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Confirmatory Clinical Trials with an Adaptive Design
Author(s) -
Koch Armin
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.200510239
Subject(s) - clinical trial , adaptive design , computer science , drug development , principal (computer security) , clinical study design , medical physics , medicine , risk analysis (engineering) , management science , psychology , drug , engineering , pharmacology , pathology , operating system
Adaptive designs are one of the most promising developments in statistics with applications to clinical trials. Obviously, knowledge at the beginning of a clinical trial will always be limited. Thus it may seem logical that the knowledge from accumulating information should be used to optimize the design of the trial. This paper discusses conditions under which this may be possible in phase III clinical trials where the principal aim is confirmation of hypotheses that have been developed in earlier stages of drug development. (© 2006 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)