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History, Policies, and Laws

This page provides information on selected events, policies and laws related to the development and expansion of ClinicalTrials.gov. It is not intended to be comprehensive.

Contents

1997: Congress Passes Law (FDAMA) Requiring Trial Registration

The first U.S. Federal law to require trial registration was the Food and Drug Administration Modernization Act of 1997 (FDAMA) (PDF).

Section 113 of FDAMA required that the National Institutes of Health (NIH) create a public information resource on certain clinical trials regulated by the Food and Drug Administration (FDA). Specifically, FDAMA 113 required that the registry include information about federally or privately funded clinical trials conducted under investigational new drug applications (INDs) to test the effectiveness of experimental drugs for patients with serious or life-threatening diseases or conditions.

The information in the registry was intended for a wide audience, including individuals with serious or life-threatening diseases or conditions, members of the public, health care providers, and researchers.

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2000: NIH Releases ClinicalTrials.gov Web Site

With input from FDA and others, the NIH National Library of Medicine (NLM) developed ClinicalTrials.gov. The first version of ClinicalTrials.gov was made available to the public on February 29, 2000. At the time, ClinicalTrials.gov primarily included NIH-funded studies.

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2000–2004: FDA Issues Guidance for Industry Documents

In 2000 FDA issued a draft Guidance for Industry document, which provided recommendations for researchers submitting information to ClinicalTrials.gov. A final guidance document that incorporated comments from the public was issued in 2002.

In January 2004 FDA proposed a revised draft Guidance for Industry document that included guidance for researchers submitting information required by the Best Pharmaceuticals for Children Act of 2002 (BPCA).

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2004: ClinicalTrials.gov Wins the Innovations in American Government Award

ClinicalTrials.gov was cited by the Ash Center for Democratic Governance and Innovation at the Harvard Kennedy School as "a successful model for the creation and maintenance of a system that processes and presents large amounts of specialized information to a wide range of users" and was selected as one of five award winners in 2004. The Innovations in American Government Awards is the nation's preeminent program devoted to recognizing and promoting excellence and creativity in the public sector. The program highlights exemplary models of government innovation and advances efforts to address the nation's most pressing public concerns.

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2005: International Committee of Medical Journal Editors Requires Trial Registration

In 2005 the International Committee of Medical Journal Editors (ICMJE) began to require trial registration as a condition of publication.

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2005: State of Maine Passes Clinical Studies Registration Law (Repealed in 2011)

In 2005 the State of Maine passed a law requiring prescription drug manufacturers or labelers to submit clinical study registration and results information to ClinicalTrials.gov. The law applied to FDA-approved prescription drugs that are dispensed, administered, delivered, or promoted in Maine.

In 2011 the law was repealed; it is no longer in effect.

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2006: World Health Organization Establishes Trial Registration Policy

In 2006 the World Health Organization (WHO) stated that all clinical trials should be registered, and it identified a minimum trial registration dataset of 20 items. In 2007 WHO launched the International Clinical Trials Registry Platform (ICTRP), which includes a search portal providing a single point of access to studies registered in various international registries. The ICTRP Search Portal includes data available on ClinicalTrials.gov.

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2007: Congress Passes Law (FDAAA) Expanding ClinicalTrials.gov Submission Requirements

In 2007 the requirements for submission to ClinicalTrials.gov were expanded after Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PDF) Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered; additional trial registration information; and the submission of summary results, including adverse events, for certain trials. The law also included penalties for noncompliance, such as the withholding of NIH grant funding and civil monetary penalties of up to $10,000 a day.

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2008: ClinicalTrials.gov Releases Results Database

In September 2008, as required by FDAAA 801, ClinicalTrials.gov began allowing sponsors and principal investigators to submit the results of clinical studies. Submission of adverse event information was optional when the results database was released and became required in September 2009.

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2008: Declaration of Helsinki Revision Promotes Trial Registration and Results Dissemination

In October 2008, the 59th World Medical Association (WMA) General Assembly amended the Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. In particular, paragraph 19 requires prospective trial registration, as follows: "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject."

Paragraph 30 promotes the public disclosure of study results as an ethical obligation and states, in part, "Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available."

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2009: Public Meeting Held at the National Institutes of Health

In accordance with FDAAA 801, NIH held a public meeting in April 2009 to solicit input from interested individuals about future regulations that will expand the information contained in ClinicalTrials.gov.

NIH gathered input on a range of issues, including the submission of adverse events information and the addition of narrative summaries to results submission. Comments on these issues will be used in the development of draft regulations.

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Present: Development of Notice of Proposed Rulemaking

In the future, NIH will issue regulations on procedures for registering and submitting the results, including adverse events, of clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. A notice of proposed rulemaking (NPRM) and request for comments from the public on the development of the final rule (regulations) will be issued before the final regulations are written. The rulemaking process will also consider regulations intended to provide more complete results information and enhance patient access to and understanding of the results of clinical trials, including:

  • Whether results information should be required to be submitted for applicable clinical trials of drugs, biological products, or devices that have not been approved, licensed, or cleared by FDA
  • Whether narrative summaries of clinical trials and their results can be included in the data bank without being misleading or promotional
  • Whether the full protocol should be submitted to help evaluate the results of the trial

Regulatory information: See the U.S. Department of Health and Human Services Fall 2012 Unified Agenda.

This page last reviewed in August 2012