Commissie Mensgebonden Onderzoek, Research Ethics Committee, PO Box 9101, Internal Code 578, 6500 HB, Nijmegen, The Netherlands.
J Med Ethics. 2012 Jul;38(7):413-6. doi: 10.1136/medethics-2011-100020. Epub 2012 Feb 28.
Medical research involving human subjects can be risky and burdensome. Therefore, such research must be reviewed and approved by a Research Ethics Committee (REC). To guarantee the safety of the subjects, it is very important that these studies be conducted in accordance with the approved protocol. An important issue in this respect is whether studies include the requisite number of subjects based on the research question. The research question is unlikely to be answered reliably if the requisite number of subjects is not met. In such cases, subjects are exposed to unnecessary risks and burdens. In this descriptive study, the authors evaluated how frequently studies are completed with the required number of subjects. Moreover, the authors identified the characteristics of research that does and does not include the required number of subjects. The results of this study show that a considerable proportion of studies (41/107) were terminated although they failed to recruit a sufficient number of subjects. Furthermore, the authors found that investigator-initiated studies have significantly (p=0.028) more problems in recruiting the requisite number of subjects than studies initiated by pharmaceutical companies. Potential solutions are discussed to reduce the number of studies that do not include a sufficient number of subjects.
医学研究涉及人类受试者可能存在风险和负担。因此，此类研究必须经过研究伦理委员会 (Research Ethics Committee, REC) 的审查和批准。为了保障受试者的安全，按照批准的方案进行这些研究非常重要。在这方面，一个重要的问题是研究是否根据研究问题包含了必要数量的受试者。如果没有达到必要的受试者数量，研究问题就不可能得到可靠的回答。在这种情况下，受试者会面临不必要的风险和负担。在这项描述性研究中，作者评估了研究完成所需数量受试者的频率。此外，作者还确定了包含和不包含必要数量受试者的研究的特征。本研究结果表明，尽管未能招募到足够数量的受试者，但相当一部分研究（41/107）已经终止。此外，作者发现，与由制药公司发起的研究相比，由研究者发起的研究在招募所需数量的受试者方面存在更多问题（p=0.028）。讨论了潜在的解决方案，以减少不包含足够数量受试者的研究数量。
