The next generation of trial design innovation: strategies, methods and logistical considerations for flexible trial designs

Loews Philadelphia Hotel, Philadelphia, PA, USA, 15–16 November 2012 The US FDA’s critical path initiative is a national strategy to drive innovation in the scientific processes, through which medical products are developed, evaluated and manufactured. Launched in 2004, and followed in 2006 by the Critical Path Opportunities List, it lists several areas where technology and systems could improve the accuracy of tests that predict the safety and efficacy of potential medical products. Adaptive clinical trial design is one of the major components of the critical path, and in 2010, the FDA issued its draft Guidelines. The Next Generation of Trial Design Innovation Conference had invited several industry experts, and the focus was to explore strategies, methods and logistical considerations for flexible trial designs at the study, product and portfolio level.