Adaptive biased‐coin designs for skewing the allocation proportion in clinical trials with normal responses

Response adaptive designs are used in phase III clinical trial for skewing the allocation pattern towards the better treatments. We use optimum design theory to derive adaptive designs when the responses are normally distributed. The performance of the designs is studied with respect to the loss and the proportion of allocation to different treatments. The adaptive design does not affect inference.

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

[2]  Richard L. Smith Properties of Biased Coin Designs in Sequential Clinical Trials , 1984 .

[3]  L. J. Wei,et al.  The Randomized Play-the-Winner Rule in Medical Trials , 1978 .

[4]  B. Efron Forcing a sequential experiment to be balanced , 1971 .

[5]  A. Atkinson,et al.  The distribution of loss in two-treatment biased-coin designs. , 2003, Biostatistics.

[6]  Uttam Bandyopadhyay,et al.  Adaptive designs for normal responses with prognostic factors , 2001 .

[7]  D. R. Cox,et al.  A note on design when response has an exponential family distribution , 1988 .

[8]  A. Atkinson Optimum biased coin designs for sequential clinical trials with prognostic factors , 1982 .

[9]  Alessandra Giovagnoli,et al.  On the Large Sample Optimality of Sequential Designs for Comparing Two or More Treatments , 2005 .

[10]  Colin B. Begg,et al.  On inferences from Wei's biased coin design for clinical trials , 1990 .

[11]  M. Zelen,et al.  Play the Winner Rule and the Controlled Clinical Trial , 1969 .

[12]  Richard L. Smith Sequential Treatment Allocation Using Biased Coin Designs , 1984 .

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

[14]  Anthony C. Atkinson,et al.  Adaptive biased-coin designs for clinical trials with several treatments , 2023, Discussiones Mathematicae Probability and Statistics.

[15]  R. G. Cornell,et al.  Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study. , 1985, Pediatrics.

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

[17]  C. Rout,et al.  A Reevaluation of the Role of Crystalloid Preload in the Prevention of Hypotension Associated with Spinal Anesthesia for Elective Cesarean Section , 1993, Anesthesiology.

[18]  S. D. Durham,et al.  A sequential design for maximizing the probability of a favourable response , 1998 .

[19]  Douglas E. Faries,et al.  A Case Study of an Adaptive Clinical Trial in the Treatment of Out-Patients with Depressive Disorder , 1994 .

[20]  Atanu Biswas,et al.  Bayesian Adaptive Biased‐Coin Designs for Clinical Trials with Normal Responses , 2005, Biometrics.

[21]  Anthony C. Atkinson,et al.  The comparison of designs for sequential clinical trials with covariate information , 2002 .

[22]  Isabella Verdinelli,et al.  Biased coin designs with a Bayesian bias , 1993 .