On Optimal Designs for Clinical Trials: An Updated Review

Oleksandr Sverdlov, Yevgen Ryeznik, Weng Kee Wong

研究成果: Article同行評審

12 引文 斯高帕斯(Scopus)


Optimization of clinical trial designs can help investigators achieve higher quality results for the given resource constraints. The present paper gives an overview of optimal designs for various important problems that arise in different stages of clinical drug development, including phase I dose–toxicity studies; phase I/II studies that consider early efficacy and toxicity outcomes simultaneously; phase II dose–response studies driven by multiple comparisons (MCP), modeling techniques (Mod), or their combination (MCP–Mod); phase III randomized controlled multi-arm multi-objective clinical trials to test difference among several treatment groups; and population pharmacokinetics–pharmacodynamics experiments. We find that modern literature is very rich with optimal design methodologies that can be utilized by clinical researchers to improve efficiency of drug development.

期刊Journal of Statistical Theory and Practice
出版狀態Published - 2020 3月 1

All Science Journal Classification (ASJC) codes

  • 統計與概率


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