Register for email alerts and news feeds:
This journal | BMJ Group
rss
Journal of Medical Ethics 2006;32:430-434; doi:10.1136/jme.2005.015180
Copyright © 2006 by the BMJ Publishing Group Ltd & Institute of Medical Ethics.

RESEARCH ETHICS

Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?

L Sheard1, C N E Tompkins1, N M J Wright2 and C E Adams3

1 Leeds West Primary Care Trust, Leeds, England
2 HMP Leeds, Leeds
3 Department of Psychiatry, University of Leeds, Leeds

Correspondence to:
Correspondence to:
Laura Sheard
Centre for Research in Primary Care, 71–75 Clarendon Road, Leeds LS2 9PL, England; l.sheard{at}leeds.ac.uk

Over recent years, considerable attention has been paid to the National Health Service (NHS) research governance and ethics approvals process in the UK. New regulations mean that approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) is now also needed for conducting all clinical trials. Practical experience of gaining MHRA and sponsorship approval has yet to be described and critically explored in the literature. Our experience, from start to finish, of applying for these four approvals for a multicentre randomised controlled trial of two licensed drugs for opiate detoxification in the prison setting is described here. In addition, the implications of the approvals process for research projects, particularly clinical trials, in terms of time and funding, and also indirect implications for NHS patients are discussed. Inconsistencies are discussed and suggestions that could improve and streamline the overall process are made. The current approvals process could now be hindering non-commercial clinical trials, leading to a loss of important evidence-based medical information.

Abbreviations: LEEDS, Leeds Evaluation of Efficacy of Detoxification Study; MHRA, Medicines and Healthcare Products Regulatory Agency; MREC, multicentre research ethics committee; NHS, National Health Service; RCT, randomised controlled trial


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati    What's this?

This article has been cited by other articles:

  • Hackshaw, A., Farrant, H., Bulley, S., Seckl, M. J, Ledermann, J. A (2008). Setting up non-commercial clinical trials takes too long in the UK: findings from a prospective study. JRSM 101: 299-304 [Abstract] [Full Text]  
  • Salman, R. A.-S., Brock, T. M, Dennis, M. S, Sandercock, P. A G, White, P. M, Warlow, C. (2007). Research governance impediments to clinical trials: a retrospective survey. JRSM 100: 101-104 [Abstract] [Full Text]  
  • Barbui, C, Cipriani, A (2007). Evidence-based psychopharmacology: an agenda for the future. Evid. Based Ment. Health 10: 4-6 [Full Text]  

eLetters:

Read all eLetters

Ethical review of non-commercial clinical trials
Peter A Heasman
JME Online, 4 Aug 2006 [Full text]
Response to Ethical Review of Non-commercial Clinical Trials
Nat MJ Wright, et al.
JME Online, 25 Aug 2006 [Full text]

This Article

Services
Citing Articles
Google Scholar
PubMed
Topic Collections
Bookmark with

Register for free content

The full back archive is now available for all BMJ Journals. Institutional subscribers may access the entire archive as part of their subscription. Personal subscribers will also have access to all content when logged in. Non-subscribers who register have free access to all articles published before 2006 right back to volume 1 issue 1. Register here to access the free archive of all BMJ Journals.

Don't forget to sign up for content alerts so you keep up to date with all the articles as they are published.