| Olga Marchenko at i3 Statprobe explores the impact and potential challenges of adaptive designs in clinical trials
At the beginning of a clinical trial, knowledge about the compound understudy will always be limited. It seems logical, therefore, that the information from the trial itself can be useful in improving the trial design. Recent developments in the methodology of adaptive designs in clinical trials have the potential to improve the quality, speed and efficiency of drug development. While the increased flexibility of adaptive design methods has made this type of trial strategy increasingly attractive to clinical researchers and sponsors, these new statistical methods should never be used as a substitute for careful planning. This article discusses the types of adaptive design and their potential benefits and challenges.
INCREASED POPULARITY OF ADAPTIVE DESIGN
The number of publications in adaptive and flexible designs has increased significantly in recent years. Although the adaptive designs considered in most scientific papers are not widely used in practice, their theoretical popularity continues to grow. Several biostatistics journals have recently published special issues on adaptive designs, including a 2005 special issue in the Journal of Biopharmaceutical Statistics, and a special issue of the Biometrical Journal and the Journal of Statistical Planning and Inference in 2006. |
