A new family of covariate-adjusted response adaptive designs and their properties

It is often important to incorporate covariate information in the design of clinical trials. In literature there are many designs of using stratification and covariate-adaptive randomization to balance certain known covariate. Recently, some covariate-adjusted response-adaptive (CARA) designs have been proposed and their asymptotic properties have been studied (Ann. Statist. 2007). However, these CARA designs usually have high variabilities. In this paper, a new family of covariate-adjusted response-adaptive (CARA) designs is presented. It is shown that the new designs have less variables and therefore are more efficient.

[1]  W. R. Thompson ON THE LIKELIHOOD THAT ONE UNKNOWN PROBABILITY EXCEEDS ANOTHER IN VIEW OF THE EVIDENCE OF TWO SAMPLES , 1933 .

[2]  C. Assaid,et al.  The Theory of Response-Adaptive Randomization in Clinical Trials , 2007 .

[3]  W. Rosenberger,et al.  Randomization in Clinical Trials: Theory and Practice , 2002 .

[4]  William F. Rosenberger,et al.  Optimality, Variability, Power , 2003 .

[5]  Li-Xin Zhang,et al.  Asymptotic properties of covariate-adjusted response-adaptive designs , 2006 .

[6]  L. Hayre Two-population sequential tests with three hypotheses , 1979 .

[7]  J. Matthews,et al.  Randomization in Clinical Trials: Theory and Practice; , 2003 .

[8]  Feifang Hu,et al.  Asymptotic properties of doubly adaptive biased coin designs for multitreatment clinical trials , 2003 .

[9]  William F. Rosenberger,et al.  Implementing Optimal Allocation in Sequential Binary Response Experiments , 2007 .

[10]  Feifang Hu,et al.  ST ] 1 7 O ct 2 00 6 ASYMPTOTIC PROPERTIES OF COVARIATE-ADJUSTED ADAPTIVE DESIGNS , 2006 .

[11]  Michael Woodroofe,et al.  Central Limit Theorems for Doubly Adaptive Biased Coin Designs , 1995 .

[12]  P. Hall,et al.  Martingale Limit Theory and Its Application , 1980 .

[13]  H. Robbins Some aspects of the sequential design of experiments , 1952 .

[14]  D R Taves,et al.  Minimization: A new method of assigning patients to treatment and control groups , 1974, Clinical pharmacology and therapeutics.

[15]  M Zelen,et al.  The randomization and stratification of patients to clinical trials. , 1974, Journal of chronic diseases.

[16]  William F. Rosenberger,et al.  Asymptotically best response-adaptive randomization procedures , 2006 .

[17]  W. Stout Almost sure convergence , 1974 .

[18]  S. Pocock,et al.  Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. , 1975, Biometrics.

[19]  Feifang Hu,et al.  Asymptotic normality of urn models for clinical trials with delayed response , 2004 .

[20]  N Stallard,et al.  Optimal Adaptive Designs for Binary Response Trials , 2001, Biometrics.

[21]  Feifang Hu,et al.  Efficient randomized-adaptive designs , 2009, 0908.3435.

[22]  W. Rosenberger,et al.  The theory of response-adaptive randomization in clinical trials , 2006 .

[23]  W. Rosenberger,et al.  COVARIATE-ADJUSTED RESPONSE-ADAPTIVE DESIGNS FOR BINARY RESPONSE , 2001, Journal of biopharmaceutical statistics.

[24]  Feifang Hu,et al.  Optimal Adaptive Designs for Binary Response Trials With Three Treatments , 2010 .

[25]  William F. Rosenberger,et al.  Asymptotic Properties of Adaptive designs for Clinical Trials with delayed Response , 2002 .