Breaking down barriers: Making cross-border access to clinical trials a reality

The EU-X-CT Cross-Border Clinical Trials Initiative, co-led by the European Forum for Good Clinical Practice (EFGCP) and EFPIA, is dedicated to enhancing access to cross-border clinical trials in Europe. This initiative focuses on identifying barriers to participation in cross-border clinical trials and developing recommendations to overcome these challenges. Volunteers from diverse stakeholder groups, including patient organisations, academia, research networks, and industry, are actively involved in the initiative.

On 12 April 2024, EU-X-CT organised its first Public Stakeholders’ Forum in Brussels, Belgium. This event brought together various stakeholders to discuss the issues related to patient participation in clinical trials across EU borders. The forum featured several panel discussions with regulators, Commission representatives, patients, and investigators sharing their perspectives on enabling cross-border access to clinical trials.

At the conclusion of the meeting, the EU-X-CT leadership proposed a six-point action plan to guide future steps:

  • Define minimal ethics committee requirements.
  • Develop recommendations for industry and academic sponsors as well as contract research organisations (CROs).
  • Formulate guidelines for investigators and clinical trial sites.
  • Clarify cost coverage responsibilities of health insurance companies and payers.
  • Determine liability insurance coverage parameters.
  • Increase awareness among patients and treating physicians.

EU-X-CT has also published a comprehensive summary of the key insights from the Public Stakeholders’ Forum, available on the EU-X-CT website.

The initiative is now working on drafting recommendations for cross-border trial access based on feedback from EU-X-CT surveys and discussions at the Stakeholder Forum. These recommendations are expected to be shared for public comment by the end of 2024.