Trial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.
Final Protocol
Questions To Ask
Why involve patients and caregivers now?
Engaging patients and caregivers during final protocol development enables sponsors to close the feedback loop established in earlier phases.
This stage provides an opportunity to return to those previously engaged, demonstrate how their input influenced the study, and reinforce transparency and trust. Maintaining this connection supports long-term engagement and strengthens relationships for future studies.
How to Communicate Back to Patients and Caregivers
Patient and Caregiver Resources
Patient Focused Drug Development Guidance
Patient Protocol Engagement Toolkit
Practical How-to Guides for Patient Engagement
Paradigm Patient Engagement Toolbox
Patient Engagement Quality Guidance Tool
Framework for Patient Engagement in Cancer Network Group Studies
Representativeness in Patient Engagement
Assessing Meaningful Patient Engagement in Drug Development: A Definition, Framework, and Rubric
Assessing the Financial Value of Patient Engagement
Streamlining Patient Recruitment with AI-driven Site Identification
CTTI: Patient Group Engagement
Complete Guide to Remarkable Patient Engagement
Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
Payer