ABOUT

FACILITATE

OBJECTIVES OF THE FULL PROJECT

  • Implement best practice for handling personal data protection regulations
  • Nurture the harmonization of an ethical and legal framework applicable to medical research in the Member States
  • Deliver a prototype process for returning clinical trial data to study participants and to facilitate the conduct of health research projects, during and after the study
  • Generate recommendations on which, when and how data should be returned to study participant
  • Develop insights on how this data could be used in health care decision making and for future research
  • Ensure that the whole data process is legally compliant and aligned with the study participants’ voice

AMBITION OF FACILITATE

  • Avoid the current situation where, especially in Europe, data from clinical trials are siloed in separate medical systems islands without any possibility to be used beyond their original and often limited single-sided purpose
  • Create new legal and ethical tools to allow patients’ data to be accessed, used, and re-used, and clinical trials to be run
  • Generate a partnership in which patients are at the centre of data governance thanks to advanced communication tools and participatory technologies
  • Provide clear rules in a trusted ethical, legal, and regulatory ecosystem to strongly engage patients as data generators
  • Bring effective and safer medicines faster at their approval date