Predictors of Research Subject retention - Repetitive non-adherence or socioeconomic factors: Insights from a urological clinical trial

Abstract

Abstract Background: To investigate various patient level variables, specifically socioeconomic status, as risk factors for withdrawal in a recently completed clinical study. We specifically investigate a recent study in men on adherence to an observational prostate cancer imaging and biomarkers study. Methods: We performed a retrospective study to investigate risk factors for withdrawal in a prostate cancer imaging study that enrolled men on active surveillance from January 2016 to June 2019. For each subject, we assessed their retention status and collected demographic data. We compared values between the two retention groups using T-test, Chi-Squared, and logistic regression. Results: Out of 273 men screened, 123 men were enrolled and included in the results of this study. Of those, 106 (86%) were retained in the study and 17 (14%) were withdrawn. While we found no significant relationship between low socioeconomic status and retention, we did find that the number of non-adherences was a significant factor in withdrawal from the study (OR 2.5, 95% CI 3.5–40.5, p < 0.001). Conclusions: Expanding diverse inclusion and limiting withdrawal with real-time non-adherence monitoring will lead to more efficient clinical research and greater generalizability of results.