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An adaptive design for categorical responses in Phase III clinical trials

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TLDR
It is illustrated that the proposed design is an improvement over the existing design of Bandyopadhyay and Biswas for such categorical responses in terms of low variability for phase III clinical trials where the treatment responses are categorical.
Abstract
An adaptive design is provided for phase III clinical trials where the treatment responses are categorical. The proposed design extends the drop-the-loser rule (Ivanova [10]) which is proposed for binary treatment responses only. It is illustrated that the proposed design is an improvement over the existing design of Bandyopadhyay and Biswas [3] for such categorical responses in terms of low variability. Some probability generating functions of the proposed design are obtained. The applicability of the proposed design is illustrated by using some real data from an trial of patients of rheumatoid arthritis.

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Citations
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Journal ArticleDOI

A response adaptive design for ordinal categorical responses.

TL;DR: A two treatment response adaptive design is developed for phase III clinical trials with ordinal categorical treatment outcome using Goodman-Kruskal measure of association.
Journal ArticleDOI

A multi-treatment response adaptive design for ordinal categorical responses.

TL;DR: For practical implementation, the proposed response-adaptive randomization (RAR) is suggested, that is, update the allocation probabilities dynamically using the available allocation and response information to favor the treatment doing better.
Journal ArticleDOI

A response adaptive design for ordinal categorical responses weighing the cumulative odds ratios

TL;DR: In this paper, a two treatment response adaptive design for phase III clinical trial is proposed for ordinal categorical responses, which weighs the cumulative odds ratios suitably, and proposes a two-treatment response adaptive scheme.
Journal ArticleDOI

An optimal response adaptive design for multi-treatment clinical trials with ordinal categorical outcomes.

TL;DR: In clinical trials, fixed randomizations in a prefixed proportion (e.g. 1:1 or 2:1 for two treatment trials) may be adopted to allocate the entering patients among the competing treatments as mentioned in this paper.
Journal ArticleDOI

Multi-arm covariate adjusted response adaptive designs for ordinal outcome clinical trials

TL;DR: Covariate adjusted response adaptive designs with ordinal categorical responses for phase III clinical trial involving multiple treatments are developed in this paper , where stochastic ordering principle is used to order the treatments according to effectiveness and consequently allocation functions are developed by combining the cumulative odds ratios suitably.
References
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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.
Journal ArticleDOI

Extracorporeal circulation in neonatal respiratory failure: A prospective randomized study

TL;DR: A prospective controlled randomized study of the use of extracorporeal membrane oxygenation to treat newborns with respiratory failure using the "randomized play-the-winner" statistical method, which allows lung rest and improves survival compared to conventional ventilator therapy in newborn infants with severe respiratory failure.
Journal ArticleDOI

The Randomized Play-the-Winner Rule in Medical Trials

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