Keith S J
Department of Psychiatry, School of Medicine, University of New Mexico Health Services Center, Albuquerque 87131, USA.
J Clin Psychiatry. 2001;62 Suppl 9:11-4; discussion 15-6.
Patient selection and dropout rates can affect the results of a clinical trial. Long lists of exclusions in the selection of patients for clinical trials reduce the possibility of examining treatment responses for heterogeneity and make recruitment difficult. In many cases, a pool of 100 potential subjects may yield only 2 or 3 qualified participants, a fact that raises the issue of generalizability of results. Dropouts should be carefully defined in advance and can be used as dependent variables for the comparison of different treatments. This article discusses some of the sampling characteristics (gender, age, diagnosis, inpatient/ outpatient status, prior neuroleptic use, and symptom severity) and dropout rates in 5 recent comparative clinical trials of atypical antipsychotics.
患者的选择和脱落率会影响临床试验的结果。在临床试验患者选择过程中列出的大量排除标准降低了研究治疗反应异质性的可能性,并使招募变得困难。在许多情况下,100名潜在受试者中可能只有2或3名符合条件的参与者,这一事实引发了结果普遍性的问题。脱落情况应提前仔细定义,并可作为比较不同治疗方法的因变量。本文讨论了近期5项非典型抗精神病药物比较临床试验中的一些抽样特征(性别、年龄、诊断、住院/门诊状态、先前使用抗精神病药物情况以及症状严重程度)和脱落率。