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Sample Size Re-Estimation for Adaptive Sequential Design in Clinical Trials |
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| Authors: | Ping Gao James H. Ware Cyrus Mehta |
| Affiliation: | 1. Biostatistics , The Medicines Company , Parsippany, New Jersey, USA ping.gao@themedco.com;3. Harvard School of Public Health , Boston, Massachusetts, USA;4. Harvard School of Public Health , Boston, Massachusetts, USA;5. Cytel Corporation , Cambridge, Massachusetts, USA |
| Abstract: | There is considerable interest in methods that use accumulated data to modify trial sample size. However, sample size re-estimation in group sequential designs has been controversial. We describe a method for sample size re-estimation at the penultimate stage of a group sequential design that achieves specified power against an alternative hypothesis corresponding to the current point estimate of the treatment effect. |
| Keywords: | Adaptive design Brownian motion Conditional power Markov process Sample size re-estimation Sequential design Transition function |