“A trial that excludes most patients is not evidence—it's oversight."
Despite decades of progress in clinical research methodology, most trials still fail to reflect the diversity of the populations they intend to serve. Stringent eligibility criteria, urban-centric infrastructure, and outdated models of informed consent contribute to the systematic exclusion of older adults, rural residents, ethnic minorities, and patients with comorbidities. The result is a body of evidence that is scientifically rigorous but often clinically incomplete.
This session will present the blueprint for trial modernisation in high-income settings, drawing on leading examples such as EU-supported initiatives that integrate decentralised recruitment, real-world data (RWD), and AI-driven patient matching. These models have proven that inclusivity and scientific robustness are not mutually exclusive.
We will examine the role of interoperable patient registries, and pan-EU ethics harmonisation in enabling cross-border trial participation. In particular, we will highlight examples from EATRIS, the European Medicines Agency (EMA), and Horizon Europe-funded trial networks that are demonstrating how technological and regulatory innovations can reduce trial setup times, increase recruitment efficiency, and deliver more generalisable evidence.
The session will also explore the integration of patient-reported outcomes (PROs) into trial design, and the ethical implications of real-time monitoring tools. The goal is to ensure that trials do not merely generate results, but that they inform treatment decisions with meaningful, real-world relevance.
Conclusion:The future of evidence generation lies in clinical trials that reflect the lived reality of patients. Policy frameworks, ethics standards, and digital infrastructure must evolve to support a trial ecosystem that is inclusive, decentralised, and designed for impact.
