As a result of pressure from HIV-infected men in the gay community, who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (HOPE or Public Law 100-607) which mandated the development of a database of AIDS Clinical Trials Information System (ACTIS). 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.
The Food and Drug Administration Modernization Act of 1997 (FDAMA or Public Act 105-115) amended the Food, Drug and Cosmetic Act and the Public Health Service Act to require that the NIH create and operate a public information resource, which came to be called ClinicalTrials.gov, tracking drug efficacy studies resulting from approved Investigational New Drug (IND) applications (FDA Regulations 21 CFR Parts 312 and 812). With the primary purpose of improving access of the public to clinical trials where individuals with serious diseases and conditions might find experimental treatments, this law required information about:
- Federally and privately funded clinical trials;
- The purpose of each experimental drug;
- Subject eligibility criteria to participate in the clinical trial;
- The location of clinical trial sites being used for a study; and
- A point of contact for patients interested in enrolling in the trial.
The National Library of Medicine in the National Institutes of Health made ClinicalTrials.gov available to the public via the Internet on February 29, 2000. In this initial release, ClinicalTrials.gov primarily included information about NIH-sponsored trials, omitting the majority of clinical trials being performed by private industry. On March 29, 2000 the FDA issued a Draft Guidance called Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank and put into In) with the hope that this would increase use by industry. After a second draft guidance was released in June 2001, a final guidance was issued on March 18, 2002 titled Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. The Best Pharmaceuticals for Children Act of 2004 (BPCA or Public Law 107-109 amended the Public Health Service Act to require that additional information be included in ClinicalTrials.gov.
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 (FDAAA or U.S. Public Law 110-85) which mandated the expansion of ClinicalTrials.gov for better tracking of the basic results of clinical trials, requiring:
- Data elements that facilitate disclosure, as required by the FDAAA, as well as operations of ClinicalTrials.gov; and
- "Basic results" reporting.
Read more about this topic: Clinical Trials.gov
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