Dal-Ré R, Morell F, Tejedor J C, Gracia D
Investigación Clínica, Programa BUC (Biociencias UAM+CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, España.
Servicio de Neumología, Hospital Universitario Valld'Hebrón, Barcelona, España.
Rev Clin Esp (Barc). 2014 Nov;214(8):470-4. doi: 10.1016/j.rce.2014.03.013. Epub 2014 May 14.
A clinical trial seeks information for the benefit of future patients and not necessarily for those who participate in the study. However, there are patients who believe that they will receive a direct therapeutic benefit by participating in a clinical trial, the so-called «therapeutic misconception». In this article, we describe the nature and extent of therapeutic misconception, which researchers can also experience. Its presence is especially important in phase 1 oncology trials and those with placebo group. To limit its occurrence, investigators have to ensure that participant information sheet are well written and to establish an effective and transparent discussion during the process of obtaining informed consent so that patients understand all aspects of their participation in the research and appreciate what this participation entails.
一项临床试验旨在获取信息以造福未来的患者，而不一定是为了参与研究的患者。然而，有些患者认为他们通过参与临床试验将直接获得治疗益处，即所谓的“治疗误解”。在本文中，我们描述了治疗误解的性质和程度，研究人员也可能会有这种误解。它的存在在肿瘤学1期试验和有安慰剂组的试验中尤为重要。为了限制其发生，研究人员必须确保参与者信息表撰写得当，并在获得知情同意的过程中进行有效且透明的讨论，以便患者了解其参与研究的各个方面，并明白这种参与意味着什么。
