Postmarket Surveillance Issues

• Activity Number: 530
• Type: Roundtables
• Date/Time: Wednesday, August 1, 2012 : 12:30 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Theodore Lystig*+
• Companies: Medtronic
• Keywords: surveillance ; signal detection ; medical devices ; pharmaceuticals ; biologics ; regulatory

Abstract

There is increasing recognition that even after a medical therapy has gained regulatory approval, there is a need for structured data collection and analysis in the post-approval (also called postmarket) space. Such data has historically been collected primarily through passive systems (including national registries by disease or therapy), but more recent work has been proposed and performed using active surveillance systems. Many efforts in this area are being coordinated through FDA's Sentinel Initiative, the Observational Medical Outcomes Partnership (OMOP), and the Medical Device Epidemiology Network (MDEpiNet). Postmarket data may also be collected through postmarket required studies (PMR), postmarket commitment studies (PMS), or post-approval studies (PAS). Challenges in design and analysis in this area include working with (possibly) single arm studies, designing studies from an estimation viewpoint instead of a testing one, determining how to aggregate data from multiple different sources, and performing signal detection on indicators of safety or of efficacy. This roundtable will provide an opportunity for participants to discuss recent work in this exciting area.