The volumes and volumes of data on safety and efficacy that reside in drug applications at the FDA might well hold answers the agency seeks when it requires drug developers to expand trials or run additional ones. Most of those data, however, rest in unsearchable paper submissions or cumbersome electronic files that thwart attempts at analysis.
The 70 percent of drug applications submitted in electronic format last year represents great automation progress since 2007, when the figure was just 37 percent. But, says the Boston Globe, many of those submissions--comprising "millions of data points from a multitude of clinical studies--are virtually impossible to use."
An FDA intent on improving drug safety while also advancing regulatory science to help rein in development costs needs to do more than raise the data bar on drug sponsors. It must raise the agency IT bar to allow mining of its own data stores in support of drug approvals.
- see the editorial