Title

Patient Retention in Clinical Trials

Date of Award

12-1-2013

Degree Type

Thesis

Degree Name

Master of Science

Department

Graduate School of Biomedical Sciences

First Advisor

Patricia Gwirtz

Abstract

The main objective of this practicum project is to analyze and demonstrate the importance of retention of subjects enrolled in a clinical trial study. The goal of this research project is to analyze the retention process in clinical trials, by discussing in detail many aspects pertaining to the subject active participation and retention until the completion of the study. This project summarizes the importance of retention of research subjects after they sign the informed consent form, barriers and challenges associated with subject retention in clinical trials and the novel strategies followed to overcome these barriers.

The subjects are actively engaged with the study until the end through the active implementation of strategies recommended by FDA. Subjects of the study were contacted by mail and phone calls and they were reminded about their follow up visit schedules at regular intervals. As a part of this project, certified letters were sent to the subjects acknowledging their active participation and thanking them for their continuous support with the study. Later on, the subjects were contacted over the phone and the visit was scheduled within the time frame of the study protocol. Care was taken that everything is done in accordance with the protocol of the study and to ensure that the follow up visit was scheduled at convenient time for the subjects. Finally, the number of subjects in the experimental group who successfully completed the follow up visit during the practicum period was counted and the retention rate determined and compared to that of control group.

Comments

Available December 2016.

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