Apply response adaptive randomization to group sequential with early stopping

Fei Jiang, The University of Texas School of Public Health


Group sequential methods and response adaptive randomization (RAR) procedures have been applied in clinical trials due to economical and ethical considerations. Group sequential methods are able to reduce the average sample size by inducing early stopping, but patients are equally allocated with half of chance to inferior arm. RAR procedures incline to allocate more patients to better arm; however it requires more sample size to obtain a certain power. This study intended to combine these two procedures. We applied the Bayesian decision theory approach to define our group sequential stopping rules and evaluated the operating characteristics under RAR setting. The results showed that Bayesian decision theory method was able to preserve the type I error rate as well as achieve a favorable power; further by comparing with the error spending function method, we concluded that Bayesian decision theory approach was more effective on reducing average sample size.

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Recommended Citation

Jiang, Fei, "Apply response adaptive randomization to group sequential with early stopping" (2009). Texas Medical Center Dissertations (via ProQuest). AAI1470102.