CLINICALTRIALS.GOV is a registry of clinical trials . It is run by
* 1 History * 2 Trial record life-cycle * 3 Later developments * 4 Relationship to PubMed * 5 See also * 6 References * 7 External links
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 (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 (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.
National Library of Medicine in the National Institutes of Health
As the result of toxicity tracking concerns raised following
retraction of several drugs from the prescription market,
* Data elements that facilitate disclosure, as required by the FDAAA, as well as operations of ClinicalTrials.gov; and * "Basic results" reporting.
TRIAL RECORD LIFE-CYCLE
The trial typically goes through stages of: initial registration, ongoing record updates, and basic summary result submission. Each trial record is administered by trial record manager. A trial record manager typically provides initial trial registration prior the study enrolls the first participant. This also facilitates informing potential participants that the trial is no longer recruiting participants. Once all participants were recruited, the trial record may be updated to indicate that is closed to recruitment. Once all measurements are collected (the trial formally completes), the trial status is updated to 'complete'. If the trial terminates for some reason (e.g., lack of enrollment, evidence of initial adverse outcomes), the status may be updated to 'terminated'. Once final trial results are known or legal deadlines are met, the trial record manager may upload basic summary results to the registry either by filling a complex web-based form or submitting a compliant XML file.
In a 2009 meeting of the National Institutes of Health speakers said that one of the goals was to have more clearly defined and consistent standards for reporting. As of March 2015, the NIH was still considering the details of this rule change.
A study of trials conducted between 2008 and 2012 found that about half of those required to be reported had not been. A 2014 study of pre-2009 trials found that many had serious discrepancies between what was reported on clinicaltrials.gov versus the peer-reviewed journal articles reporting the same studies.
RELATIONSHIP TO PUBMED
PubMed is another resource managed by the National Library of
Medicine . A trial with an NCT identification number that is
Clinical trials registry
Academic clinical trials
Clinical data acquisition
Clinical Data Interchange Standards Consortium
Community-based clinical trial
Contract Research Organization
Data Monitoring Committees
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