A recent article published by the New England Journal of Medicine describes a recent rule enacted by the Food and Drug Administration that aims to improve regulatory practices in safety reporting for clinical trials. This rule was published in September 2010, and came into effect on March 28, 2011. Specifically, the rule addresses the issue of adverse reporting during the clinical phase by describing the types of events that should be reported and by appealing to those responsible for reporting these events.
Under this new rule, the FDA emphasizes the importance of patient safety during the critical clinical trial phase that is a precursor to a drug or biological product being placed on the market. In the past, drug developers and sponsors were able to choose whether or not to report an “adverse event” during a clinical trial, and often did so in an expedited manner. Indeed, the authors explain that “the FDA’s previous safety-reporting requirements were not specific regarding the threshold for deeming an adverse event reportable…”
However, under the new reporting guidelines set forth by the FDA, clinical investigators must now report all serious adverse events to those sponsoring the clinical trial, regardless as to whether the event is considered related to the drug or product being studied. By enacting this rule, the FDA seeks to improve safety reporting while strengthening the agency’s commitment to monitoring the passage of drugs and biologic products into the market.
See the full article at
Article from New England Journal of Medicine: “New FDA Regulation to Improve Safety Reporting in Clinical Trials”
FDA rule regarding biological products
FDA rule regarding industry guidelines for saftey reporting
FDA guidance for industry and investigators regarding safety reporting