Standards, Harmonization and Cultural Differences: Examining the Implementation of a European Stem Cell Clinical Trial

Abstract

A complex set of European regulations aims to facilitate regenerative medicine, harmonizing good clinical and manufacturing standards and streamlining ethical approval procedures. The sociology of standardization has elaborated some of the effects of regulation but little is known about how such implementation works in practice across institutions and countries in regenerative medicine. The effects of transnational harmonization of clinical trial conduct are complex. A long-term ethnographic study alongside a multinational clinical trial finds a range of obstacles. Harmonization standardizes at one level, but implementing the standards brings to the fore new layers of difference between countries. Europe-wide harmonization of regulations currently disadvantages low-cost clinician-lead research in comparison to industry-sponsored clinical trials. Moreover, harmonized standards must be aligned with the cultural variations in everyday practice across European countries. Each clinical team must find its own way of bridging harmonized compulsory practice with how things are done where they are, respecting expectations from both patients and the local hospital ethics committee. Established ways of working must further be adapted to a range of institutional and cultural conventions that affect the clinical trial such as insurance practices and understandings of patient autonomy. An additional finding is that the specific practical roles of team members in the trial affect their evaluation of the importance of these challenges. Our findings lead to conclusions of wider significance for the sociology of standards concerning how regulation works and for medical sociology about how trial funding and research directions in stem cell medicine intersect.