Regulation--the real threat to clinical research

doi:10.1136/bmj.a1732

Published 16 October 2008, doi:10.1136/bmj.a1732
Cite this as: BMJ 2008;337:a1732

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Regulation—the real threat to clinical research

Paul M Stewart, professor of medicine¹, Anna Stears, specialist registrar in clinical pharmacology and endocrinology², Jeremy W Tomlinson, Wellcome trust clinician scientist fellow³, Morris J Brown, professor of clinical pharmacology¹^,2

¹ University of Birmingham, Birmingham, ² Addenbrookes Hospital, Cambridge CB2 2QQ, ³ Division of Medical Sciences, University of Birmingham

Correspondence to: M Brown m.j.brown@cai.cam.ac.uk

Recent changes to research governance were intended to ensurethat clinical trials are safe and effective. But Paul Stewartand colleagues argue that the regulatory burden is now obstructinghigh quality science

The first 150 words of the full text of this article appear below.

Personal experience and feedback from many clinical researchersindicates that a major hurdle to undertaking clinical researchis the ever increasing bureaucracy attached to the process.It is now the biggest single threat to the UK clinical researchbase and warrants immediate action. Earlier threats—lackof researchers and capacity—have been addressed throughmajor investment by interested parties including the MedicalResearch Council, Wellcome Trust, other charities, and the Departmentof Health. However, anyone taking up one of the new academicspecialist registrar posts created to encourage clinical academictraining is likely to spend the entire 12 month fellowship tryingto obtain regulatory approval for any clinical research project.Drug companies are experiencing similar difficulties. The UKhas slipped from one of the most attractive to one of the leastattractive places to undertake clinical trials as a result ofignoring warnings at the start of the decade that companiescannot . . . [Full text of this article]

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This article has been cited by other articles:

Hey, E. (2009). Managing allegations of research misconduct. JRSM 102: 134-138 [Full text]
Vlassov, V. V (2009). Over-regulation, Russian style. BMJ 338: a3141-a3141 [Full text]
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Cascorbi, I., Orme, M., Cockroft, J. R, On behalf of the EACPT Executive Committee, (2008). A UK problem. BMJ 337: a2919-a2919 [Full text]
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Rapid Responses:

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