Adaptive Multiple Comparison Sequential Design (AMCSD) for clinical trials

ABSTRACT

We propose an adaptive sequential testing procedure for clinical trials that test the efficacy of multiple treatment options, such as dose/regimen, different drugs, sub-populations, endpoints, or a mixture of them in one trial. At any interim analyses, sample size re-estimation can be conducted, and any option can be dropped for lack of efficacy or unsatisfactory safety profile. Inference after the trial, including p-value, conservative point estimate and confidence intervals, are provided.

KEYWORDS:

• Brownian motion approximation
• multiple comparison
• adaptive sequential design
• sample size re-estimation
• treatment selection

Acknowledgements

The authors would like to thank the reviewers for helpful and constructive comments.

Disclosure statement

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

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/10543406.2023.2233590.

Additional information

Funding

The authors reported there is no funding associated with the work featured in this article.