FDA Increases Public's Exposure to Clinical Trials
The FDA is increasing its public reporting process of information about clinical trials and their results, as mandated under the Food and Drug Amendments Act of 2007.
The act expands the scope of clinical trials that must submit data to the U.S. National Institute of Health's www.clinicaltrials.gov website. Registration information on a trial must be posted within 21 days of enrolling the first subject, and changes within a trial must be posted within 30 days. Results of a trial must be posted within 12 months of completion in most cases. The FDA says that registration information will be required for 3,000 trials of drugs and biologics, and 445 trials of medical devices annually. The agency also estimated that nearly 12,000 other voluntary data submissions will be collected.
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