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