Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study.

Our results, while not generalizable in isolation, provide a valuable starting point to understand the complex construct of subject burden. This preliminary work is intended to be a catalyst for more in-depth research to better understand and predict burden and acceptable burden thresholds in clinical trials. Understanding subject burden is a vital component of human subject research that will be valuable in helping to inform future clinical trial designs.