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Hollow Hunt for Harms

机译：空心猎杀

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Harms of medical interventions are systematically underestimated in clinical research. Numerous factors—conceptual, methodological, and social—contribute to this underestimation. I articulate the depth of such underestimation by describing these factors at the various stages of clinical research. Before any evidence is gathered, the ways harms are operationalized in clinical research contributes to their underestimation. Medical interventions are first tested in phase 1 “first in human” trials, but evidence from these trials is rarely published, despite the fact that such trials provide the foundation for assessing the harm profile of medical interventions. If a medical intervention is deemed safe in a phase 1 trial, it is tested in larger phase 2 and 3 clinical trials. One way to think about the problem of underestimating harms is in terms of the statistical power of a clinical trial—the ability of a trial to detect a difference of a certain effect size between the experimental group and the control group. Power is normally thought to be pertinent to detecting benefits of medical interventions. It is important, though, to distinguish between the ability of a trial to detect benefits and the ability of a trial to detect harms. I refer to the former as powerB and the latter as powerH. I identify several factors that maximize powerB by sacrificing powerH in phase 3 clinical trials. If a medical intervention is approved for general use, it is evaluated by phase 4 post-market surveillance. Phase 4 surveillance of harms further contributes to underestimating the harm profile of medical interventions. At every stage of clinical research the hunt for harms is shrouded in secrecy, which further contributes to the underestimation of the harm profiles of medical interventions.
机译：在临床研究中，医疗干预的危害被系统地低估了。许多因素（包括概念，方法和社会因素）导致了这种低估。我通过描述临床研究各个阶段中的这些因素来阐明这种低估的深度。在收集任何证据之前，临床研究中如何将危害进行处理会导致危害被低估。医疗干预措施首先在“人类第一项”试验的第一阶段中进行测试，但是尽管这些试验为评估医疗干预措施的危害提供了基础，但很少公开这些试验的证据。如果在第1阶段试验中认为医疗干预是安全的，则将在较大的第2和第3阶段临床试验中进行测试。思考危害低估问题的一种方法是根据临床试验的统计能力，即试验能够检测出实验组和对照组之间特定效应大小的差异的能力。通常认为，权力与检测医疗干预的益处有关。但是，区分审判发现利益的能力和审判发现危害的能力很重要。我将前者称为powerB，将后者称为powerH。我确定了在3期临床试验中通过牺牲powerH来最大化powerB的几个因素。如果医疗干预措施获准用于一般用途，则将通过第4阶段的上市后监督对其进行评估。危害的第四阶段监视进一步导致低估了医疗干预措施的危害状况。在临床研究的每个阶段，对危害的追捕都是保密的，这进一步有助于低估医疗干预措施的危害。

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  • 来源
    《Perspectives on science》 |2016年第5期|481-504|共24页
  • 作者

    Jacob Stegenga;

  • 作者单位

    University of Victoria University of Johannesburg;

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  • 正文语种 eng
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