An optimal sequential design in ethical allocation with an adaptive interim analysis

Abstract

The present article provides a distribution-free test procedure for comparing the effectiveness of two competing treatments A and B, say, in a clinical trial. Here, the relative treatment effect is measured by the functional $\theta =P(X<Y)$, where X and Y are respectively the response variables corresponding to two treatments, A and B. The treatment comparison is done through a testing of hypothesis regarding θ under a patient-benefit oriented two-stage response-adaptive design with an interim analysis in which an optimal sequential sampling scheme with equal randomisation is adopted in stage 1 and a response-adaptive randomisation is employed in stage 2 with the objective of allocating more patients to more promising treatment. The performance of the proposed procedure is compared with that of various other competitive procedures.

Keywords:

• Clinical trial
• ethical allocation
• interim analysis
• patient-benefit consideration and response adaptive design

Acknowledgments

The author is very grateful to the Associate Editor and two anonymous referees for their constructive comments on the manuscript which help to make the final version more enriched and informative.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The author is also thankful to the authority of Presidency University, Kolkata for providing the financial support under the FRPDF Scheme.