State law on Clinical Research trials
1997: Congress Passes Law (FDAMA) Requiring Trial Registration
The first U.S. Federal law to require trial registration was the (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.
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.
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In 2000, FDA issued a draft Guidance for Industry document, which provided recommendations for researchers submitting information to ClinicalTrials.gov.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In January 2004, FDA proposed a revised draft Guidance for Industry document that included guidance for researchers submitting information required by the Best Pharmaceuticals for Children Act of 2002.
2004: ClinicalTrials.gov Wins the Innovations in American Government Award
In 2004, 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. The 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.