Can Harmonized Regulation Overcome Intra-European Differences? Insights from a European Phase III Stem Cell Trial
Reason for embargo
This is the author accepted manuscript. It is currently under an indefinite embargo pending publication by Future Medicine. 12 month embargo required upon publication.
Harmonized regulation of research with human stem cells in Europe has shaped innovation in regenerative medicine. Findings from a Phase III academic clinical trial of an autologous cell procedure illustrate the obstacles a multinational trial faces. A typology of the obstacles encountered, may help other teams embarking upon trials. The findings throw light on the situation of clinician-scientists in clinical innovation, as the expertise to run scientific trials is very complex. The innovation route of clinical translation takes insufficient account of the interdependencies between multiple social and cultural factors from outside the laboratory and the clinic. For ethical reasons, however, academic and business routes to stem cell treatments ought to be enabled by the regulators. Suggestions arise: how academics can prepare for trials, that academic research needs better institutional support, and that new models of medical innovation may need to be developed for regenerative medicine.
I thank the BAMI team for its consistent and generous cooperation, especially the support of the trial coordinator Prof. Anthony Mathur at Queen Mary University, London, and Sheik Dowlut at the BAMI trial office is gratefully acknowledged. I also thank Dr. Jean Harrington and Dr. Nicole Baur for their assistance with the empirical data collection. This research was funded by the European Commission under the Seventh Framework Programme, HEALTH, Grant agreement number 278967.
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