Analysis Personal Paper

Regulation—the real threat to clinical research

BMJ 2008; 337 doi: http://dx.doi.org/10.1136/bmj.a1732 (Published 16 October 2008) Cite this as: BMJ 2008;337:a1732
  1. Paul M Stewart, professor of medicine1,
  2. Anna Stears, specialist registrar in clinical pharmacology and endocrinology2,
  3. Jeremy W Tomlinson, Wellcome trust clinician scientist fellow3,
  4. Morris J Brown, professor of clinical pharmacology12
  1. 1University of Birmingham, Birmingham
  2. 2Addenbrookes Hospital, Cambridge CB2 2QQ
  3. 3Division of Medical Sciences, University of Birmingham
  1. Correspondence to: M Brown m.j.brown{at}cai.cam.ac.uk
  • Accepted 13 August 2008

Recent changes to research governance were intended to ensure that clinical trials are safe and effective. But Paul Stewart and colleagues argue that the regulatory burden is now obstructing high quality science

Personal experience and feedback from many clinical researchers indicates that a major hurdle to undertaking clinical research is the ever increasing bureaucracy attached to the process. It is now the biggest single threat to the UK clinical research base and warrants immediate action. Earlier threats—lack of researchers and capacity—have been addressed through major investment by interested parties including the Medical Research Council, Wellcome Trust, other charities, and the Department of Health. However, anyone taking up one of the new academic specialist registrar posts created to encourage clinical academic training is likely to spend the entire 12 month fellowship trying to obtain regulatory approval for any clinical research project. Drug companies are experiencing similar difficulties. The UK has slipped from one of the most attractive to one of the least attractive places to undertake clinical trials as a result of ignoring warnings at the start of the decade that companies cannot afford long delays in approval and initiation.1 2 We illustrate the effect of recent regulation with two anecdotes from our experience.

Case 1

In November 2004, AS sought ethical approval (under the old system) for a single centre, double blind, placebo controlled crossover comparison of glucose tolerance in two established classes of antihypertensive drugs, beta blockers, and thiazide diuretics. The ethics committee submission was approved with no changes at the end of November 2004, and approval from the trust’s research and development department was obtained in parallel. A paper request for clinical trials authorisation was submitted in early January 2005 and approved in February 2005. The first patient visit was in the same month.

In July 2007, we decided …

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