Participation in a clinical trial is an important element of healthcare, especially for patients with life-threatening and/or rare diseases for whom a medicinal product under investigation might be the only therapeutic option.

As there is no legal EU framework that defines the conditions for accessing clinical trials in another EU member state, there is need for reliable and accessible information regarding practical aspects, as well as for multi-stakeholder, multi-national recommendations on existing options and best practice for patients, investigators and trial sponsors on conditions and options for cross-border access to clinical trials. EFGCP and EFPIA have set up a multi-stakeholder consortium of patient organisations, academics, research networks, industry and not-for-profit organisations with the aim to systematically collect available information from all European countries and to develop recommendations for enabling cross-border access to clinical trials: the EU Cross-border Trials Initiative called EU-X-CT.

Mapping Exercise

The EU-X-CT initiative aims to bring together reliable and accessible information regarding legal, regulatory and ethical as well as practical aspects on conditions and options for cross-border access to clinical trials with medicinal products (drugs) according to Article 2.2(2) of the EU Clinical Trial Regulation 536/2014(1) or respective national law. This is particularly important for patients with life-threatening and/or rare diseases for whom a medicinal product under investigation might be the only therapeutic option.

Within this Framework, the EU-X-CT Initiative has launched several mapping exercise surveys for which your input would be extremely valuable. Each of them is taking 5-10 minutes to complete, please see below.

Note: In case the survey does not load properly, please try using another internet browser (i.e. Edge or Chrome).

1. The First survey aims to map all the regulatory frameworks or legal guidance about cross-border access to clinical trials that already exist in Europe: Fill out the Survey
2. The Second survey aims to map all the different paying schemes for cross-border access to clinical trials that already exist in Europe: Fill out the Survey
3. The Third survey aims to gather information from Investigators and Sponsors/Clinical Operations Experts who have already participated or engaged in cross-border trials: Fill out the Survey

We are looking for as many answers as possible to draw out the best possible mapping of the current cross-border access to clinical trials status in Europe, further disseminating those surveys to your contacts or network would be highly appreciated.

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