Clinical trials of new medicines are key for many patients, especially those suffering from rare diseases for which no treatments yet exist or those with very serious diseases for which conventional therapy is not working. Clinical trials investigating these types of diseases are sometimes only feasible in hospitals with highly specialised resources, located in specific and limited sites.
In this sense, for many European patients in this situation, the opportunity to participate in a clinical trial is located far from where they live, and sometimes in another country. In response to this fact, the European Union took up this issue in a report on the implementation of the directive on patients’ right to cross-border healthcare in May 2022. Furthermore, an article published in Frontiers in Medicine in October 2020 revealed that such participation in cross-border clinical trials is very rare, despite the need of these patients.
It is from this reality that the Borders Should No Longer Be Barriers initiative, promoted by the Federation of the Pharmaceutical Industry (Efpia) and the European Forum for Good Clinical Practice (Efgcp), was born. The project aims to establish recommendations and best practices to improve cross-border access to clinical research, a field that is not covered by the aforementioned directive as it does not specify the conditions for access to clinical trials in other countries.
For this initiative, the two promoters have created a consortium – under the name EU-X-CT – also comprising patient organisations, representatives from academia, research networks, non-profit organisations and the pharmaceutical industry, with the aim of identifying current barriers to access and achieving better results.
The project will describe the current situation in each European Union (EU) member state, detail the logistical and financial support needed, and access issues. Recommendations will be published for public consultation and a website will be launched to share all information to facilitate cross-border access to clinical trials for European patients by mid-2024. Final recommendations, Efpia estimates, will be published in 2025.
These advances will be instrumental in bringing innovative trials to patients in countries that previously did not have access to clinical trials and thus revolutionise treatment options, especially for patients with rare or very serious diseases.
Research and development of new medicines is becoming increasingly open, collaborative and international. In this sense, Spain is one of the benchmark countries for clinical trials in the European and international context, thanks, among other reasons, to the preparation of its healthcare professionals, the support of the health authorities and the commitment of pharmaceutical companies to our country. Therefore, our country has the opportunity to lead an authentic biomedical research ecosystem in the EU.