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On Optimal Designs for Clinical Trials: An Updated Review
Novartis Pharmaceut, Early Dev Biostat, E Hanover, NJ USA.
Uppsala University, Disciplinary Domain of Science and Technology, Mathematics and Computer Science, Department of Mathematics, Applied Mathematics and Statistics. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.ORCID iD: 0000-0003-2997-856
Univ Calif Los Angeles, Fielding Sch Publ Hlth, Dept Biostat, Los Angeles, CA 90095 USA.
2020 (English)In: Journal of Statistical Theory and Practice, ISSN 1559-8608, E-ISSN 1559-8616, Vol. 14, no 1, article id 10Article, review/survey (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
SPRINGER , 2020. Vol. 14, no 1, article id 10
Keywords [en]
Estimation efficiency, Dose-finding, Multiple comparisons and modeling, Optimal response-adaptive randomization, Phase I, II studies, Population PK, PD studies, Power
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-407110DOI: 10.1007/s42519-019-0073-4ISI: 000511595400001OAI: oai:DiVA.org:uu-407110DiVA, id: diva2:1415672
Available from: 2020-03-19 Created: 2020-03-19 Last updated: 2020-03-19Bibliographically approved

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Ryeznik, Yevgen

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