FACILITATE meets in Paris

On June 8 and 9 the Semi-Annual Meeting 2023 of FACILITATE took place in Paris, nearly one and a half year since the virtual kick off. It was a successful roundup focusing on interactive work meetings in smaller groups and complemented by plenary sessions.

FACILITATE hosted a hybrid event with more than 50 participants from public and private partners.  The meeting was chaired by Véronique Poinsot (Sanofi), Prof. Johanna Blom (Modena and Reggio Emilia University) and Philippe Bordes (Sanofi). The two days meeting focused on the ethical, legal, and operational challenges posed for clinical trial data return to participant and the secondary use of these data.

Sylvain Nicolas (Sanofi Head of Clinical and Sciences Operations) introduced the meeting with his view on the importance of such initiative for patients and for industry, describing changes that occur on patients’ life with digital help and specifically in clinical trials. He focused on decentralization and digital biomarkers as examples with still high variability across EU countries.

Plenary sessions were organized to display information on key areas for clinical trials.

• The patient perspective was presented and discussed as it drives the vision of the consortium and the ongoing consultations process through the Patient Expert Group (DAG+), including 20 persons.
• The clinical trial data workflow was examined, highlighting the importance of a high-quality process using CDISC standards and other up to the data submission to the health authorities.
• The federated data model was developed to review challenges and opportunities that the project can benefit.
• Clinical data return initiative under TransCelerate initiative was presented to the team, crystalizing the importance of bridging both projects.
• Pfizer shared with us the program they are launching at the end of the month in the US on returning clinical trial data to participants, an experience that represents a good process to build upon and enrich with the variety of FACILITATE partners (patients’ organizations, medical research centers, digital companies, and pharmaceutical companies).

Breakouts sessions were set up to facilitate interactions between all actors. They allowed to confront points of view and push boundaries related to legal, ethical and operationalization for clinical trials data return and secondary use of data.

This was also the time to test the ethical framework proposed by WP3 in use cases sessions inspired by real cases encountered. On each session one leader explained the objectives, the approach, the use case, and the methodology to discuss the process and workflow suggested by WP3. The leader was supplemented by a facilitator who helped the moderation of the session. At the end of each session all the contributions from each group were restituted to all partners.

The Sustainability Working Group’s overall aim is to come up with a plan for how the outputs from FACILITATE can be sustained after the project ends, presenting the first vision of the plan.

The communication team reviewed the Glossary for patient initiative, aiming to provide a list of key-terms for patients through a dedicated page on FACILITATE website, with an understandable, simple, and not technical content.

At the end of all these sessions the team gained clarity on ethical, legal, and operational challenges and get back to work to enrich drafted documents to propose an adaptative process which could benefit patients.