"Ethical harmonization across space: logistic and regulatory issues in implementing a multi-national clinical trial" - Prof Christine Hauskeller & Nicole Baur (UoE)

In this talk we report findings from an empirical investigation of the process in which a stem cell clinical trial is being implemented across 10 European countries. As part of a clinical trial team, we had the unique opportunity to study implementation – including its events and problems - while it happened. Obstacles for swift patient recruitment across clinical sites arose for a variety of reasons, but most are related to the minute standardization of practice which is the basis for the scientific approach in medicine that identifies clinical trials as ultimate evidence for clinical efficacy. We identified differences in resource management and in locally entrenched daily routines of patient care, but also in the practical implementation of regulations and insurance requirements, for example, which as such relate back to specific understandings of best practice in clinical care. Our findings show that the policies developed to harmonise medical practice and clinical trials in Europe can lead to serious delays before patient recruitment even starts. We especially focus on problems with the logistics and technological requirements following European Medicines Agency (EMA) regulations and the effects of the Voluntary Harmonisation Procedure (VHP), a protocol aimed at simplifying multinational ethics approval of general agreements which depend on both trust and coherence in other policies.