The FACILITATE webinar on the Return of Individual Participant Data, which took place on 25 June, is now available online.We invite you to follow our Stakeholders Virtual Roundtable, with 379 people registered and 186 participants (Patients, Companies, Researchers, CROs, Health institutions& regulators) from 35 countries. A rich and engaged discussion involved the attendees, who expanded the conversation with interesting questions and comments.
Johanna Blom, Professor of Psychobiology Pediatric & Behavioral Neuroscience, University of Modena and Reggio Emilia (UNIMORE), and IHI FACILITATE Coordinator, opened the works with an exhaustive and interesting scenario of the project.
Then, Ciara Staunton, legal academic and independent consultant at UNIMORE, with extensive international experience, presented the state of the art, focusing on the legal and
ethical frameworks needed to support RoIPD from the start of study design that FACILITATE is developing. “These conversations are essential to ensure research respects participants’ rights and builds trust in data sharing” concluded Ciara “It is a critical discussion on embedding participant data return into the core of clinical research.
The panel discussion moderated by Nuala Ryan, Takeda, Public Private Partnership Team, Clinical Research Consultant and Patient Advocate, included two patient representatives: Moenia Koukougianni, Patient Advocate, NGO Consultant, Strategic Communicator, and EUPATI Fellow, and Nadia Malliou, President of Pain Alliance Europe. Their voice has been critical in understanding the needs and expectations of patients on such a topical issue as individual clinical trial data return.
With more of 20 years of experience in strategic communication and advocacy, Moenia focused on how better patient education and communication can truly empower
individuals, why building trust in health data systems is essential, and how aligning national data laws with the project’s goals can ensure smoother and more inclusive implementation.
Nadia brought a unique dual perspective to the discussion, as both a chronic pain patient and researcher. “When patients are given access to their clinical data, they gain the power to make better decisions and participate more actively in their care.” She stated “But for return of individual participant data to work, we need standardized, safe, and truly patient-friendly systems. That includes overcoming health literacy barriers, building trust, and ensuring post-trial support, not just ticking a box.”
Equally paramount to the articulated discussion were Swapna Pothula, Associate Director, Data Strategy & Management at GSK, Daniele Gennaro, Research and Development
Manager, Clinical Trial Center, Policlinico A. Gemelli, Italy and Luca Pani, coordinator of FACILITATE and former director General of the Italian Medicines Agency (AIFA), member of the Committee for Human Medicinal Products (CHMP) of the EMA.
