Adaptive Design Studies: Operational and Regulatory Challenges
View Presentation *Lisa A Kammerman, AstraZeneca Keywords: adaptive design This talk describes operational and regulatory challenges associated with two-stage seamless adaptive design studies. The focus is on studies that are intended to provide the primary evidence of efficacy to support the approval of a medical product. Seamless adaptive designs are often touted for their potential to shorten product development time. However, the benefit of speed must be balanced against the risks of implementation errors, which this talk will highlight. Further, the results coming from adaptive design studies can be difficult to interpret. I will use a case study, crofelemer tablets (NDA 202-292), to illustrate these principles and to provide recommendations for future adaptive design studies.
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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