Patient Protocol Engagement Toolkit

Consider:

• Do you have previous experience in this patient population/indication?
• What is your patient population & where are they (e.g., geography, specialty, any cultural issues to address)?
• What are the objectives of your patient engagement activity?
• What is the best engagement method?

What are the specific questions you want answered? (e.g., understanding of patient journey, assumptions vs. real life, medical practice pattern)

• Do you have key design elements that may negatively impact the patient (schedule of assessments)?

Consider any study-specific needs (e.g., ePRO, draft ICF, drug packaging, use of devices)

Define roles & responsibilities

• Consider appointing a Patient Engagement Lead who will manage the patient insights work, and engage with the internal team and relevant stakeholders