Limitations of adaptive clinical trials.
Adaptive designs are aimed at introducing flexibility in clinical research by allowing important characteristics of a trial to be adapted during the course of the trial based on data coming from the trial itself. Adaptive designs can be used in all phases of clinical research, from phase I to phase III. They tend to be especially useful in early development, when the paucity of prior data makes their flexibility a key benefit. The need for adaptive designs lessened as new treatments progress to later phases of development, when emphasis shifts to confirmation of hypotheses using fully prespecified, well-controlled designs.
From the International Drug Development Institute, Houston, TX; Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Diepenbeek, Belgium.
Marc
M
Buyse