Seeking Predictable Subject Characteristics That Influence Clinical Trial Discontinuation

Abstract

Subject retention is one of the key factors that determine success of a clinical trial. Many researchers have focused on the issue of recruitment, and few have focused on retention. Subjects discontinue from clinical trials for variety of reasons. Sociodemographic characteristics such as age, gender, race, employment, and level of education have been implicated as the most common influencers for participation in clinical trials. This study evaluated the influence of these sociodemographic characteristics on the risk of subject discontinuation. There was little apparent difference in the sociodemographic characteristics among completers and discontinued subjects. Importantly, it was noticed that there is no common format for reporting clinical trial sociodemographic characteristics, thus leading to difficulties in the interpretation of the influence of such factors on subject retention. Suggestions are provided for future researchers that would greatly enhance the prediction of sociodemographic influences on subject discontinuation. Strategies to overcome such influences may be required.