Meta-Analysis and Medical Technology Safety
In addition to the US Food and Drug Administration’s (FDA) regulatory role to approve or disapprove new medical technologies, its role as a Public Health Agency also requires prevention of safety problems. Because evidence for approval of new medical technology is often based on the results of small controlled clinical trials, the patient population and the provider population in the real world can differ dramatically from the trial populations; adverse events are particularly difficult to measure. We review approaches to making inference on the basis of observational data, focusing on the role of meta-analysis of studies of rare events. Two examples illustrate approaches: assessing (1) cardiovascular safety of rosiglitazone in diabetic patients and (2) safety of drug-eluting compared to bare metal coronary stents in a large cohort of adults undergoing angioplasty.