Biostatistical methods for demonstrating efficacy in the regulatory setting. An epistemological approach to adaptive designs.
Adaptive designs are one of the most promising developments in statistics with applications to clinical trials. Obviously the knowledge at the beginning of a clinical trial will always be limited. In consequence it may be considered necessary 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 principle aim is confirmation of hypotheses that have been developed in earlier stages of drug development.
Koch
A
A
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn. a.koch@bfarm.de
D001699:Biometry; D002986:Clinical Trials as Topic / Q000379:methods*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D006801:Humans; D010684:Philosophy; D011897:Random Allocation; D012107:Research Design