Depp Colin, Lebowitz Barry D
Sam and Rose Stein Institute for Research on Aging, University of California, San Diego, California 92161, USA.
Int Rev Psychiatry. 2007 Oct;19(5):531-9. doi: 10.1080/09540260701563320.
The need for clinical psychiatry research to provide practical information to clinicians, families, and consumers has led to the development of new approaches to clinical trials. Efficacy trials, the historical backbone of clinical research, have many shortcomings in delivering practical information to stakeholders. The 'effectiveness' or 'public-health' model of intervention research targets a diverse group of patients across multiple settings that are outside of academic medical centres, with study design and outcomes that are selected on the basis of their potential to produce clinically meaningful information. The National Institute of Mental Health has funded three such clinical trials in recent years, respectively targeting schizophrenia and Alzheimer's disease, depression, and bipolar disorder. Each of these studies has made a major impact, and provided new insights into the challenges of public health orientated trials in psychiatry. In this review, we describe the underlying principles and practical considerations in efficacy and effectiveness-orientated trials.
临床精神病学研究需要为临床医生、患者家属和消费者提供实用信息，这促使了临床试验新方法的发展。疗效试验作为临床研究的历史支柱，在向利益相关者提供实用信息方面存在许多不足。干预研究的“有效性”或“公共卫生”模式针对学术医学中心以外多种环境中的不同患者群体，其研究设计和结果是根据产生具有临床意义信息的潜力来选择的。美国国立精神卫生研究所近年来资助了三项此类临床试验，分别针对精神分裂症和阿尔茨海默病、抑郁症以及双相情感障碍。这些研究中的每一项都产生了重大影响，并为精神病学中以公共卫生为导向的试验所面临的挑战提供了新的见解。在本综述中，我们描述了以疗效和有效性为导向的试验的基本原则和实际考量。
