GenZ-trials

Funding programme: IHI JU (N 101252995)

Budget: €14.2M

Coordinator: Aristotle University of Thessaloniki (AUTH)

Duration: 5 years (Jan 2026 - Dec 2030)

GenZ-trials proposes a next-generation clinical trial framework that integrates data science, automation, and simulation to transform how trials are designed, conducted, and evaluated. It builds on three innovation pillars: i) Automation of critical trial workflows using generative AI for personalised informed consent, protocol drafting, monitoring, and regulatory submission, thereby reducing administrative burden and expediting trial initiation. ii) Artificial Intelligence (AI)-driven patient recruitment by analysing large-scale Electronic Health Records (EHRs), and real-world datasets to optimise matching between patients and trial protocols, improving enrolment rates, inclusiveness, and avoidance of patient dropout. iii) Integration of Digital Twins (DTs) and Synthetic Control Arms (SCAs) for protocol optimisation through in-silico simulation and enabling ethically sound alternatives to placebo groups, using real-world data to construct robust comparators with fewer enrolled participants.

GenZ-trials will provide a flexible, data-rich platform to assess pharmaceuticals, diagnostics, digital health tools, and therapeutic combinations, strengthening health technology assessment, regulatory decisions, and reimbursement. The framework will be implemented in three phases: development of core tools, retrospective emulation of historical trials, and prospective validation in a Phase IV clinical equivalence trial comparing a generic anticoagulant with its branded counterpart, establishing a more ethical, inclusive, and cost-effective model for clinical research.

ECRIN’s role in GenZ-trials

ECRIN’s main role will be extending and employing FAIR data tools, facilitating the clinical trial design and conduct and engaging different stakeholder communities (e.g., clinical researchers, policymakers) to accelerate the project’s impact.