Regulation—the real threat to clinical research

I read with sympathy the problems of Dr Stewart and colleagues and
their application for research approval. I can easily trump their delay of
one year with my study. For this randomised trial of general versus
regional anaesthesia for hip fracture surgery, we were first asked to have
MHRA approval. This was applied for in November 2004 and in October 2005
they replied stating that MHRA approval was not necessary for this
particular study. Ethical approval was sought in October 2005 and granted
in February 2007. The R&D application was made in February 2007 and
approved in June 2007. The study commenced in June 2007. Total time for
regulatory approval two years eight months, can anybody beat that?

Competing interests:
None declared