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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, Canner P L

出版信息

Clin Pharmacol Ther. 1979 May;25(5 Pt 2):641-6. doi: 10.1002/cpt1979255part2641.

DOI:10.1002/cpt1979255part2641
PMID:373946
Abstract

Long-term trials often include more than one active treatment group. These may be discontinued independently if found 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 anouther 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

长期试验通常包括不止一个活性治疗组。如果发现无效或可能有害,这些组可能会被独立终止。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,因此会在试验过程中被排除。然而,当我们取得治疗突破,或者不得不放弃对试验中一种、几种或所有治疗方法显示有益效果的希望时,就会出现另一种终止情况。文中列举了作者经验中的例子,以及处理各种类型终止情况的成功和不成功的技巧。

相似文献

1
Terminating a long-term clinical trial.终止一项长期临床试验。
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):641-6. doi: 10.1002/cpt1979255part2641.
2
Terminating a long-term clinical trial.终止一项长期临床试验。
Control Clin Trials. 1981 May;1(4):319-25. doi: 10.1016/0197-2456(81)90035-0.
3
When and how to stop a clinical trial: invited remarks.何时以及如何终止一项临床试验:特邀评论
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):651-4.
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When and how to stop a clinical trial: invited remarks.何时以及如何终止一项临床试验:特邀评论
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):647-8.
5
When and how to stop a clinical trial: invited remarks.何时以及如何终止一项临床试验:特邀评论
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):649-50.
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Terminating a trial -- the ethical problem.终止试验——伦理问题。
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):633-40. doi: 10.1002/cpt1979255part2633.
7
Communications: Should mechanisms be established for sharing among clinical trial investigators experiences in handling problems in design, execution, and analysis? Problems of omission in communications.交流:是否应建立机制,让临床试验研究者分享在设计、实施和分析中处理问题的经验?交流中的遗漏问题。
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):761-4.
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Proceedings of the National Conference on Clinical Trials Methodology.全国临床试验方法学会议论文集
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):629-766.
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Problems in publication of clinical trial methodology.
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):751-3. doi: 10.1002/cpt1979255part2751.
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Ethical considerations in clinical trials: invited remarks.临床试验中的伦理考量:特邀演讲
Clin Pharmacol Ther. 1979 May;25(5 Pt 2):742-6.

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