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 its website, www.clinicaltrials.gov. 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, with certain exceptions.
The FDA said 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.
As of December 2007, the FDA’s clinical trials site had information on 7,000 trials on drugs and biologics and 650 on medical devices.