ADSWG Best Practice Sub Team: Objectives to support increased use of Adaptive Trial Designs
*David Michael Moriarty, Janssen Research & Development 

Keywords: Adaptive Design, ADSWG, Implementation, Model System

The prevalence of adaptive trial designs (AD) remains lower than their proponents in industry and regulatory agencies would desire. Analysis by Tufts CSDD has identified that complexity in multiple disciplines is viewed as a barrier to implementation. The DIA ADSWG has formed a sub team focused on promoting best practices to promote greater use of AD trials in development programs across industry. The team is comprised of people from a range of disciplines across industry and regulatory agencies. The goal of the sub team is to clarify, and provide guidance in response to, the concerns heard around the practical implementation of AD trials. There are real and perceived barriers to implementation; the team is to address those concerns and the more significant issues through the use of proposed model systems and communication plans. Articulating a perspective on an optimal model to support AD trial design and implementation will increase understanding and remove barriers to implementation. In addition, the sub team is focused on gaining further clarity on regulatory agency perspective on designs currently viewed as ‘less well understood AD designs’ and how to move the position on them to ‘more well accepted AD designs’.