Eur Heart J. 1994 Jun;15(6):721-38.
The early termination of clinical trials, for either benefit or harm, often generates undue enthusiasm or alarm. The enhanced publicity attending early termination of a trial promotes inappropriate interpretations because of the inherent difficulty of a prompt and comprehensive data review. Furthermore, the process of monitoring the accumulating outcome data for early evidence of treatment benefit or harm is fraught with many statistical and methodological difficulties. This report from a Task Force convened by the Working Group on Arrhythmias of the European Society of Cardiology incorporates first, a series of trials terminated appropriately or inappropriately for benefit or harm and used as examples to illustrate the importance of suitable trial design and of proper stopping rules; second, a description of the committee structure of a clinical trial; third, an analysis of the general design issues; fourth, a review of the main issues in interim analysis with special reference to main strategies for reducing the rate of false-positive claims that could result from early trial termination; and finally, a series of specific recommendations concerning the design, structure, analysis, interpretation, and presentation of a clinical trial.
临床试验因有益或有害而提前终止，往往会引发过度的热情或恐慌。由于迅速全面审查数据存在固有困难，试验提前终止时宣传力度的加大促使了不恰当的解读。此外，监测累积的结果数据以获取治疗有益或有害的早期证据这一过程充满了诸多统计和方法学上的困难。欧洲心脏病学会心律失常工作组召集的一个特别工作组撰写的这份报告，首先纳入了一系列因有益或有害而被适当或不适当终止的试验，并将其用作示例来说明合适的试验设计和恰当的停止规则的重要性；其次，描述了临床试验的委员会结构；第三，分析了总体设计问题；第四，回顾了中期分析中的主要问题，并特别提及降低因试验提前终止可能导致的假阳性声明发生率的主要策略；最后，针对临床试验的设计、结构、分析、解读和报告提出了一系列具体建议。
