Patient and Caregiver : Draft Protocol

Trial Design Stage

Published Date: April 29, 2025

Share to:

Helpful Terms and Definitions

ClinicalTrials.gov Glossary Terms

NIH Glossary of Common Terms

FDA Drug Development and Review Definitions

Resources*

*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.

Draft Protocol

Patients and caregivers often have the greatest impact at this stage of design, where detailed protocol elements can still be refined to better reflect real-world experience.

Questions To Ask

How can discussions be structured to capture diverse patient perspectives, recognizing that individual experiences may vary?
Do patients and caregivers feel they are in a safe environment where they can share honest, unfiltered feedback?
Is there an opportunity for cross-discussion to build on ideas and explore different perspectives?
Can patient organizations help facilitate advisory discussions and strengthen community trust?
If third-party vendors are used, is communication transparent and bi-directional?
Which parts of the protocol or participant-facing materials are confusing or unclear?
Are participant instructions easy to understand and written in plain language?
Are risks, expectations, and time commitments clearly explained?
Do assessments and visit schedules fit into real-world routines?
Do any procedures feel too invasive, too frequent, or unnecessary?
Are there operational barriers (e.g., childcare, mobility, comorbidities, caregiver dependence)?
Are there obstacles to participation that may not have been anticipated?
Are there accessibility challenges (e.g., transportation, technology, cost, caregiver support)?
What options are available if a patient’s condition worsens during the study?

Why involve patients and caregivers now?

Engaging patients and caregivers during draft protocol development helps ensure the study is both meaningful and feasible from a real-world perspective.

This stage provides an opportunity for detailed, actionable feedback on study design, helping to reduce patient burden, improve clarity of materials, and strengthen overall usability. Incorporating this input can improve recruitment, retention, and participant experience.

Sponsors should also seek feedback on all patient-facing materials, including consent forms, instructions, and educational resources.

Obtaining and integrating patient and caregiver input during protocol finalization

A structured process can be used to: