Choice of designs and doses for early phase trials.

Abstract:

:This paper reviews state-of-art statistical designs for dose-escalation procedures in first-into-man studies. The main focus will be on studies in oncology, as most statistical procedures for phase I trials have been proposed in this context. Extensions to situations such as the observation of bivariate outcomes and healthy volunteer studies are also discussed. The number of dose levels and cohort sizes used in early phase trials are considered. Finally, this paper raises some practical issues for dose-escalation procedures.

journal_name

Fundam Clin Pharmacol

authors

Zhou Y

doi

10.1111/j.1472-8206.2004.00226.x

subject

Has Abstract

pub_date

2004-06-01 00:00:00

pages

373-8

issue

3

eissn

0767-3981

issn

1472-8206

pii

FCP226

journal_volume

18

pub_type

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