Seamless Cross-Border Access

Our Vision for a Better Future

The EU-X-CT Initiative seeks to enable and facilitate cross-border access to clinical trials for patients in Europe and make it easier for clinical investigators to enrol patients from other European countries in their clinical trials.

We aim to map out the current status of cross-border clinical trial access conditions in each European country, detailing the legal, ethical, financial, logistical, and operational aspects, and develop recommendations to overcome current barriers.

Clinical trials are an important element of healthcare. We stand for equal access to innovation and quality healthcare for all.

Our Journey So Far

2020

An academic study as a precursor to the initiative

In October 2020, EFGCP and its consortium partners KU Leuven, EORTC and Patvocates, supported by an unrestricted grant from EFPIA, published the results of their joint research project in Frontiers in Medicine on the current situation of cross-border participation in clinical trials. The pan-European survey showed it occurs very rarely despite the clear need expressed in interviews involving patients and clinical investigators. An EU-wide legal framework defining the conditions for cross-border clinical trial access is currently lacking. European Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, does not define the conditions for accessing clinical trials in other EU Member States. This made us recognise the need for recommendations and best practices to improve cross-border access to clinical trials in Europe, which ultimately led to the launch of the EU-X-CT initiative.
2022

EU-X-CT launch

Our multi-stakeholder consortium held its kick-off meeting in November 2022 by bringing together diverse participants from various countries, professional backgrounds, and affiliations, to discuss the challenges of enabling cross-border access to clinical trials. During the meeting, the consortium discussed and agreed on the strategic approach and structure of the EU-X-CT Initiative, formulated a Work Plan for 3 Task Forces, and established milestones for the project over a two-year timeframe (January 2023 to December 2024).
2023

First milestone meeting

The EU-X-CT Initiative reached its first milestone in June 2023 when members gathered for a progress meeting in Brussels (kindly hosted by Roche) to discuss the ongoing mapping exercise activities, build synergies amongst our Task Forces, exchange experiences, and plan the next steps.

Members’ Progress Meeting

In September, members got together virtually to present the status of the ongoing mapping exercise and work together to establish the work plan - including communication and promotion strategies - to guide the Initiative towards achieving its objectives for the upcoming months of 2023.
2024

Public Stakeholder’s Forum

The Initiative’s first Public Stakeholder’s Forum, held in April in Brussels, marked a significant milestone where the future work plan was outlined through a comprehensive 6-point action plan. This plan includes the development of recommendations, as well as the finalization of data gathering and evaluation. Read the full report here.

Members’ Virtual Planery Meeting

On September 2, we held our members-only plenary meeting to discuss learnings from our Public Stakeholders Forum, enhance data collection through stakeholder questionnaires, and brainstorm ideas for sustaining our initiative via our website and other channels.

A volunteer-driven initiative

Leadership and Management

A partnership with a history of success

The EU-X-CT is co-led by EFGCP and EFPIA. The partners have a history of successful collaboration for the benefit of patients—the Good Lay Summary Practice (GLSP) Initiative, co-led by EFGCP and EFPIA, developed recommendations for lay summary practice, which were adopted by the European Commission and included in the EudraLex Volume 10 Clinical Trial Guidelines.

The EU-X-CT initiative is co-chaired by:

Dr Ingrid Klingmann
Chairman of EFGCP
Dr Susan Bhatti
Chair of Clinical Research Expert Group at EFPIA,
Director EU Global Regulatory and Scientific Policy at Merck BV
˝One of the reasons for joining [EU-X-CT] is that patient groups have been speaking about cross-border access to CT for the last five to seven years. Especially for patients from Central and Eastern Europe, access to the standard of health care and CT can be a question of life or death. It is essential to figure out the way forward. ˝ - EU-X-CT Task Force Member

Core Management Team (CMT)

We are representatives from patients/patient organisations, academia, industry, contract research organisations (CROs), and not-for-profit organisations medical societies. We coordinate, contribute, and/or lead one of the three Task Forces (TFs) to ensure seamless communication and collaboration.

The CMT also prepares the Work Plan, oversees the financial aspects, coordinates efforts to obtain support, and reviews the results achieved.

The Plenary of the EU-X-CT members decides on the Work Plan, the conclusions from the collected information including the identified gaps, and approves the jointly developed information presentation on the EU-X-CT website, the recommendations, guidelines, and follow-up activities.

˝With all these efforts of decentralization and new technologies, we are still unable to bring people, wherever they are, into the trial that they need. That is a matter of fairness, and we must work on it systematically!˝ - EU-X-CT Task Force Member

Task Forces (TFs)

The initiative is organized into three Task Forces, each consisting of representatives from the different stakeholder categories, volunteering their precious time towards our combined mission.

The Task Forces' Work Plan is organised according to the main questions the initiative is addressing:

Task Force 1 - Legal/Regulatory/Ethics Task Force 2 - Financial Task Force 3 - People/Operational
˝[I joined the initiative] so, others could have access to CT. I couldn't! ˝ - an EU-X-CT Task Force Member

Administration

For any assistance regarding project operations, administration, project management, coordination, or related matters, please feel free to contact our dedicated team members:

Project operations and administration

Bryan Michaux
bryan.michaux@efgcp.eu

Tanguy Vanderborcht
tanguy.vanderborcht@efgcp.eu

Project management and coordination

Sanda Velic
sanda.velic@efgcp.eu

Stronger Together

Our collaborators

We actively work together with various organizations and projects that share our vision and values, combining our efforts to create a more powerful alliance.


Other initiatives supporting EU-X-CT

Is your project or initiative involving the need for cross-border access to clinical trials?
Let's seek collaboration!

If you represent an organization or project that aligns with our mission and would like to collaborate, reach out to us. Together, let's work towards expanding the options for patients in Europe.