The Guild calls for the European Union to remove barriers for conducting multinational clinical trials
This week, the EU member states will discuss how to best coordinate their responses to cross-border health threats. The Guild highlights that lessons from the COVID-19 pandemic must be drawn in this regard and that the EPSCO Council and the Working Party on Pharmaceuticals and Medical Devices should give a stronger impetus to initiatives aimed at facilitating larger and multinational clinical trials. We urge the member states and the European Commission to address critical obstacles that researchers are facing when conducting multinational clinical trials, particularly regarding the sharing and reuse of health data.
In January, the Clinical Trials Regulation entered into force, aiming to create a more favourable environment in the EU for carrying out clinical research on a large scale. Building on the regulation, the Commission, together with the Heads of Medicines Agencies and the European Medicines Agency, also launched the initiative ‘Accelerating Clinical Trials in the EU’ (ACT EU) to better integrate clinical research in the European health system. The Guild welcomes these initiatives as well as the Clinical Trials Information System (CTIS) platform that was launched in January, enabling clinical trial sponsors to submit streamlined and single applications even for clinical trials carried out in multiple countries.
However, while CTIS will help the conduct of multinational clinical trials, it will be insufficient in addressing all the existing obstacles researchers currently face regarding clinical trials. The General Data Protection Regulation (GDPR) and the inadequately harmonized interpretations of its provisions across member states impose fundamental limitations on the sharing and reuse of health data for research purposes.
As The Guild has highlighted previously, the uncertainties have caused researchers to avoid sharing and reusing health data for research purposes to ensure compliance with the GDPR rules. This poses major challenges for clinical studies. Therefore, it is crucial that the European Health Data Space complements CTIS by providing solutions for the exchange of health data.
Crucially, the scope of the new regulation and CTIS should also be expanded to include medical devices, as the capacity of European researchers to conduct cross-border assessment of these devices is equally crucial to ensure that citizens have access to innovative and safe care in Europe.
Jan Palmowski, Secretary-General of The Guild of European Research-intensive Universities, said: “The inabilities to conduct large and multinational clinical trials and to share data from clinical studies across border impose severe limitations on our researchers’ ability to improve patient care and develop new medicines. This puts European health research at a competitive disadvantage globally. More importantly, it is to the detriment of patients who will be denied the medical innovations that could be enabled by better exchange of health data.”
28 March 2022