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Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials
Abigail Dirks1, Hana Do2, Chelsea Gallagher3
1Tufts Center for the Study of Drug Development, Boston, United States. abigail.dirks@tufts.edu.
Therapeutic Innovation & Regulatory Science
|August 21, 2025
Summary
Clinical trial participation burden varies by assessment type and duration. Understanding patient and site burden from clinical outcome assessments can inform protocol design to reduce trial complexity.
Area of Science:
- Clinical trial methodology
- Patient-reported outcomes research
- Health services research
Background:
- Bristol Myers Squibb (BMS), ZS, and Tufts CSDD evaluated participation burden in clinical outcome assessments (COAs).
- This evaluation focused on patient-reported outcomes (PROs) and other COAs used in clinical trials.
Purpose of the Study:
- To assess the participation burden associated with various COAs in clinical trials.
- To identify factors contributing to patient and investigative site burden.
- To inform strategies for reducing participation burden in clinical trial design.
Main Methods:
- A mixed-methods approach was employed.
- An online global survey of 258 patients was conducted.
- In-depth interviews were held with 12 patients and 12 investigative site personnel.
Main Results:
- Patient perception of burden differed significantly based on COA modality and type.
- COAs exceeding 30 minutes or administered multiple times monthly were associated with higher burden.
- Patient age, ethnicity, and technical challenges with electronic COAs impacted perceived burden.
Conclusions:
- Study findings increase awareness of patient participation burden related to COAs.
- Results inform decisions to selectively reduce participation burden in clinical trial protocols.
- This research builds upon the Tufts CSDD-ZS Patient Burden Algorithm.
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