A Comparative Analysis of Recruitment Methods used in Randomized Controlled Clinical Drug Trials
Garud, Ashwini A.
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Clinical trials are a crucial part of any drug development process. The reliability and validity of clinical trials depend on the successful recruitment of subjects. The overall goal of this project was to evaluate the effectiveness of subject recruitment methods used in Randomized Controlled Trials (RCTs) focusing on Major Depressive Disorder (MDD) and Postpartum Depression (PPD) studies. Recruitment methods (on-site and off-site) utilized in these trials were examined for their cost-effectiveness, recruitment return, including the number of subjects enrolled and the number of subjects randomized in the trial and subject demographics. Regarding cost effectiveness, on-site methods were found to be more effective in terms of recruitment return and less costly than off-site for both studies. There was a significant difference in race and gender when subjects were recruited from on-site versus off-site recruitment. For MDD study, a comparatively large number of enrolled and randomized participants were recruited from on-site recruitment methods as compared to off-site, this may be due to the number of physician referrals, indicating that physicians play a major role in subject recruitment. For the Postpartum Depression study, the number of enrolled and randomized subjects from off-site recruitment method was higher than those of on-site methods. Monitoring recruitment strategies implemented in the study and assessing their effectiveness would be helpful in employing strategies for future trials.