Bureaucracy is strangling clinical researchBMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l1097 (Published 13 March 2019) Cite this as: BMJ 2019;364:l1097
- Simon Rule, professor of haematology1,
- Steven LeGouill, professor of haematology2
- 1Plymouth University Peninsula Schools of Medicine and Dentistry, UK
- 2University of Nantes, France
Clinical research is fundamental to the advancement of medical practice and improving outcomes for patients. This is without question, but evidence based medicine requires the generation of evidence and it is this process that has evolved to a place where it may become self defeating.
Year after year, clinical research teams and investigating physicians are subjected to an exponential growth in the administrative burden, paperwork, and regulation associated with clinical trials. The law has not appreciably changed since 2001, but those administering it or working within it are producing more bureaucratic demands. The universal explanation for this increasing workload is that it represents “good clinical practice” and is there to support the safety of the patient and the integrity of the research. It is impossible to disagree with those aims, however this deluge of …