry System for ClinicalTrials.gov,
Gillen JE, Tse T, Ide NC, McCray AT (2004)
Describing the development and deployment of a web-based authoring capability, the first implementation of which is used for data entry and management in support of the ClinicalTrials.gov web site.

January 2004 Guidance for Industry - Information Program on Clinical Trials for Serious or
Life-Threatening Diseases and Conditions, Draft Guidance. (PDF, 39.94 KB) This draft updates the Final Guidance to include the Best Pharmaceuticals for Children Act (BPCA) requirement that additional information be included in the Clinical Trials Data Bank, including a description of whether, and through what procedure, the manufacturer or sponsor of an investigation of a new drug will respond to requests for a protocol exception, with appropriate safeguards, for single-patient and expanded access use of the investigational drug, particularly in children.

Promoting ClinicalTrials.gov and Clinical Trials Education

Promoting ClinicalTrials.gov -- FDA and National Library of Medicine (NLM) took to the airwaves to promote ClinicalTrials.gov, including an interview with then FDA Commissioner, Mark McClellan.

Public Service Print Announcement produced as part of an FDA partnership to encourage clinical trial education. (Low resolution PDF, 72KB) | (High resolution PDF, 12MB, for print purposes)

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