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

ABSTRACT

Weighing the cumulative odds ratios suitably, a two treatment response adaptive design for phase III clinical trial is proposed for ordinal categorical responses. Properties of the proposed design are investigated theoretically as well as empirically. Applicability of the design is further verified using a data pertaining to a real clinical trial with trauma patients, where the responses are observed in an ordinal categorical scale.

KEYWORDS:

• Response adaptive design
• ordinal categorical responses
• cumulative odds ratio

Acknowledgments

The authors thank the anonymous reviewers, the Editor, and the Associate Editor for their insightful comments which led to an improvement over the earlier version of this work.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The research of the third author is partially supported by a research fellowship (Ref. No. 21/06/2015(i)EU-V) sponsored by the University Grants Commission, India.

Notes on contributors

Atanu Biswas

Atanu Biswas, is a professor (Higher Academic Grade) in the Applied Statistics Unit at the Indian Statistical Institute, Kolkata, India.

Rahul Bhattacharya

Rahul Bhattacharya, is a professor in the Department of Statistics at the University of Calcutta, Kolkata, India.

Soumyadeep Das

Soumyadeep Das, is an assistant professor in the Department of Statistics at Bidhannagar Government College, Kolkata, India.