FDA beefs up safety reporting during CTs

Clinical trials now will have to report a number of safety incidents that previously were not reported, according to a final rule issued by the U.S. Food and Drug Administration (FDA). The regulation deals with reporting safety information during clinical trials of investigational drugs and biologics.

The rule is intended to expedite the FDA's review of critical safety information and provide better protection for clinical trial participants, the FDA said in a statement issued Sept. 28, 2010.

Research sites will have 15 days from being made aware of an occurrence to report the following types of events:

  • Findings from clinical or epidemiological studies that suggest a significant risk to study participants;
  • Serious suspected adverse reactions that occur at a rate higher than expected;
  • Serious adverse events from bioavailability and bioequivalence studies, which are conducted for generic drugs.

These bioavailability and bioequivalence studies are used to determine what percentage of drug is absorbed in the bloodstream and whether the drug has the same strength and effects people the same way as the brand name drug.

The final rule provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under current regulations, drug sponsors often report all serious adverse events, including those that likely were not caused by the product being studied. The FDA seeks to eliminate the "noise" or unnecessary data from its database to simplify the task of detecting safety signals.

Now clinical trial sites have some concrete examples addressing when a single event should be reported or when there is a need to wait for more than one occurrence.

Also, the final rule revises definitions and reporting standards to make these more consistent with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization's Council for International Organizations of Medical Sciences. The FDA's changes are designed to ensure harmonized reporting of global clinical trials.

Researchers and others in the industry could find more information and advice about the new requirements through the FDA's draft guidance and by visiting the website: www.fda.gov/ssLINK/ucm226358.htm.