The Persistent Exclusion of Older Patients From Ongoing Clinical Trials Regarding Heart Failure
The Persistent Exclusion of Older Patients From Ongoing Clinical Trials Regarding Heart Failure
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DOI：
10.1001/archinternmed.2011.31
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发表时间：
2011-03-28
影响因子：
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通讯作者：
Mills, Gary H.
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文献类型：
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作者：
Cherubini, Antonio;Oristrell, Joaquim;Mills, Gary H.
背景：许多与老年患者相关的临床研究检查的个体比那些有问题的疾病年轻。心脏衰竭就是一个很好的例子。因此，我们调查了正在进行的有关心力衰竭的临床试验中老年人被排除在外的程度。方法：在增加老年人参与临床试验（PREDICT）研究的背景下，2008年12月1日从世界卫生组织临床试验注册平台提取了正在进行的有关心力衰竭的临床试验数据。主要结果测量指标是通过任意年龄上限或其他可能间接导致老年人招募有限的排除标准排除患者的试验比例。我们将排除标准分为两类：合理或不合理。结果：在251项研究心力衰竭治疗方法的试验中，64项（25.5%）通过任意年龄上限排除了患者。这种排除在欧盟进行的试验中明显比在美国更常见（31/96 [32.3%]vs 17/105 [16.2%]; P = .007），在公共机构资助的药物试验中比在私营实体资助的药物试验中更常见（21/59 [35.6%]vs 5/36 [13.9%]; P = .02）。总体而言，109项心力衰竭试验（43.4%）有1项或更多不合理的排除标准，这可能限制了老年人的纳入。在药理学和非药理学试验中也发现了类似比例的排除标准不合理的临床试验。结论：尽管有国家和国际监管机构的建议，将老年人排除在正在进行的心力衰竭试验之外的情况仍然很普遍。
Background: Much clinical research of relevance to elderly patients examines individuals who are younger than those who have the disease in question. A good example is heart failure. Therefore, we investigated the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure.Methods: In the context of the Increasing the PaRticipation of the ElDerly in Clinical Trials (PREDICT) study, data from ongoing clinical trials regarding heart failure were extracted from the World Health Organization Clinical Trials Registry Platform on December 1, 2008. Main outcome measures were the proportion of trials excluding patients by an arbitrary upper age limit or by other exclusion criteria that might indirectly cause limited recruitment of older individuals. We classified exclusion criteria into 2 categories: justified or poorly justified.Results: Among 251 trials investigating treatments for heart failure, 64 (25.5%) excluded patients by an arbitrary upper age limit. Such exclusion was significantly more common in trials conducted in the European Union than in the United States (31/96 [32.3%] vs 17/105 [16.2%]; P = .007) and in drug trials sponsored by public institutions vs those by private entities (21/59 [35.6%] vs 5/36 [13.9%]; P = .02). Overall, 109 trials (43.4%) on heart failure had 1 or more poorly justified exclusion criteria that could limit the inclusion of older individuals. A similar proportion of clinical trials with poorly justified exclusion criteria was found in pharmacologic and nonpharmacologic trials.Conclusion: Despite the recommendations of national and international regulatory agencies, exclusion of older individuals from ongoing trials regarding heart failure continues to be widespread.