Factors Affecting Outcomes of Craniofacial Clinical Trials

PURPOSE This study aims to provide a cross-sectional view of craniofacial trials and to identify factors associated with completion, publication, and trial longevity. MATERIALS AND METHODS This is a cross-sectional study of cleft and craniofacial clinical trials registered with ClinicalTrials.gov between September 1999 and April 2020. Predictor variables included funding source, trial design, trial location, number of recruitment sites, and investigator specialty.Study outcomes were completion status, publication status, and trial duration. Univariate comparisons and multivariate regression models were calculated for each outcome. RESULTS The final sample included 179 clinical trials pertaining to craniofacial care. Nearly all trials were single-center (86.5%), and roughly half of trials were interventional (57.0%) or conducted in the United States (40.5%). No single specialty predominated, although plastic surgery (13.4%) was the most common investigator specialty. The completion rate was 82.7%, the publication rate was 40.8%, and the mean trial duration was 39.1 months. Interventional design (odds ratio = 0.30, P = 0.02) and United States location (odds ratio = 0.15, P < 0.01) were each independently associated with lower odds of trial completion. Trial longevity was independently associated with the National Institute of Health-funding (P < 0.01) and multicenter design (P < 0.01). CONCLUSIONS Craniofacial trials are multidisciplinary and have a high rate of completion. Although most existing trials were conducted at only a single-center, multicenter efforts significantly increased trial longevity without compromising completion and publication rates. Given the diverse array of conditions and lines of inquiry that compose craniofacial care, it is reassuring that collaboration did not negatively affect trial outcomes.