Co-Chairs:  Stephen Marder, MD; Mauricio Tohen, MD

There are concerns that the current systems for assessing risks from pharmaceutical agents and devices may miss important adverse events. This is a special problem for relatively rare events that may not be detectable during Phase II-III or even phase IV controlled trials, but may emerge after a drug is out in the market and available to large, diverse populations used alone or in combination therapy.

This session will focus on approaches on drug safety that include improving the sensitivity of Phase 2 and 3 trials and approaches to post-marketing surveillance. Speakers will include individuals from the US FDA who will discuss the agency’s approaches to identifying risks from clinical trials; a pharmacoepidemiologist who will discuss the use of large clinical databases for identifying risks; a scientist from industry who will present on new and evolving approaches to detecting risks such as suicide which are common in psychiatric populations, and a clinical scientist from academia who will discuss approaches to assessing risk and benefits of pharmacological agents.