Jessica Scott, MD, JD, and CEO of Legacy Health Strategies, joined an inspiring panel at the 2025 World Orphan Drug Congress in Boston to discuss one of the most pivotal conversations in patient-centered research today: “Ethics and Strategies for Returning Individual Patient Data Collected in Clinical Research.”
A New Era of Transparency and Trust
Alongside respected leaders Mindy Cameron (AdvocacyWorks Consulting), Suzanne Gaglianone (ReveraGen BioPharma), and Jodi Wolff (Strategic Advocacy Solutions), Dr. Scott explored the ethical imperatives and practical strategies for returning individual-level trial data to participants.
The session sparked deep engagement. Why? Because returning individual data isn’t just about compliance—it’s about empowerment, equity, and trust.
When sponsors share individual-level data:
- Patients gain actionable insights that can inform treatment decisions
- Trust is strengthened between participants and research sponsors
- Health information equity is advanced, especially in underserved communities
- Future trial participation improves through stronger participant engagement
When Data Is Withheld, the Cost Is High
When data isn’t returned, communities like Duchenne Muscular Dystrophy face confusion, anger, and distrust. The panel shared moving quotes from families who simply want to understand their own or their loved one’s experience:
🗣 “I just want to know everything I possibly can.”
🗣 “It would help us decide what to do next.”
🗣 “It would help me decide if I might want to increase or decrease the dose.”
These voices underscore a clear truth: participants don’t just want data—they need it to understand their own journey.
Moving From Intention to Action
Thanks to nearly a decade of collaboration across industry, advocacy, and regulatory communities, we now have clearer answers to the critical questions:
What data should be returned? When? And how?
Legacy Health Strategies has been at the forefront of this movement for nearly ten years. Our digital platform enables sponsors to return individual-level data ethically, securely, and at scale—whether you’re piloting a single study or rolling out an enterprise-wide initiative.
Because honoring the contribution of trial participants means closing the loop—and putting data back in their hands.
To learn more about how we can support your organization in returning individual participant data, reach out today. Let’s make this the new standard in research.
