Unlocking the Keys to Site Activation and Recruitment Success in a Randomized Controlled Trial

See related article, p 2511 While randomized controlled trials (RCTs) remain the gold standard investigation for determining the effectiveness of various medications or therapeutic approaches to the more optimal management of patients with infectious or noncommunicable diseases, RCTs can be incredibly complex to design and difficult to conduct. By extension, these trials can be extremely costly to recruit and successfully follow adequate numbers of patients to the trial, as well as include representative patient populations for purposes of more broadly generalizing the eventual trial findings. Two of the most crucial requirements for successfully carrying out and completing an RCT are the initial construction of different hypothetical scenarios to determine how many healthy individuals or patients with a specific disease or condition are needed to be enrolled in the trial and eventually followed on either a short- or long-term basis to find clinically meaningful differences in one’s principal study outcomes and, subsequently, to go out into the field, find, and recruit a sufficient number of patients to the proposed trial to satisfy one’s predetermined sample size requirements. Moreover, the logistical operations of an RCT need to be performed within the confines of a manageable budget and typically tight timeline for patient enrollment and follow-up in which all too often projected estimates of the number of patients to be enrolled and successfully retained in the trial greatly exceed reality. In their interesting, relatively novel, and useful article, Demaerschalk et al1 present data on the selection process involved in recruiting a large number of study sites to the multicenter CREST-2 trial (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trials). Despite the large volume of RCTs conducted annually in the United States and elsewhere, surprisingly little data exist describing the site selection process involved in multicenter RCTs and factors associated with …