Centre for Research Ethics & Bioethics, Uppsala University, Uppsala, Sweden,
Support Care Cancer. 2013 Nov;21(11):3137-42. doi: 10.1007/s00520-013-1891-7. Epub 2013 Jul 18.
In cancer, phase 1 clinical trials on new drugs mostly involve patients with advanced disease that is unresponsive to standard therapy. The purpose of this study was to explore the difficult ethical problems related to patient information and motives for participation in such trials.
A descriptive and explorative qualitative design was used. Fourteen cancer patients from three different phase 1 trials in end-stage cancer were interviewed. The interviews were analysed using qualitative content analysis.
The patients expressed unrealistic expectations of therapeutic benefit and inadequate understanding of the trials' purpose, so-called therapeutic misconception. However, they reported a positive attitude towards participation. Thus, the patients valued the close and unique medical and psychological attention they received by participating. Participation also made them feel unique and notable.
Patients with end-stage cancer participating in phase 1 clinical trials are unaware of the very small potential for treatment benefit and the risk of harm. Trial participation may offer hope and social-emotional support and a strategy for coping with the emotional stress associated with advanced cancer and may, consequently, improve emotional well-being.
在癌症中，新药的 1 期临床试验主要涉及对标准疗法无反应的晚期疾病患者。本研究旨在探讨与患者信息和参与此类试验的动机相关的困难伦理问题。
采用描述性和探索性定性设计。对来自三种不同晚期癌症 1 期试验的 14 名癌症患者进行了访谈。使用定性内容分析对访谈进行了分析。
患者对治疗益处表现出不切实际的期望和对试验目的的理解不足，即所谓的治疗误解。然而，他们报告了对参与的积极态度。因此，患者重视通过参与获得的密切而独特的医疗和心理关注。参与也使他们感到独特和引人注目。
参加 1 期临床试验的晚期癌症患者不知道治疗获益的潜力很小，而且存在潜在的伤害风险。试验参与可能提供希望和社会情感支持，以及应对晚期癌症相关情绪压力的策略，从而可能改善情绪健康。
