Response-Adaptive Randomization for Survival Trials: The Parametric Approach
- 1 March 2007
- journal article
- Published by Oxford University Press (OUP) in Journal of the Royal Statistical Society Series C: Applied Statistics
- Vol. 56 (2), 153-165
- https://doi.org/10.1111/j.1467-9876.2007.00571.x
Abstract
Summary: Few references deal with response-adaptive randomization procedures for survival outcomes and those that do either dichotomize the outcomes or use a non-parametric approach. In this paper, the optimal allocation approach and a parametric response-adaptive randomization procedure are used under exponential and Weibull distributions. The optimal allocation proportions are derived for both distributions and the doubly adaptive biased coin design is applied to target the optimal allocations. The asymptotic variance of the procedure is obtained for the exponential distribution. The effect of intrinsic delay of survival outcomes is treated. These findings are based on rigorous theory but are also verified by simulation. It is shown that using a doubly adaptive biased coin design to target the optimal allocation proportion results in more patients being randomized to the better performing treatment without loss of power. We illustrate our procedure by redesigning a clinical trial.Keywords
This publication has 14 references indexed in Scilit:
- Implementing Optimal Allocation in Sequential Binary Response ExperimentsJournal of the American Statistical Association, 2007
- Response‐Adaptive Randomization for Clinical Trials with Continuous OutcomesBiometrics, 2005
- Randomized Phase III Study of Docetaxel Compared With Paclitaxel in Metastatic Breast CancerJournal of Clinical Oncology, 2005
- Asymptotic properties of doubly adaptive biased coin designs for multitreatment clinical trialsThe Annals of Statistics, 2004
- Optimal Adaptive Designs in Phase III Clinical Trials for Continuous Responses with CovariatesPublished by Springer Science and Business Media LLC ,2004
- Optimality, Variability, PowerJournal of the American Statistical Association, 2003
- Optimal Adaptive Designs for Binary Response TrialsBiometrics, 2001
- An adaptive randomized design with application to estimationThe Canadian Journal of Statistics / La Revue Canadienne de Statistique, 2001
- Adaptive survival trialsJournal of Biopharmaceutical Statistics, 1997
- LOGRANK, PLAY THE WINNER, POWER AND ETHICSStatistics in Medicine, 1996