New FDA Policy Seeks to Make Adverse-Event Reporting During Clinical Trials More Meaningful


The effort seeks to cut down on “reporting-data noise that may mask true signals of significant adverse events.”

New FDA policy effective this March more clearly specifies how and when adverse events during clinical trials should be reported, according to an article published June 8 in Health Policy and Reform.

The effort seeks to cut down on “reporting-data noise that may mask true signals of significant adverse events.” The authors state that because FDA had until now not established a threshold of when adverse events should be reported, sponsors of clinical trials being conducted under investigational new drug (IND) applications were reporting an excess number of serious adverse events-often without clearly establishing whether or not those events were definitively related to the drug.

Additionally, the article authors point out, the adverse events reported were often already common in the study population or in the disease under investigation, regardless of drug therapy. “Under these circumstances, it is impossible to determine whether drug exposure is causally related to the event,” the article authors state.

With the new policy in place, the hope is that adverse reporting will become “more meaningful and relevant to patients’ safety,” the article authors state.

According to the authors, under the new rule’s guidelines, clinical investigators should:

  • Report a serious, unexpected adverse reaction to FDA if it is an event not previously observed with the drug and is likely to have been caused by the drug.

  • Report an adverse event to FDA only if it is observed in the drug group but not in the control group and is thus likely caused by the drug.

  • Clinical investigators must now report all serious adverse events to the trial’s sponsor, whether or not the event may be related to the drug. The authors point out that previously, events only needed to be reported to the sponsor if they were suspected as being caused by the drug. However, the new regulation takes into account that trial sponsors should be aware of the complete history of adverse events related to the drug and thus can better make the judgment call of whether a newly reported event is significant.

  • Per previous FDA rules, adverse events must still be reported in a timely manner (usually within 15 days and within 7 days if the event was fatal).

The authors conclude by stating, “We believe that the new regulation will improve the quality of safety reporting and strengthen the FDA’s ability to monitor the safety of drug and biologic products. It will minimize reports that do not contribute to the understanding of a drug’s developing safety profile and decrease the number of uninterpretable reports.”

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