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A Regulatory View on Adaptive/Flexible Clinical Trial Design
Author(s) -
Hung H. M. James,
O'Neill Robert T.,
Wang SueJane,
Lawrence John
Publication year - 2006
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.200610229
Subject(s) - adaptive design , computer science , econometrics , mathematics , risk analysis (engineering) , clinical trial , medicine
Recently there is growing interest in use of adaptive or flexible designs for development of pharmaceutical products. Statistical methodology has been greatly advanced in the literature. However, there are still some important issues with the methodology and application. In addition, there are many other challenges with these designs, including efficiency of these designs in the entire development program, trial conduct and logistics, the infrastructure of an adaptive trial, the regulatory evaluation of trial results and trial conduct, etc. Up till now, regulatory experience in these designs is very limited. We share some of the challenges. (© 2006 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)