Godskesen T M, Kihlbom U, Nordin K, Silén M, Nygren P
Centre for Research Ethics & Bioethics, Uppsala University, Uppsala, Sweden.
Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
Eur J Cancer Care (Engl). 2016 May;25(3):516-23. doi: 10.1111/ecc.12319. Epub 2015 Apr 21.
While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups.
虽然临床肿瘤学试验的参与者对癌症治疗的进展至关重要，但已描述了决定患者参与的因素，但仍需进一步研究，尤其是在3期研究的情况下。本研究的目的是调查在3期临床癌症试验中，参与试验的知识和动机在性别、年龄、教育水平和既往试验经验方面的差异。对96名患者中的88名（92%）返回的问卷结果使用曼-惠特尼U检验进行分析。按性别、年龄或教育程度分层时，患者之间在试验知识方面存在微小的、几乎不相关的差异。有既往试验经验的参与者对退出权的了解较少。男性参与者和65岁及以上的参与者受责任感或亲近之人意见的激励明显更强。男性似乎比女性更受外部因素的激励。鉴于认识到老年男性和单身男性参与者可能是弱势群体，且有既往试验经验的参与者不太可能得到充分告知，信息同意过程应更多地关注这些患者。我们得出结论，知情同意过程似乎运作良好，在大多数亚组中都有良好结果。
