Silver Linings Playbook: The Positive Side of Negative Trials

Co-chairs: Richard Keefe, PhD; Steven Romano, MD

Late phase clinical trials are conducted to confirm results from earlier phase activities and are thus expected to have a substantially higher probability of success.  But failures in these pivotal registration trials do occur, and often lead to program cancellation.  Regardless of whether a particular program advances or is discontinued following negative trial results, there are important methodological lessons that can be extracted to inform future research endeavors.  This session will first highlight the need to adhere to disciplined early phase drug development fundamentals in order to diffuse risk and increase probability of later phase success.  Next, specific results and challenges from a number of late phase programs in both psychiatry and neurology will be discussed, with opportunities to review what was learned and what options can be considered for future investment.  A panel discussion will cover a range of stakeholder viewpoints, including regulatory, industry sponsors and clinical research organizations.