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Choice of designs and doses for early phase trials
Author(s) -
Zhou Yinghui
Publication year - 2004
Publication title -
fundamental and clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.655
H-Index - 73
eISSN - 1472-8206
pISSN - 0767-3981
DOI - 10.1111/j.1472-8206.2004.00226.x
Subject(s) - bivariate analysis , context (archaeology) , medicine , medical physics , cohort , statistical analysis , phase (matter) , research design , clinical trial , computer science , statistics , mathematics , paleontology , biology , chemistry , organic chemistry
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.

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