Incorporating patient burden assessments into clinical trial feasibility and planning
Key takeaways
- Patient burden in clinical trials extends beyond visit counts and procedures. It includes the anticipated and experienced physical, emotional, financial, relational, communication and systemic effects of trial participation beyond standard-of-care activities. Clinical trial feasibility teams need a shared definition to assess and reduce burden consistently.
- Patient burden assessments should combine benchmark data with direct patient input. The ZS Clinical Feasibility Consortium’s updated framework compares trial demands with analogous studies and patient tolerance while adding factors such as compensation and emotional or mental strain. This helps sponsors design trials around what patients can reasonably manage rather than simply matching industry averages.
- Patient burden must be built into protocol design, governance and operational planning. Sponsors can use burden insights to inform enrollment forecasts, retention, site selection, protocol development and resource allocation. Clear decision rights, embedded KPIs, burden champions and feedback loops help turn patient burden analysis into better clinical trial decisions.
Clinical trial sponsors increasingly recognize that reducing patient burden is both an ethical responsibility and an operational necessity. Yet many organizations still assess burden inconsistently, making it difficult to connect the participant experience with recruitment, retention, timelines and cost.
Drawing on the work of the ZS Clinical Feasibility Consortium—which brings together ZS and leaders from 15 pharmaceutical sponsors—this white paper examines how sponsors can move from measuring burden to using those insights in trial design and operational planning. It introduces an updated framework to reduce patient burden that considers often-overlooked factors such as compensation, emotional and mental strain and patients’ tolerance for specific trial demands.
What your organization needs to make progress on patient burden
Patient burden progress depends on three connected elements: tools; process and governance; and people. Read the white paper to learn how you can:
- Expand burden assessments beyond visit counts and procedure frequency
- Present findings in terms that resonate with clinical development and clinical operations leaders
- Embed burden insights earlier in protocol, program and feasibility decisions
For clinical development, feasibility and clinical operations leaders seeking more patient-centric and efficient trials, this paper offers a practical path forward. It explains how burden champions, embedded performance indicators, feedback loops and clear decision rights can help sponsors make patient burden a repeatable part of trial planning.
