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

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] These 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.