Exploring Differences in Screening and Enrollment Metrics in Orthopaedic Clinical Trials

Abstract

Background: The success of any clinical trial relies heavily on patient recruitment and retention. The purpose of this study was to review screening and enrollment metrics for orthopaedic clinical trials, comparing different patient populations to determine common challenges to recruitment and differences in rates of enrollment. Methods: Screening logs and study trackers were manually reviewed for 4 clinical trials at a single, academic institution and included RCTs and an observational study. Data extracted from these documents included the number of patients screened, number excluded and reasons for exclusion, number enrolled, number of withdrawn and reason. Results: Of the 4 trials reviewed, the POC diagnostic test had the highest number of patients excluded and the lowest patient refusal rate. Refusal rates were highest in the VTE prophylaxis study and enrollment rates were the lowest in the RCT of drug treatments and the highest rate in the observational study. Conclusion: The success of the trial relies on the ability to recruit patients and factors need to be considered when recruiting participants including sample size requirements and inclusion and exclusion criteria. These data provide some insights into the patient recruitment experience at our institution with different patient populations and study types, highlighting key points to be aware of when planning for an orthopaedic clinical trial. Keywords: enrollment, recruitment, RCT, outcomes, primary, revision