Iyer Alexander A, Hendriks Saskia, Rid Annette
Fellow in the Department of Bioethics at the National Institutes of Health (NIH) Clinical Center.
Bioethicist in the Department of Bioethics at the National Institutes of Health Clinical Center.
Ethics Hum Res. 2020 Jul;42(4):35-40. doi: 10.1002/eahr.500061. Epub 2020 Jun 22.
As hospitals have experienced a surge of Covid-19 patients, investigators of Covid-19 treatment trials face a difficult problem: when an institution has more eligible and interested patients than trial slots, who should be enrolled? Defining a clear strategy for selecting participants for "high-demand" Covid-19 treatment trials is important to avoid ad hoc and potentially biased decision-making by local investigators, which could inadvertently compromise a trial's social value, participants' interests, or fairness. In this article, we propose a set of ethical criteria for evaluating participant-selection strategies for such trials. We argue that the pandemic context-in particular, great urgency to develop safe and effective treatments, uncertainty surrounding Covid-19, and strain on the health care system that limits the time and effort available for trial enrollment-favors participant-selection strategies that optimize the ease of enrollment and, ideally, social value. A lottery and, where possible, a weighted lottery have important advantages in these respects.
随着医院收治的新冠患者激增，新冠治疗试验的研究者面临一个难题：当一个机构中符合条件且有意愿参与试验的患者数量超过试验名额时，应该招募谁？为“高需求”的新冠治疗试验制定明确的参与者选择策略，对于避免当地研究者进行临时且可能有偏差的决策非常重要，因为这种决策可能会无意中损害试验的社会价值、参与者的利益或公平性。在本文中，我们提出了一套伦理标准，用于评估此类试验的参与者选择策略。我们认为，疫情背景下——特别是开发安全有效治疗方法的紧迫性、围绕新冠的不确定性以及医疗系统的压力（这限制了用于试验招募的时间和精力）——有利于采用能够优化招募便利性且理想情况下能提升社会价值的参与者选择策略。在这些方面，抽签以及在可能的情况下采用加权抽签具有重要优势。
