Journal
BIOMETRICAL JOURNAL
Volume 48, Issue 4, Pages 565-573Publisher
WILEY
DOI: 10.1002/bimj.200610229
Keywords
statistical information; adaptive information design; superiority; non-inferiority; dropping a treatment arm; statistical efficiency; regulatory evaluation
Funding
- DRS NIH HHS [RSR 5-04, RSR 04-06] Funding Source: Medline
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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.
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