Challenges to learning in clinical research: Networked innovation within a regulatory regime

This paper considers how the organisational and institutional arrangements – particularly the regulatory context-that surrounds the clinical research process influences biomedical innovation and restricts the opportunity for learning to take place. We explore how different stakeholder and collaborating groups engage in inter-organisation learning within this field, and, in particular, consider the effects of power interplays at the interstices of these different groups involved. One stakeholder group-the global pharmaceutical industry-is particularly powerful within the network. Their model of clinical research – the Randomised Controlled Trial (RCT) – has been adopted to largely structure the regulatory regime. This, coupled with the power that regulatory groups yield within the clinical research process, means that other groups who use different models of clinical research find it difficult to integrate knowledge about the specific attributes of their research, and so have relatively little influence with regards to shaping the regulatory regime to better fit their type of research. We describe how, in this context, knowledge sharing and learning is highly informal, ad hoc and localized, as less powerful groups strive to find ways to conform to the strict regulatory regime within which they operate. However, this ultimately limits the type of innovation that occurs within the UK context, as research using non-standard models are limited by the extent to which they can integrate knowledge about their exceptional context through the network of stakeholders and reshape the system to enable their novel research design to be able to proceed within it.