Can harmonized regulation overcome intra-European differences? Insights from a European Phase III stem cell trial
| Autor: | Christine Hauskeller |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Typology Embryology Academic clinical trial business.industry media_common.quotation_subject Biomedical Engineering Regenerative Medicine Stem Cell Research Phase (combat) Regenerative medicine Institutional support Social Control Formal Europe Interdependence 03 medical and health sciences 030104 developmental biology Clinical Trials Phase III as Topic Multinational corporation Humans Medicine Engineering ethics Stem cell business media_common |
| Zdroj: | Regenerative Medicine. 12:599-609 |
| ISSN: | 1746-076X 1746-0751 |
| Popis: | 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 that 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. |
| Databáze: | OpenAIRE |
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