Patient and Caregiver : Draft Protocol

Trial Design Stage

Published Date: April 29, 2025

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Helpful Terms and Definitions

ClinicalTrials.gov Glossary Terms

NIH Glossary of Common Terms

FDA Drug Development and Review Definitions

Resources

Draft Protocol

Patients and Caregivers can have the most impact at this stage of design

Questions To Ask

Ask questions to understand patient experiences, understanding and accepting that an individual's perspective is subjective and will likely differ from future patients
Consider whether the patient/caregiver feel they are in a safe environment where they are able to share thoughts and honest opinions in an unfiltered fashion?
Is there an opportunity for cross-talk to build on thoughts and different perspectives?
Can a patient group facilitate advisory boards and other study design discussions, supporting community trust and optimal feedback?
Use of third party vendors is also an option provided that the sponsor is fully transparent and fosters bi-directional communication.
Which parts of the protocol or associated materials are confusing or unclear?
Are the instructions for participants easy to understand?
Are risks and commitments explained well in plain language?
Do the assessments and schedule fit into real‑world routines?
Do any procedures feel too invasive, too frequent, or unnecessary?
Are there are operational barriers (childcare, mobility, comorbidities, caregiver dependence)?
Are there obstacles to participation you may not have anticipated?
Are there any accessibility concerns (transportation, technology, cost, caregiver needs)?

Why involve Patients and Caregivers now?

Engagement of patients and caregivers in development of the draft protocol ensures the study will enact meaningful change without being overly burdensome for patients, enhancing the likelihood of robust enrollment. This is the first opportunity where patients and caregivers can provide specific, pointed feedback on study design. In addition to the draft protocol, sponsors should review and gain patient feedback on any literature/applications that will be patient-facing.