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Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers.

Research output: Contribution to journalJournal article

Published

Journal publication date03/2008
JournalBiometrics
Journal number1
Volume64
Number of pages10
Pages299-308
Original languageEnglish

Abstract

Summary. Bayesian decision procedures have recently been developed for dose escalation in phase I clinical trials concerning pharmacokinetic responses observed in healthy volunteers. This article describes how that general methodology was extended and evaluated for implementation in a specific phase I trial of a novel compound. At the time of writing, the study is ongoing, and it will be some time before the sponsor will wish to put the results into the public domain. This article is an account of how the study was designed in a way that should prove to be safe, accurate, and efficient whatever the true nature of the compound. The study involves the observation of two pharmacokinetic endpoints relating to the plasma concentration of the compound itself and of a metabolite as well as a safety endpoint relating to the occurrence of adverse events. Construction of the design and its evaluation via simulation are presented.

Bibliographic note

RAE_import_type : Journal article RAE_uoa_type : Statistics and Operational Research