A two treatment response adaptive design is developed for phase III clinical trials with ordinal categorical treatment outcome using Goodman-Kruskal measure of association. Properties of the proposed design are studied both empirically and theoretically and the acceptability is further illustrated using two real data-sets; one from a clinical trial with trauma patients and the other from a trial with patients having rheumatoid arthritis. © 2018, © 2018 Taylor & Francis.

RAHUL BHATTACHARYA

Statistics

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University of Calcutta (informally known as Calcutta University or CU) is a collegiate public state university located in Kolkata, West Bengal, India.&nbsp;Within India it is recognized as a &quot;Five-Star University&quot; and accredited &quot;A&quot; Grade by National Assessment and Accreditation Council.

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The University of Calcutta has secured the Fifth position among the Universities of India in the prestigious &quot;Indian University Ranking 2019&quot; list, released by the NIRF of the Ministry of Human Resource Development, Government of India.

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It was established on 24 January 1857, and was one of the first institutions in Asia to be established as a multidisciplinary and Western-style university. Its alumni and faculty include several heads of state, heads of government, social reformers, prominent artists, only academy award winner and Dirac medal winner in India, many Fellows of the Royal Society and five Nobel laureates as of 2019 which is highest in South Asia.

University Of Calcutta

A response adaptive design for ordinal categorical responses.

Journal of Biopharmaceutical Statistics

A multi-treatment response adaptive procedure is developed considering “comparison with the best” philosophy of multiple comparison procedures for clinical trials with ordinal categorical responses, when there is no shared control. For each response category, we arbitrarily create two outcome groups; one by combining the categories more favorable to it and the other by merging the categories at most as favorable to it and hence define the odds (i.e. cumulative odds). Pairwise ratios of such odds (i.e. cumulative odds ratios) based on pairs of treatments are combined conveniently to derive a measure of relative superiority and hence the allocation probability functions. For practical implementation, we suggest response-adaptive randomization (RAR), that is, update the allocation probabilities dynamically using the available allocation and response information to favor the treatment doing better. Empirical as well as large sample properties following the randomization are investigated in detail. Moreover, a real clinical trial with trauma patients is redesigned using the proposed RAR to envisage practical applicability. © The Author(s) 2019.

Journal	Data powered by TypesetJournal of Biopharmaceutical Statistics
Publisher	Data powered by TypesetTaylor and Francis Inc.
ISSN	1054-3406
Open Access	No