The Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem (FACILITATE) is a new Innovative Medicines Initiative (IMI) funded project to find an ethical and GDPR compliant framework for returning clinical trial data to study participants, a key step in reconciling the promise of avoiding useless repetitions of studies with privacy rights of individuals. VeraSci will serve on the Medical and Technical Expert Decision Committee for the project. Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci will serve as the Project Coordinator in his role as Professor Pharmacology and Clinical Pharmacology at the University of Modena and Reggio Emilia in Italy.

About FACILITATE

There has been growing concern that the EU General Data Protection Regulation (GDPR) safeguards will make Europe non-competitive in the innovative drug development space. Here are a few ways GDPR may complicate clinical trials in drug development:

  • The principle of data minimization may preclude machine learning
  • Privacy by default and design may preclude predictive analytics
  • Clinical data reutilization requires access to enough “detailed information,” which GDPR restrictions could make difficult or impossible

In addition to creating an ethical and GDPR compliant framework to return clinical trial data to study participants, FACILITATE seeks to:

  • Find legally robust and ethically forward-looking ways to allow patients’ data to be accessed, used, and re-used
  • Generate a partnership where patients are at the center of data governance
  • Show how a patient-centered data-driven approach can make the entire drug development and approval process better
  • Avoid storing clinical data in siloed systems where there is no possibility to use them beyond their original (and often single-sided) purpose