[1] As a result of pressure from HIV-infected men in the gay community,[citation needed] who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607)[2] which mandated the development of a database of AIDS Clinical Trials Information Services (ACTIS).

[3] This effort served as an example of what might be done to improve public access to clinical trials, and motivated other disease-related interest groups to push for something similar for all diseases.

On March 29, 2000 the FDA issued a Draft Guidance called Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank[7] and put into In) with the hope that this would increase use by industry.

As the result of toxicity tracking concerns raised following retraction of several drugs from the prescription market, ClinicalTrials.gov was further reinforced by the Food and Drug Administration Amendments Act of 2007 (U.S. Public Law 110-85)[12] which mandated the expansion of ClinicalTrials.gov for better tracking of the basic results of clinical trials, requiring:[13] In a 2009 meeting of the National Institutes of Health[15] speakers said that one of the goals was to have more clearly defined and consistent standards for reporting.

The trial typically goes through stages of: initial registration, ongoing record updates, and basic summary result submission.

If the trial terminates for some reason (e.g., lack of enrollment, evidence of initial adverse outcomes), the status may be updated to 'terminated'.