Analysis of Factors that affect Recruitment Process and Effectiveness of Recruitment Methods in Treatment Resistant Depression Study

Introduction: The following Research Project is a Process Improvement Study to identify the factors affecting the recruitment process and identify best recruitment method in Treatment Resistant Depression Study. Adequate recruitment is essential to any study's success. Most studies report only the effectiveness of recruitment method, but very few report the cost of randomizations. This research project will analyze the effect of different recruitment methods in the Treatment Resistant Depression Study. The study will work on cost analysis which can be critical when deciding which recruitment methods to implement in Randomized Controlled Clinical Trials. Methods: For this research project, a study will be conducted to analyze the factors that affect the recruitment process and compare the effectiveness of different recruitment methods. Factors include demographical data such as age, gender, ethnicity, race and distance from site. Data for this study will be collected from a randomized double blind, active controlled "Treatment Resistant Depression Study" conducted at North Texas Clinical Trials, Fort Worth, TX. Data will include how many subjects were consented, how many of them were enrolled and how many of them failed the screening process. Results: All four recruitment methods were compared, based on the number of subjects referred, enrolled and randomized for the study. Statistical analysis showed that there was no significant difference between subjects referred, enrolled and randomized using all four methods (p-value: 0.1920). Analysis was performed on data which showed a statistically significant difference between the number of subjects referred and randomized through subject database and clinical connection (p-value: 0.0184). Total pooled data revealed race and distance from site being the only predicting factors on the outcome of being screened into the study. II Conclusion: Patient recruitment is a vital component in assuring the success of a clinical trial and can be time consuming. One method of recruitment alone is not sufficient to meet the target enrollment. It was difficult to prove significant effect of all the factors on the recruitment process due to small sample size, but future studies with larger sample size could potentially reveal more significant impact of factors associated with the recruitment process.