EU-X-CT

The European cross-border access to trials initiative is a multi-stakeholder public-private–partnership co-led by EFPIA and the European Forum for Good Clinical Practice. It aims to enable cross-border access for patients to clinical trials when there is no option for them to join a trial in their own country. The EU-X-CT initiative has over 100 members in 28 European countries. 

Patients and healthcare professionals across Europe face high hurdles when attempting to access clinical trials in another country. This is particularly a problem for rare diseases and for diseases in children, where patients often need to travel to specialised hospitals or consult experts that may not be available in their home country. The lack of a European legal framework for cross-border clinical trials means that each case must be negotiated individually, often requiring substantial administrative, logistical, and financial effort by both patients and investigators. This can often delay or even prevent patients’ access to potentially life-saving treatments. 

Members of patient organizations, academic institutions, research networks, Ethics Committees, Regulatory bodies, pharmaceutical companies, contract research organizations and health insurance institutions have all provided input to the recommendations on cross-border access drafted by EU-X-CT. Having such broad contributions from both public and private sectors means that the recommendations reflect the views of multiple stakeholders across Europe. 

By publishing recommendations on cross-border access to clinical trials, the EU cross-border trials initiative has, for the first time, provided a concise, practical guide for clinical researchers who are considering cross-border approaches in their trials. Topics covered include:

• Considerations for sponsors and investigators that highlight the importance of upfront planning at the protocol development stage to minimize additional burden on sites and participants 

• Trial site aspects such as Ethics Committee requirements, IT infrastructure, data protection, language capabilities, communication through translators and translation of medical documents 

• Ethical recommendations include ensuring adequate informed consent and communication – also with the treating physician in the participant’s home country 

• Other important topics covered are: liability insurance; covering costs for accommodation, travel and meals; supply of trial medication; safety recommendations; follow-on care when participants return home. 

In addition, country specific information that is available on the EU-X-CT website gives valuable insights on national aspects for cross-border trial participation as well as useful information for patients

EU-X-CT website: https://eu-x-ct.eu/