Fisk John D
Department of Psychiatry, Medicine and Psychology, Dalhousie University, Halifax, Nova Scotia, Canada.
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S32-6. doi: 10.1017/s0317167100005539.
Clinical trials in persons with dementia bring into focus the ethical dilemmas frequently confronting the clinician-scientist. Despite the existence of various ethical guidelines, most with common underlying principles, few are specific to dementia. A particular difficulty is finding a balance between respect for the autonomy of the individual and the protection of vulnerable persons, while at the same time defining an acceptable risk/benefit ratio for the study. The availability of symptomatic treatments for Alzheimer's disease also now make it difficult to argue that withholding treatment from those in the placebo arm of a clinical trial fulfills one's duty to provide best care. Those conducting clinical trials must be knowledgeable about existing legislation and ethical guidelines in order to justify to themselves and others, the design of clinical trials and their risks. They must be prepared to educate patients and family members about dementia and research, determine each potential subject's competence to consent, and ensure that decisions about participation are in accordance with the best interests of the subject. Ethical conduct of clinical trials of new antidementia therapies will require that everyone involved understands the values and beliefs that guide their decision-making and the potentially conflicting roles facing the clinician-scientist.
针对痴呆症患者的临床试验使临床医生兼科学家经常面临的伦理困境成为焦点。尽管存在各种伦理准则，其中大多数都有共同的基本原则，但很少有专门针对痴呆症的。一个特别的难题是在尊重个人自主权和保护弱势群体之间找到平衡，同时为研究确定可接受的风险/收益比。目前，针对阿尔茨海默病的对症治疗手段的出现，也使得很难辩称在临床试验的安慰剂组中不给患者治疗就是履行了提供最佳治疗的职责。进行临床试验的人员必须了解现行法律和伦理准则，以便向自己和他人证明临床试验的设计及其风险是合理的。他们必须准备好向患者及其家属宣传痴呆症和研究方面的知识，确定每个潜在受试者的同意能力，并确保关于参与试验的决定符合受试者的最大利益。新的抗痴呆疗法临床试验的伦理实施将要求每个相关人员理解指导其决策的价值观和信念，以及临床医生兼科学家所面临的潜在冲突角色。
