New York State Psychiatric Institute/Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY 10032, USA.
Drug Alcohol Depend. 2010 Sep 1;111(1-2):177-81. doi: 10.1016/j.drugalcdep.2010.04.009. Epub 2010 May 26.
There is growing concern that results of tightly controlled clinical trials may not generalize to broader community samples. To assess the proportion of community dwelling adults with cannabis dependence who would have been eligible for a typical cannabis dependence treatment study, we applied a standard set of eligibility criteria commonly used in cannabis outcome studies to a large (N=43,093) representative US adult sample interviewed face-to-face, the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). Approximately 80% of the community sample of adults with a diagnosis of cannabis dependence (N=133) would be excluded from participating in clinical trials by one or more of the common eligibility criteria. Individual study criteria excluded from 0% to 41.0% of the community sample. Legal problems, other illicit drug use disorders, and current use of fewer than 5 joints/week excluded the largest percentage of individuals. These results extend to cannabis dependence concerns that typical clinical trials likely exclude most community dwelling adults with the disorder. The results also support the notion that clinical trials tend to recruit highly selective samples, rather than adults who are representative of typical patients. Clinical trials should carefully evaluate the effects of eligibility criteria on the generalizability of their results. Even in efficacy trials, stringent exclusionary criteria could limit the representativeness of study results.
人们越来越担心，严格控制的临床试验结果可能无法推广到更广泛的社区样本。为了评估有大麻依赖的社区居住成年人中有多少比例符合典型大麻依赖治疗研究的条件，我们将一套常用的大麻结果研究的标准纳入标准应用于一个大型的（N=43093）具有代表性的美国成年人面对面访谈样本，即国家酒精和相关条件流行病学调查（NESARC）。大约 80%的有大麻依赖诊断的社区成年人样本（N=133）会因为一个或多个常见的纳入标准而被排除在临床试验之外。个别研究标准将社区样本的 0%至 41.0%排除在外。法律问题、其他非法药物使用障碍和目前每周少于 5 个烟卷的使用排除了最大比例的个体。这些结果扩展到了大麻依赖的担忧，即典型的临床试验可能排除了大多数患有该疾病的社区居住成年人。结果还支持了这样一种观点，即临床试验往往招募高度选择性的样本，而不是代表典型患者的成年人。临床试验应仔细评估纳入标准对其结果普遍性的影响。即使在疗效试验中，严格的排除标准也可能限制研究结果的代表性。
