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进行多项II期研究的整合试验的优势。

Advantages of integrated trials for performing multiple Phase II studies.

作者信息

Weiss G B, Hokanson J A

出版信息

Invest New Drugs. 1984;2(4):409-14. doi: 10.1007/BF00171595.

DOI:10.1007/BF00171595
PMID:6511244
Abstract

Phase II trials can be conducted in an integrated fashion that minimizes assignment of patients to potentially ineffective treatments. The technique allows definitions of response to include survival; earlier identification of more effective drugs; and completion of more Phase II studies in a given time period. It also encourages investigators to analyse results promptly. Because the analysis of each trial is independent, the statistical power of the analysis of results is retained. Identified shortcomings of the method include the need for a central mechanism to assign patients to treatment, the need for several drugs to be tested, physicians' uncertainty about which drug a particular patient will receive, and the increased time it may take to complete an individual trial.

摘要

II期试验可以以一种综合方式进行,这种方式能将患者分配到潜在无效治疗的情况降至最低。该技术允许将反应的定义包括生存情况;更早地识别出更有效的药物;并在给定时间段内完成更多的II期研究。它还鼓励研究人员迅速分析结果。由于每个试验的分析都是独立的,所以结果分析的统计效力得以保留。该方法已确定的缺点包括需要一个中央机制来将患者分配到治疗组、需要测试几种药物、医生不确定特定患者将接受哪种药物,以及完成单个试验可能需要更长时间。

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本文引用的文献

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