Journal ArticleDOI
Optimal response-adaptive designs for continuous responses in phase III trials.
TLDR
This paper illustrates that the Zhang and Rosenberger (2006) design is not suitable for normally distributed responses, in general, and proposes a unified framework to find optimal response-adaptive designs for two competing treatments.Abstract:
Optimal response-adaptive designs in phase III clinical trial set up are gaining more interest. Most of the available designs are not based on any optimal consideration. An optimal design for binary responses is given by Rosenberger et al. (2001) and one for continuous responses is provided by Biswas and Mandal (2004). Recently, Zhang and Rosenberger (2006) proposed another design for normal responses. This paper illustrates that the Zhang and Rosenberger (2006) design is not suitable for normally distributed responses, in general. The approach cannot be extended for other continuous response cases, such as exponential or gamma. In this paper, we first describe when the optimal design of Zhang and Rosenberger (2006) fails. We then suggest the appropriate adjustments for designs in different continuous distributions. A unified framework to find optimal response-adaptive designs for two competing treatments is proposed. The proposed methods are illustrated using some real data.read more
Citations
More filters
Journal ArticleDOI
Response-adaptive designs for continuous treatment responses in phase III clinical trials: A review.
Atanu Biswas,Rahul Bhattacharya +1 more
TL;DR: This paper attempts to explore the available response-adaptive randomization procedures together with a comparison of their performances, and some real-life adaptive trial is reviewed.
Journal ArticleDOI
Optimal response-adaptive designs for normal responses.
Atanu Biswas,Rahul Bhattacharya +1 more
TL;DR: The appropriate optimal response-adaptive design for normal or continuous distributions which provides the necessary correction for the ZR problem is provided.
Journal ArticleDOI
Multi-treatment optimal response-adaptive designs for phase III clinical trials
TL;DR: In this paper, a generalized framework is proposed to derive multi-treatment optimal response-adaptive designs for phase-III clinical trials, and a detailed performance study is provided for three treatment trials minimising failures.
Journal ArticleDOI
Familywise error control in multi-armed response-adaptive trials.
TL;DR: It is shown that the naïve z‐test can have an inflated type I error rate even after applying a Bonferroni correction, and there is a high price to pay in terms of power to guarantee familywise error control for randomization schemes with extreme allocation probabilities.
Journal ArticleDOI
Covariate-adjusted response-adaptive designs for longitudinal treatment responses: PEMF trial revisited.
TL;DR: A covariate-adjusted response-adaptive randomisation procedure is developed using the log-odds ratio within the Bayesian framework for longitudinal binary responses for binary treatment responses.
References
More filters
Book
Continuous univariate distributions
TL;DR: Continuous Distributions (General) Normal Distributions Lognormal Distributions Inverse Gaussian (Wald) Distributions Cauchy Distribution Gamma Distributions Chi-Square Distributions Including Chi and Rayleigh Exponential Distributions Pareto Distributions Weibull Distributions Abbreviations Indexes
Journal ArticleDOI
Generalized linear models. 2nd ed.
Peter McCullagh,John A. Nelder +1 more
TL;DR: A class of statistical models that generalizes classical linear models-extending them to include many other models useful in statistical analysis, of particular interest for statisticians in medicine, biology, agriculture, social science, and engineering.
Book
Group Sequential Methods with Applications to Clinical Trials
TL;DR: A short history of sequential and group sequential methods can be found in this paper, where the authors present a road map for the application of two-sided tests for comparing two treatments with normal response of known variance.
Journal ArticleDOI
Pregabalin for the treatment of postherpetic neuralgia A randomized, placebo-controlled trial
Robert H. Dworkin,Ann E. Corbin,J.P. Young,Uma Sharma,L. LaMoreaux,H. Bockbrader,E. A. Garofalo,R. M. Poole +7 more
TL;DR: Treatment of postherpetic neuralgia with pregabalin is safe, efficacious in relieving pain and sleep interference, and associated with greater global improvement than treatment with placebo.
Journal ArticleDOI
Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study.
Robert H. Bartlett,Dietrich W. Roloff,Richard G. Cornell,Andrews Af,Peter W. Dillon,Joseph B. Zwischenberger +5 more
TL;DR: In this paper, a prospective controlled randomized study of the use of extracorporeal membrane oxygenation to treat newborns with respiratory failure was carried out using the randomized play-the-winner statistical method, where the chance of randomly assigning an infant to one treatment or the other is influenced by the outcome of treatment of each patient in the study.