Articles
Adaptive Trial Designs In Late Phase Drug Development
March 4, 2008
•Article: Adaptive Trial Designs In Late Phase Drug Development
Written and compiled by Alan J. Phillips, Director Biostatistics, ICON Clinical Research
Before regulatory agencies approve a new drug, they require substantial evidence of the effectiveness and safety through clinical trials. Most clinical trials are static in nature and designated as Phase I, II, or III based on the type of questions that the trial is seeking to answer. With increasing pressure to bring drugs to market faster and more cheaply, the current development paradigm is being challenged. One particular area receiving a great deal of attention is "Adaptive Designs." That is, methods that allow for major design modifications of ongoing clinical trials, but which comply with good statistical practice. The advantage of such designs is that critical decisions can be made much earlier, and therefore development costs and time to market are reduced.
This paper will outline the key statistical considerations that need to be addressed when utilizing adaptive designs in late phase drug development. Five application areas, one of which includes a case study, will be presented. A review of some of the different adaptive design practices will be presented, together with a discussion of the acceptability of the proposed techniques based on the draft reflection paper.
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