FDA Rules on Clinical Trials Safety Information

Abstract

The US Food and Drug Administration (FDA) on September 28, 2010, issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. This final rule is expected to improve the quality of safety reports submitted to the FDA, thereby enhancing the safety of patients in clinical trials. According to the agency, the rule “lays out clear, internationally harmonized definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing reporting of meaningful, interpretable information. “This final rule will expedite FDA's review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” said Rachel Behrman, MD, associate director for medical policy in the FDA's Center for Drug Evaluation and Research. “These changes will better protect people who are enrolled in clinical trials.” The new rule requires that certain safety information that previously had not been required to be reported to FDA be reported within 15 days of becoming aware of an occurrence. These reports include findings from clinical or epidemiologic studies that suggest a significant risk to study participants; serious suspected adverse reactions that occur at a rate higher than expected; and serious adverse events from bioavailability and bioequivalence studies, which are typically conducted for generic drugs to determine what percentage of drug is absorbed by the bloodstream and whether the drug has the same strength and effects people the same way as the brand name drug. The rule also 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, even if there is little reason to believe the product caused the event. Such reporting complicates and delays the FDA's ability to detect a safety signal. The examples address when a single event should be reported or when there is need to wait for >1one occurrence. In addition, the rule revises definitions and reporting standards so that they are more consistent with 2 international organizations, 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 changes are designed to help ensure harmonized reporting of globally conducted clinical trials. Along with this final rule, the FDA also issued a draft guidance for industry and investigators that provides information and advice about the new requirements and other information. For more information, see: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm226358.htm.