Journal
DRUG INFORMATION JOURNAL
Volume 43, Issue 6, Pages 713-723Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/009286150904300609
Keywords
Adaptive design; Data monitoring committee report; Simulation report; Response-adaptive allocation; Trial simulation
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The planning and execution of clinical trials utilizing response-adaptive allocation involves complexities beyond those encountered in the planning and execution of more traditional trial designs. How the adaptive design will optimize the drug development process must be clearly defined; an appropriate endpoint must be selected to drive the adaptive design engine, and steps must be taken to ensure that the data required for adaptive decision making will be available in a timely fashion during the trial. Trial simulations are essential during the planning stage to develop appropriate decision rules and the response-adaptive allocation algorithm. Structures such as data monitoring committees and independent statistical centers help to ensure the validity and integrity of the trial, while facilitating decision making during the trial.
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