Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
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Synopsis
Tapping into existing community connections can help jump-start patient feedback. Also consider building new relationships to better engage underrepresented patient and caregiver communities and support diversity.
Questions To Ask
- Is the study flow burdensome for patients?
- Do the inclusion/exclusion criteria reflect the real-world patient population?
- Is the study objective aligned with an unmet patient need?
- How often are patients assessed, and is this frequency manageable?
- Are visit schedules and assessments aligned with real-world care patterns?
- What options are available if a patient’s condition worsens during the study?
- What barriers may limit participation, and how can they be addressed?
- What compensation and support (e.g., travel, time) may help reduce patient burden?
Why involve patients and caregivers now?
As additional elements of the protocol take shape, patients and caregivers help ensure that each component is purposeful, relevant, and presents an acceptable level of burden.
This stage also allows refinement of study logistics to better align with real-world patient experience and improve recruitment and retention.
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