A Case Study of an Adaptive Clinical Trial in the Treatment of Out-Patients with Depressive Disorder
作者:
RoyN. Tamura,
DouglasE. Faries,
JohnS. Andersen,
JohnH. Heiligenstein,
期刊:
Journal of the American Statistical Association
(Taylor Available online 1994)
卷期:
Volume 89,
issue 427
页码: 768-776
ISSN:0162-1459
年代: 1994
DOI:10.1080/01621459.1994.10476810
出版商: Taylor & Francis Group
关键词: Adaptive trial;Play-the-winner;Randomization and Bayesian inference
数据来源: Taylor
摘要:
Adaptive clinical trials have attracted the attention of statisticians because they allow for information accrued early in the trial to influence the allocation of treatment of later enrolled patients, thus allowing those patients an increased likelihood of receiving the better treatment. Few adaptive clinical trials have been reported in the literature; the purpose of this article is to describe the rationale, design, and analysis of a recently completed adaptive trial. Simulations to address sample size issues are presented. A Bayesian and a frequentist randomization analysis are discussed. The randomization analysis addresses the use of an adaptive allocation scheme, a delayed response, and a surrogate response. In this trial, the differences between the Bayesian and randomization inference were small. Some suggestions for future implementation of adaptive clinical trials and future research areas are provided.
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