Representativeness of patients enrolled in infl uential clinical trials: A comparison of substance dependence with other medical disorders

Abstract

Objective: The purpose of this study was to determine whether randomized trials of treatments for substance dependence differ from those for other medical disorders on quality of enrollment information reporting and sample representativeness. Method: Twenty highly cited clinical trials (publication date 2002-2010) of treatments for each of 14 prevalent disorders were identifi ed by structured literature search. The disorders were alcohol dependence, drug dependence, nicotine dependence, Alzheimer's disease, breast cancer, colorectal cancer, chronic obstructive pulmonary disease, depression, diabetes, HIV/AIDS, hypertension, ischemic heart disease, lung cancer, and schizophrenia. The 280 clinical trials were coded for number of individuals screened for eligibility, number of screened individuals meeting eligibility criteria, and number of eligible individuals refusing to participate. Results: Substance-dependence treatment trials were signifi cantly more likely to track and report enrollment information (75% vs. 45% of clinical trials for other disorders, p