Dose-Finding and Dose-Ranging Studies

Mark R. Conaway () and Gina R. Petroni ()
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Mark R. Conaway: University of Virginia Health System
Gina R. Petroni: University of Virginia Health System, Translational Research and Applied Statistics, Public Health Sciences

Chapter 53 in Principles and Practice of Clinical Trials, 2022, pp 951-971 from Springer

Abstract: Abstract There is a growing recognition of the importance of well-designed dose-finding studies in the overall development process. This chapter is an overview of designs for studies that are meant to identifying one or more doses of an agent to be tested in subsequent stages of the drug development process. The chapter also provides a summary of dose-finding designs that have been developed to meet the challenges of contemporary dose-finding trials, including the use of combinations of agents, more complex outcome measures, and heterogeneous groups of participants.

Keywords: Interval-based methods; Model-based methods; Operating characteristics; Coherence; Combinations of agents; Patient heterogeneity (search for similar items in EconPapers)
Date: 2022
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-319-52636-2_77

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DOI: 10.1007/978-3-319-52636-2_77

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