Abstract
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. Screening logs and study trackers
were manually reviewed for four clinical trials at a single academic institution and
included randomized controlled trials (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reasons for exclusion, number enrolled, number of withdrawn and reason. Of the four
trials reviewed, the point-of-care diagnostic test had the highest number of patients
excluded and the lowest patient refusal rate. Refusal rates were highest in the venous
thromboembolism prophylaxis study and enrollment rates were the lowest in the RCT
of drug treatments and the highest rate in the observational study. 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 - primary - revision
