Reasons for patient′s withdrawal from clinical trials of rheumatoid arthritis in India

Abstract

Introduction: Rheumatoid arthritis (RA) affects 0.5-1% of population all over the world. As the duration of treatment is more in RA, patient′s adherence to treatment is less. Controlling the number of patients lost to follow-up is essential for the successful completion of randomized clinical trials. Also, patient adherence is critical in clinical trial setting as it has impact on validity of clinical data and also it remains an issue of utmost importance to pharmaceutical manufacturers as well as scientific and regulatory community. The studies which show reasons for withdrawal from clinical trials are done for diseases like tuberculosis (TB). None of the study is available to find reasons for withdrawal from clinical trials in RA. Hence, this study is planned. Aims and Objectives: Find reasons and effect of age, sex, duration of therapy, and distance from home on withdrawal from clinical trial. Materials and Methods: This study is a retrospective observational data analysis. Primary outcome are to find reasons for withdrawal from trial. Results: Withdrawal from clinical trial in patients of RA is more in female. In this study, reasons for withdrawal from study are change in location, loss to follow-up, failure of therapy, concomitant illness, patient withdrew consent, and adverse effects is the common reason for withdrawal from clinical trial in both patient and investigator-related reason for withdrawal.