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EMA发布指南草案,控制临床试验假阳性

阅读: 2017年04月10日

EMA发布指南草案,控制临床试验假阳性


欧洲药品管理局(EMA)发布有关临床试验中多重性问题的指南草案。该指南谈到,当临床试验包含多个治疗组和指标时,该如何减少假阳性的风险。


EMA的指南适用于大多数临床试验。一旦研究设计不再只包含2个治疗组、使用预先定义的虚无假设(Null Hypothsis)和单个主要变量(Primary Variable),又或者增加了期中分析时,申办方均需控制假阳性的发生。EMA在指南中举了1个5个亚组单独分析的试验例子。在一项研究中,如果每个亚组均在2.5%显著性水平,那么发现假阳性统计学意义的检验的概率增至12%。由于生物科技企业为了成功承受着压力,那么风险就出现了,他们有可能利用这些异常作为药物有效的证据。


为了确保试验设计降低此类风险的发生,EMA发布了长达15页的指南。该草案提及的内容包括:需要调整多重性的情况;何时能够从亚组分析中得出可靠的结论;当达到次要指标,次要指标何时才可能成为其他论断的依据;以及如何处理复合指标。


精通临床试验设计的研究人员应该对EMA的许多建议都很熟悉。指南中传达的广泛信息包括:申办方需要预先规定其计划用于论断产品安全性和有效性的任何亚组,以及只有在达到了临床试验的主要指标后,次要指标的显著性作用才可考虑用于其他论断。 


EMA在更早的文件中也多次论及这些话题。EMA首先在2002年发布的“考虑要点”中建立其在临床试验中多重性问题的立场,10年后又发布了概念文件。本周发布的草案征求意见稿以这两个文件为基础,扩展其己涵盖的话题,并纳入对进展的考虑,因为距离第一份文件的发布已有15年头。


新增内容包括有关估计的多重性问题。这部分内容讲到,当试验的复杂性使得临床说明无可借鉴性时该如何处理。在这一部分,EMA对选择偏倚和置信区间进行了讨论。


英语原文    


EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials


The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The text deals with how to mitigate the risk of false positives arising when clinical trials look at multiple treatment groups and endpoints. 


EMA’s guideline is applicable to most clinical trials. Once a study design expands beyond having two treatment groups, one predefined null hypothesis and a single primary variable — or adds an interim analysis — its sponsor needs to control for false positives. EMA cites the example of a trial that analyzes five subgroups independently. If each subgroup has a significance level of 2.5%, the likelihood of the study finding a statistically significant false positive hits 12%. As biotechs are under pressure to succeed, there is a risk they will seize on anomalies as evidence a drug works. 


To ensure trial designs diminish the risk of this happening, EMA has released a 15-page guideline. The draft runs through the situations in which it is necessary to adjust for multiplicity, when it is possible to draw reliable conclusions from subgroup analyses, when success against secondary endpoints can form the basis for additional claims and how to handle composite endpoints.


Researchers well versed in designing clinical trials will be familiar with many of the agency’s recommendations. Broad messages conveyed in the guidelines include the need for sponsors to pre-specify any subgroups they plan to use to assert the safety and efficacy of a product, and the need for a study to hit its primary endpoint if success in secondary objectives is to support a regulatory claim.  


The agency covered many of these topics in earlier documents. EMA first established a position on multiplicity in clinical trials through a “points to consider” text in 2002, before going on to release a concept paper a decade later. The draft guideline released for consultation this week builds on both those texts, both by expanding on the topics they covered and incorporating advances in understanding since the first document was released 15 years ago. 


New additions include a section on multiplicity issues in estimation. This section deals with what to do when the complexity of procedures makes informative clinical interpretation difficult. EMA addresses selection bias and confidence intervals in the section. 





内容来自: RAPS

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