Hey Spencer Phillips, Weijer Charles
Biomedical Ethics Unit, McGill University, Montreal, QC H3A 1X1, Canada.
Perspect Biol Med. 2013 Winter;56(1):1-17. doi: 10.1353/pbm.2013.0002.
This article examines the concept of assay sensitivity in clinical research. Defined as the ability of a clinical trial to distinguish between an effective and ineffective treatment, the need for assay sensitivity has been taken to support the claim that placebos are methodologically superior to active control treatments. The demands of doing good clinical science must trump the physician-researcher's ethical duty to provide all trial participants with nothing less than competent medical care. We argue that this supposed implication of assay sensitivity rests on (1) collapsing the distinction between biological efficacy and clinical effectiveness, and (2) conflating the epistemic contexts of a trial-as-designed and a trial-as-executed. Once these errors are corrected, it becomes clear that placebos grant no epistemological advantage over active controls, and there is therefore no longer a tension between the epistemic and ethical demands of research. We suggest that the legitimate worries behind assay sensitivity can be better understood as the need for researchers to articulate their experimental heuristics and to demonstrate a robust pattern of evidence across a series of trials.
本文探讨了临床研究中检测灵敏度的概念。检测灵敏度被定义为临床试验区分有效治疗与无效治疗的能力，对检测灵敏度的需求被用来支持安慰剂在方法学上优于活性对照治疗的观点。做好临床科学的要求必须优先于医师-研究人员的道德责任，即要为所有试验参与者提供至少合格的医疗护理。我们认为，检测灵敏度的这种所谓含义基于：（1）混淆生物学效力和临床有效性之间的区别，以及（2）将设计中的试验和实施中的试验的认知背景混为一谈。一旦纠正这些错误，就会清楚地看到，安慰剂相对于活性对照没有认知优势，因此研究的认知需求和道德需求之间也就不再存在紧张关系。我们建议，检测灵敏度背后合理的担忧可以更好地理解为研究人员需要阐明他们的实验启发法，并在一系列试验中展示强有力的证据模式。
