Adaptive Selection Designs in Regulatory Applications
*James Hung, FDA Keywords: adaptive selection, interim analysis, multi-stage design In the recent decade statistical literature is enriched by a good number of adaptive design methods which are proposed particularly for applications of clinical trials. Of these designs, adaptive selection designs appear to be increasingly seen in regulatory applications, such as selection of a subgroup of patients to target for statistical testing, selection of dosing regimens for study. The selection may be based on some marker(s) or clinical endpoint(s). This presentation will pinpoint the essential features of such designs and their potential utilities and pitfalls. In fact, such designs are special cases of multi-stage designs. A number of case examples will be used for illustration.
|
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