WP 5 – Ethics and engagement with regulatory groups, agencies and other stakeholders

There is a need to involve end users, ethics experts and regulators in decisions that relate to clinical protocols, assessments, and ecological outcomes. Effective use of all data and biobank materials already acquired and yet to be acquired following strict ethical parameters is an important issue in collaborative research in different countries. Clinical trial use of digital biomarkers for population stratification is an innovative development methodology that will require further interaction with regulators including scientific advice from the European Medicines Agency (EMA) and agreement on the necessary steps for future qualification. WP5 will therefore take care of three main aspects of PRISM 2 structure and outreach:

  • Ethical requirements for the work undertaken by PRISM 2
  • Implementation of a strategy to continue and strengthen the collaboration with patients, learned societies, and health care providers to ensure that project results have an impact on future clinical trials and health care practices
  • Expansion of initiated dialogue with the EMA to determine how to best support the progression and validation of a promising digital biomarker from our trans-diagnostic approach and to advice on the design and conduct of the studies planned in WP3