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终止一项长期临床试验。

Terminating a long-term clinical trial.

作者信息

Klimt C R

出版信息

Control Clin Trials. 1981 May;1(4):319-25. doi: 10.1016/0197-2456(81)90035-0.

DOI:10.1016/0197-2456(81)90035-0
PMID:7261622
Abstract

Long-term clinical trials often include more than one active treatment group. These may be discontinued independently if found to be ineffective or possibly harmful. Certain subgroups of patients may be discovered, in the course of a clinical trial, who do not respond satisfactorily and are, therefore, excluded during the course of a trial. Yet another kind of termination comes when we have a therapeutic breakthrough or when hope has to be abandoned for demonstrating beneficial effects for one, several, or all treatments included in a trial. Examples from the authors' experience are presented, as are successful and unsuccessful techniques in managing terminations of various types.

摘要

长期临床试验通常包括不止一个活性治疗组。如果发现这些治疗组无效或可能有害,可独立终止。在临床试验过程中,可能会发现某些患者亚组对治疗反应不佳,因此在试验过程中被排除。当我们取得治疗突破,或者不得不放弃证明试验中一种、几种或所有治疗具有有益效果的希望时,就会出现另一种终止情况。文中介绍了作者经验中的实例,以及处理各类终止情况的成功和不成功技巧。

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