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’.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC