TL03: Adaptive Design’s Past, Current, and Future
*Xiaoyin (Frank) Fan, Vertex Pharmaceutical 


Adaptive design (AD) has evolved a long way from just a few specific types of designs to a more inclusive collection of innovative trial designs. Its usefulness has also been well recognized in the pharmaceutical industry. This round table discussion is intended to discuss the following topics: •To share program or portfolio level approaches of using AD among pharmaceutical companies. For example: o How much effort/resource is invested in the developing and considering AD in trials; o Roughly how popular AD is in late-stage trials among different therapeutic areas and trial phases; o How to balance the need to be adaptive in conducting the trial and the challenges in operational implementations plus difficulties in interpretation of the results; o What are the practices to engage with regulatory agencies when considering AD; • To learn about some feedback to the recent FDA draft guidance for Industry, particularly with regard to any changes in their approaches and practices in design and/or conduct of AD trials (2010)