Minimizing Patient Burden in Clinical Trials
Understanding the perceived burden of clinical trial participation is essential for patient-centric trial design. This preliminary study provides valuable insights into how patients experience the burden of completing Patient-Reported Outcome (PRO) measures, revealing important patterns that can help researchers design more patient-friendly protocols.
The research reveals clear preferences: participants found evening completion less burdensome than morning completion, weekly completion less burdensome than daily, and twice-daily completion more burdensome than once-daily. While not generalizable in isolation, these findings offer a starting point for understanding the complex construct of subject burden and establishing acceptable thresholds in clinical trials.
This knowledge is vital for designing protocols that minimize participant burden while maintaining data integrity - ultimately supporting better recruitment, retention, and data quality in your clinical trials.
This article was originally published in Therapeutic Innovation & Regulatory Science by Bodart et al. (2018) on behalf of the ePRO Consortium. The views expressed are those of the authors.
