Cross-border access for patients to clinical trials – the EU-X-CT initiative

Participation in a clinical trial is an important element of healthcare, especially for patients with life-threatening and/or rare diseases. For these patients a clinical trial may be the only available treatment option and the specialized clinics that are investigating their disease may only exist in a limited number of countries in Europe. If patients want to participate in these trials it may therefore be necessary to travel to another country. However, previous research has revealed that cross-border participation in clinical trials only occurs very rarely despite there being a high need expressed by many stakeholders. To investigate this issue, EFPIA and EFGCP have set up the cross-border trials initiative (EU-X-CT) in 2023 under the motto “Borders should no longer be barriers”. The initiative is performing a number of surveys to gather information on cross-border access to trials in Europe, in order to identify barriers and fill information gaps. This session will explain the purpose of the initiative as well as the presenting initial results from these surveys. It will also explore potential learnings and how these can be used to draft recommendations that will help inform patients, healthcare professionals and trial sponsors about cross-border access to trials.