title: Regulation and governance of multinational drug trials in stroke: barriers and possibilities.
abstract: Over the last 10 years, there has been stagnation in the number of multinational drug trials in stroke in Europe. One important cause of this is probably the increased burden of laws and regulations that came with the European Union Clinical Trials Directive. The main objective of research regulation and governance should be to protect research participants, their tissues, and data, but the approval systems are complex, regulation is variably interpreted and enforced, and the assessment of studies is often not proportionate to the risk of the research to participants. Such unnecessary barriers should be reduced by simplifying, centralizing, and harmonizing the application process, and by applying regulatory and governance requirements in a way that is proportionate to the potential harms to the patients. The traditional functions of a regulator (in setting, monitoring, and enforcing quality standards) could also be supplemented with an aim to actively help researchers achieve these standards, for example, by giving advice, and ultimately with an aim to facilitate and promote research, for example, by integrating research in everyday clinical practice. Research networks offer one way of integrating research and clinical practice across multiple centers, and can streamline research delivery by supporting researchers deal professionally and efficiently with the regulations and governance requirements.
authors.affiliation: Department of Internal Medicine, Oslo University Hospital, Oslo, Norway.
authors.forename: Eivind
authors.initials: E
authors.lastname: Berge
authors.forename: Gary A
authors.initials: GA
authors.lastname: Ford
authors.forename: Philip M W
authors.initials: PM
authors.lastname: Bath
authors.forename: Christian
authors.initials: C
authors.lastname: Stapf
authors.forename: H Bart
authors.initials: HB
authors.lastname: van der Worp
authors.forename: Jacques
authors.initials: J
authors.lastname: Demotes
authors.forename: Joseph
authors.initials: J
authors.lastname: Broderick
authors.forename: Rustam
authors.initials: R
authors.lastname: Al-Shahi Salman
authors.forename: Kennedy R
authors.initials: KR
authors.lastname: Lees
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000379:methods*; D006801:Humans; D007391:International Cooperation; D020521:Stroke / Q000188:drug therapy*
keywords: : multinational research; regulatory barriers; stroke trials