A framework for multi-centre clinical studies could offer broad benefits, research universities say
The EU should use its forthcoming pharmaceutical strategy to make it easier for academic researchers to do multinational clinical studies, a university group has said.
Currently, there is no EU platform to recruit colleagues abroad to join a clinical study, regulations make it hard for academics to start multi-centre trials, and the EU’s data protection rules make passing data between centres painful or impossible, according to the Guild of European Research-Intensive Universities.
Responding to a European Commission consultation on the EU pharmaceutical strategy, the Guild called for a European Framework for Multinational Clinical Studies that would keep pace with innovation and be easy to use for public sector researchers.
“A European framework for conducting multinational clinical studies, including traditional randomised trial designs, observational studies on large-scale biometric databases, and pragmatic adaptive study approaches would contribute to strengthen Europe’s position as a global leader in healthcare research,” it said.
The strategy should make regulations and regulatory systems more accessible for academics, the Guild said in a response paper it published on 15 September, adding that the Commission must also set aside funding in the 2021-27 EU R&D programme, Horizon Europe, to support academically led clinical studies.
Coordinated data collection across borders is a big part of early and later-stage clinical studies, the group said, noting that academic-led work faces higher hurdles than that from industry.