D19.3 Report describing recommendations for activities to increase the attractiveness of Europe for performing clinical trials

EXECUTIVE SUMMARY

Enhancing Europe’s attractiveness as a destination for clinical trials is vital to sustaining its global competitiveness in medical research, improving patient access to innovative therapies, strengthening global healthcare systems and fostering economic growth. Despite Europe’s scientific excellence, fragmented regulations, administrative burdens, and inconsistent national practices continue to hinder the efficiency and appeal of conducting trials across Member States. Addressing these challenges requires a coordinated, strategic approach at both EU and national levels.

In line with ERA4health’s strategic objectives:
•Supporting relevant medical research including clinical fields and intervention areas (prevention, diagnosis, treatment)
•Building capacity, in particular in conducting IICS at EU scale,

the purpose of this report is describing potential activities (recommendations) to be undertaken both at general level and during the ERA4Health partnership, based on hurdles identified as part of D14.1 “Report on Bottlenecks to multicountry IICS”.

Key priorities include promoting well-designed and adequately funded multinational trial calls, streamlining national and European Commission procedures, and investing in modern trial methodologies such as adaptive, platform, and decentralized designs. Strengthening digital health capabilities—through toolkits for remote monitoring, eConsent, and interoperability between hospital systems and trial platforms—will increase efficiency and patient participation. Greater patient involvement in research development, supported by EU-level advisory boards and harmonized ethics review processes, will ensure that trials are feasible, inclusive, and aligned with patient needs.

Europe must also build capacity through trial readiness certifications, harmonized site feasibility platforms, and standardized trial agreements. Financial and regulatory support—such as mechanisms for access to investigational products, tax incentives, and model insurance frameworks—can further empower non-commercial and investigator-initiated trials. Finally, establishing an EU-wide standard for clinical trial data sharing, linked to the Clinical Trials Information System (CTIS) or the European Health Data Space (EHDS), will enhance legal certainty, reduce compliance burdens, and encourage participation in multicenter, data-driven research.

Together, these measures will create a more integrated, agile, and patient-centered clinical research ecosystem across Europe.