Feifel David
Dr. Feifel is Professor, Department of Psychiatry; Director, Neuropsychiatry and Behavioral Medicine Program; Director, UCSD Adult ADHD Program, University of California, San Diego Medical Center, San Diego, California.
Psychiatry (Edgmont). 2009 Dec;6(12):19-25.
This is Part 2 of a two-part series on the ethical issues surrounding the use of placebo arms in clinical trials for psychiatric drugs. Part 1 discussed the ethical argument from a statistical, population-based perspective. Part 2 explores the ethical issues of placebo-controlled studies as they relate to individual psychiatric patients who may participate in them. Many patients who are candidates for psychiatric clinical trials would receive poor treatment for their mental illness under standard treatment conditions. Industry-sponsored clinical trials often provide treatment resources otherwise not available to patients at a more intense level of care than the local standard. Moreover, study design features, such as those developed at University of California, San Diego (presented herein), can mitigate the risks of placebo arms. With this in mind, clinical trials represent an ethical option for many patients with chronic mental illness.
这是关于精神科药物临床试验中使用安慰剂组所涉及伦理问题的系列文章的第二部分。第一部分从基于统计学和人群的角度讨论了伦理观点。第二部分探讨了安慰剂对照研究与可能参与其中的个体精神科患者相关的伦理问题。许多有资格参加精神科临床试验的患者在标准治疗条件下，其精神疾病可能得不到良好治疗。行业资助的临床试验通常会提供比当地标准更强化护理水平的治疗资源，而这些资源患者在其他情况下无法获得。此外，研究设计特点，比如加利福尼亚大学圣地亚哥分校所开发的那些特点（本文有介绍），可以减轻安慰剂组的风险。考虑到这一点，临床试验对许多患有慢性精神疾病的患者来说是一种符合伦理的选择。
