FDA Mini-Sentinel project exceeds its goals, but future is uncertain

Effort to use health records to detect 'safety signals' will connect to other national programs: here comes IMEDS

In mid-January, the Mini-Sentinel project, an offshoot of a broader Sentinel Initiative within FDA, held what could be its last meeting; it was set up with a now-expiring five-year plan, and there has been no announced effort to keep it going. Janet Woodcock, one of the spearheads of the effort within FDA, said in a keynote address that the Sentinel Initiative itself has been cobbled together from funding from various FDA units, and the ability to do that going forward will depend on the overall FDA budget for the coming year.

Mini-Sentinel was intended to put into practice, quickly and effectively, several of the basic principles behind the Sentinel Initiative: that data in today’s healthcare environment, increasingly based on digitized records, could be used to catch subtle but important safety signals about drug use (Sentinel itself came out of the controversy over the Vioxx debacle of a decade ago); and that the science and methodology of pharmacovigilance could be advanced and broadened. Mini-Sentinel, joined by the data repositories of several major health systems in the US, has been able to compile a database of over 150 million individual (but de-identified) health records; this database has been used successfully to verify the risks of several drugs and medical treatments. The ability to pull together disparate data sources and use them (but without changing the location or ownership of the original data) was also demonstrated.

One direct offshoot of Mini-Sentinel is that some of the same participants, inside and outside FDA, will be part of a joint effort between FDA, the Reagan-Udall Foundation for the FDA [an independent 501(c)3 organization set up by Congress] and the Patient Centered Outcomes Research Institute (PCORI, another independent nonprofit set up by Congress—but one that started with several hundred million dollars of federal money to devote to outcomes research). This nonprofit mashup is called Innovation in Medical Evidence Development Surveillance (IMEDS). IMEDS has just released its own research agenda. Another part of the Reagan-Udall Foundation program has operated under the name Observational Medical Outcomes Partnership (OMOP); and of course all of these activities parallel, complement or encroach on what is supposed to be happening at the Agency for Healthcare Research and Quality (AHRQ). For the pharma industry, there’s a chance that this can all come together in a meaningful way to provide good methods for conducting observational studies, health outcomes research and pharmacovigilance; but there’s also a chance that each part will continue in its own direction.