Extent and Reporting of Patient Nonenrollment in Influential Randomized Clinical Trials, 2002 to 2010

Abstract

Because they assign patients to treatment conditions, randomized clinical trials (RCTs) offer unparalleled internal validity for drawing inferences about the efficacy of a medical treatment.2][3][4][5][6] The challenges of judging the clinical utility of clinical trial results are increased by poor reporting: Gross and colleagues' study of trials published in leading medical journals from 1999-2000 found that only 28% reported the proportion of screened patients who were enrolled. 7These deficiencies may have been ameliorated in the past decade because the CONSORT statement was revised in 2001 to require more complete information on the enrollment process in reports of clinical trials 8 , and because many treatment research fields have been showing greater concern about generating knowledge that better informs clinical practice.Accordingly, the present study assessed the extent to which low enrollment rates are still characteristic of widely-cited clinical trials, and whether reporting of enrollment information has improved. MethodsA Web of Science search was employed to identify the 20 most influential English-language RCTs for each of 14 prevalent chronic disorders (alcohol dependence, Alzheimer's, breast cancer, colorectal cancer, COPD, depression, diabetes, drug dependence, HIV/AIDS, hypertension, ischemic heart disease, lung cancer, nicotine dependence and schizophrenia) published from 2002-2010 (see supplementary material for search terms and citations returned).We sorted the results on citations per year rather than total citations so that recently published trials would still have the chance to rank as influential.Top-cited articles that were not RCTs (e.g., major literature reviews) were excluded.The final dataset comprised 280 studies (20 studies for each of 14 conditions).Raters double-coded the studies on the number of patients with the disorder of interest who were screened for trial eligibility, the number who were eligible, and the number of eligible None of the authors has any conflicts of interest to disclose.The authorial team gathered and analyzed the data for this study themselves.Dr. Humphreys had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

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