FDA unveils new trial data rules
pharmafile | October 1, 2010 | News story | Research and Development | FDA, clinical trials, pharmacovigilance
The FDA has clarified its rules on what safety information must be reported during clinical trials of investigational drugs and biologics.
A new rule from the US regulator outline a range of trial data that has to be reported within 15 days in an effort to shore up the industry’s pharmacovigilance practices.
Rachel Behrman, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research, said: “This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics.
“These changes will better protect people who are enrolled in clinical trials,” she added.
Under current regulations, drug sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event.
But such inclusive reporting can complicate and delay the FDA’s ability to detect a ‘safety signal’ and the agency has outlined a range of examples of when a single event should be reported, including:
• 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 studies which determine what percentage and at what rate drug is absorbed by the bloodstream, and
• Bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug
The rule also includes examples of evidence that would suggest that an investigational product may be the cause of a safety problem.
In addition, the rule revises definitions and reporting standards so that they are more consistent with two international organisations, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the WHO’s Council for International Organisations of Medical Sciences.
The FDA said that the “changes are designed to help ensure harmonised reporting of globally conducted clinical trials”.
Ben Adams
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