Regulatory Perspectives of Adaptive Design Throughout Drug Developments
*Sue-Jane Wang, FDA Keywords: adaptive design; draft guidance In light of the recently published US FDA draft guidance for industry on adaptive design clinical trials for drugs and biologics, the interests to pursue adaptive design seem increasing. The publication has also allowed us to take a fresh look of other designs including fixed designs, group sequential designs and a broader class of flexible designs. In this commentary, regulatory perspectives from review experiences will be shared. Typical case examples may be used to highlight the thought process of an adaptive design consideration in clinical development programs.
|
Key Dates
-
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC