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

TLDR: In this paper , a distribution-free test procedure for comparing the effectiveness of two competing treatments A and B, say, in a clinical trial, is provided, where the relative treatment effect is measured by the functional θ=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 was employed in stage 2 with the objective of allocating more patients to more promising treatment.

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 θ=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.