Clinical trials in regenerative medicine : negotiating process, practice and outcomes

• Main Author: Higham, Ruchi
• Other Authors: Webster, Andrew ; Genever, Pail
• Published: University of York 2017
• Subjects: 301
• Online Access: https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.739926

There has been significant progress in the basic science of regenerative medicine over the past two decades, but clinical translation has been more halting. Clinical trials are a key step in the translational process and have been highlighted as a particular challenge for the field. This thesis adopts an analytical framework informed by Jasanoff's idiom of co-production to investigate trials of one particular type of regenerative medicine: cell therapies. A mixed-methods design was used, which included quantitative analysis of secondary data, 17 semi-structured interviews with cell therapy trialists, and a longitudinal observational study of a cell therapy trial. The findings indicate that the cell therapy trials landscape in the UK is small, fragmented and dominated by academic-led, publicly-funded studies. This conflicts with a policy environment that is largely aligned with a commercial development model, and a trials process that was designed for drug trials funded by large corporations. Trials tend to be affected by a specific set of local factors, the most important being financial constraints, the logistics of working with cells, the temporality of the trial and the need to align the work of disparate domains. These issues create a challenging translational environment, with the linearity and abstracted nature of the trials process conflicting with the recursive, situated nature of innovation. They also highlight the significant contingency involved in trials, which is at odds with the priority evidence-based medicine places on this supposedly neutral, objective method. Whilst cell therapy trials must without a doubt be held to the highest regulatory standards, it is also important that the clinical research framework takes into account the challenges they pose and the contingent nature of the evidence they generate, and the thesis concludes with some recommendations as to how this might be achieved.