The FDA may accept safety analyses drawn and projected out from pooled clinical trial data as long as sponsors have carefully planned their evaluations and are willing to show their work, the agency said in new draft guidance.
Randomized clinical trials sometimes have trouble creating big enough sample sizes to detect adverse events and to determine whether the adversity is tied to a drug or device. In those cases, drawing inferences from pooled data — or a meta-analysis — can be an effective way to analyze a treatment’s safety.
“Our goal is to encourage more pooled studies to evaluate important safety events,” FDA Commissioner Scott Gottlieb said in announcing the draft guidance. Because meta analyses can influence regulatory decisions, “rigorous principles should be applied to these studies,” he said.