New Clinical Trial Designs for Phase I Studies in Hematology and Oncology: Principles and Practice of the Continual Reassessment Model
作者:
A.-R. Hanauske,
L. Edler,
期刊:
Onkologie
(Karger Available online 1996)
卷期:
Volume 19,
issue 5
页码: 404-409
ISSN:0378-584X
年代: 1996
DOI:10.1159/000218841
出版商: S. Karger GmbH
关键词: Phase I design;Continual Reassessment Model;Hematology;Oncology
数据来源: Karger
摘要:
Clinical phase I studies in Hematology and Oncology are characterized by specific ethical and methodological considerations. Among these, the determination of a safe starting dose, the definition of dose escalation schemes and the strategies of cohort size expansion per dose level and toxicities observed are of crucial importance. This review will focus on the continual reassessment method, a novel Bayesian-based approach to the conceptual design of clinical phase I studies in Hematology and Oncology. The original method as described by O’Quigley et al. [Biometrics 1990;46:33-48] will be reviewed as well as modifications which are intended to increase patient safety. Finally, clinical applications of the modified Continual Reassessment Method will be discusse
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