FDA Readies More Trial Reporting

October 8, 2008

The Food and Drug Administration is taking steps to increase public reporting of information about clinical trials and their results as mandated under the Food and Drug Amendments Act of 2007.

The act, among other provisions, expands the scope of clinical trials that must submit information to the ClinicalTrials.gov Web site. Registration information on a trial must be posted within 21 days of enrolling the first subject. Changes within a trial must be posted within 30 days. Results of a trial must be posted within 12 months of completion, with waivers in certain circumstances.

The FDA estimates that registration information will be required for 3,000 trials of drugs and biologics and 445 trials of medical devices each year. The agency also estimates nearly 12,000 other voluntary submissions of information from a variety of trials. As of late December 2007, the ClinicalTrials.gov Web site had information on 7,000 trials on drugs and biologics and 650 on medical devices.

More information on new reporting requirements and FDA's estimated burden for meeting the requirements is available in a notice published Oct. 8 in the Federal Register, available here.

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