The Future of Clinical Trials in Cardiovascular Medicine
The Future of Clinical Trials in Cardiovascular Medicine
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DOI：
10.1161/circulationaha.115.020723
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发表时间：
2016-06-21
期刊：
影响因子：
37.8
通讯作者：
Pfeffer, Marc A.
中科院分区：
文献类型：
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作者：
Solomon, Scott D.;Pfeffer, Marc A.
所罗门和Pfeffer研究的CV医学临床试验的未来2663和对特定疗法的潜在反应。在过去的四分之一世纪中，心血管试验中使用的终点已经变得更加直接和更能反映潜在的治疗靶点，从使用更多的非特异性终点（如全因死亡率）转变为使用更多的疾病特异性终点。大多数心血管试验目前使用致死性（例如，死亡或心血管死亡）和非致死性终点（例如，心肌梗死、卒中、心力衰竭住院治疗）的组合，通常称为主要心血管不良事件，尽管主要心血管不良事件组分的确切组成具有高度可变性。9从监管的角度来看，关键性试验取决于主要终点的成功，并且基于未达到主要终点的试验而批准的治疗是极其罕见的。
Solomon and Pfeffer Future of Clinical Trials in CV Medicine 2663 studied and the potential response to a particular therapy. Over the past quarter century, the end points used in cardiovascular trials have become more directed and more reflective of the potential therapeutic targets, with a shift from using more nonspecific end points, such as all-cause mortality, to more disease-specific end points. Most cardiovascular trials currently use a combination of fatal (eg, death or cardiovascular death) and nonfatal end points (eg, myocardial infarction, stroke, heart failure hospitalization) in a composite often termed major adverse cardiovascular events, although the exact makeup of the components of major adverse cardiovascular events has been highly variable. 9 From a regulatory perspective, pivotal trials are dependent on the success of the primary end point, and it is extremely rare for a therapy to be approved based on a trial in which the primary end point was not met.