Institute for History, Philosophy and Ethics of Medicine, University Medical Center Mainz, Am Pulverturm 13, Mainz, Germany.
J Med Ethics. 2012 Jan;38(1):57-9. doi: 10.1136/medethics-2011-100026. Epub 2011 Aug 25.
The current focus on early intervention trials in Alzheimer's disease research raises particular ethical issues. These arise out of problems of validating study results and translating them into general practice for one thing and out of unwanted effects of an uncertain diagnosis for diagnosed people for another. The first addresses the demands of scientific research compared to those of medical practice, questioning how the medical value of clinical trials is evaluated. The second relates the scientific and medical value of early intervention trials to the normative value of an uncertain diagnosis. Are people who are diagnosed with a potential early form of AD in clinical studies patients proper-although they would not have been diagnosed with the given "disease" in non-research-oriented medical settings? The very problem of framing this question in terms of diagnostic misconceptions connects conceptual with ethical issues of research into preclinical stages of neurodegenerative diseases.
目前，阿尔茨海默病研究中的早期干预试验引起了一些特殊的伦理问题。这些问题源于验证研究结果并将其转化为常规实践的问题，以及不确定诊断对被诊断人群产生的不良影响。第一个问题涉及科学研究与医学实践的需求之间的矛盾，质疑如何评估临床试验的医学价值。第二个问题将早期干预试验的科学和医学价值与不确定诊断的规范价值联系起来。在临床研究中被诊断为潜在早期形式的 AD 的人是否是合适的患者——尽管在非以研究为导向的医疗环境中，他们不会被诊断为给定的“疾病”？将这个问题表述为诊断误解的问题本身就将神经退行性疾病临床前阶段的研究中的概念问题与伦理问题联系起来了。
