Recruitment, Retention and Compliance in Randomized, Phase III Clinical Trials Involving Obese Patients Diagnosed with Type 2 Diabetes Mellitus with Respect to Weight Loss.




Mithani, Moez S.


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Human research and clinical trials face many obstacles that prevent or hinder efficient and reliable data and results from being collected, analyzed, and reported. This is especially true in clinical trials involving type 2 diabetes. The purpose of this study is to understand issues relating to the recruitment, retention, and compliance of Type 2 diabetic subjects in phase III clinical trials. The data used in this study was collected from a parent study already conducted at the investigator site. The results indicate that issues with recruitment are attributed primarily to the inclusion/exclusion criteria, especially HbA1c values and changes in medication usage. Decreases in retention were primarily due to a lack of involvement in the control group on part of the subject and the coordinator and also due to a lack of significant results in a timely manner. Issues with compliance were found to be due to a lack of discipline on the part of the subject to make lifestyle adjustments and a lack of time in the daily schedule to add an exercise program and employ healthy dieting regimen.