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

Journal of Medical Ethics

Volumn 32, Issue 7, 2006, Pages 430-434

  Sheard, Laura ^a,d   Tompkins, C N E ^a   Wright, N M J ^b   Adams, C E ^c  

^a East Leeds Primary Care Trust   (United Kingdom)

^b HMP Leeds   (United Kingdom)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d Centre for Research in Primary Care   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BUPRENORPHINE; LOFEXIDINE; METHADONE; OPIATE; PLANT MEDICINAL PRODUCT;

ARTICLE; CLINICAL TRIAL; DRUG APPROVAL; DRUG DETOXIFICATION; EVIDENCE BASED PRACTICE; FUNDING; HUMAN; MEDICAL INFORMATION; NATIONAL HEALTH SERVICE; PRISON; RESEARCH ETHICS; TIME; UNITED KINGDOM;

ANALGESICS, OPIOID; BUPRENORPHINE; DRUG APPROVAL; ETHICS, RESEARCH; GREAT BRITAIN; HUMANS; METHADONE; MULTICENTER STUDIES; PRISONS; RANDOMIZED CONTROLLED TRIALS; STATE MEDICINE;

EID: 33746076734     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2005.015180     Document Type: Article

References (35)

1. Department of Health. Research governance framework or health and social care. London: Department of Health, 2001, http://www.dh.gov.uk (accessed 7 Sep 2005).
2. Department of Health. Research governance framework for health and social care, 2nd edn. London: Department of Health, 2005, http://www.dh.gov.uk (accessed 7 Sep 2005).
3. The Royal Liverpool Children's Enquiry. The report of the Royal Liverpool Children's Enquiry. Liverpool: The Royal Liverpool Children's Enquiry, 2001, http://www.rlcinquiry.org.uk/ (accessed 7 Sep 2005).
4. Boshier A, Shakir S, Telfer P, et al. The negative effect of red tape on research. Pharmacoepidemiol Drug Saf 2005;14:373-6.
5. Dumville J, Watson J, Raynor P, et al. Research governance: a barrier to ethical research? Q J Med 2004;97:113-4.
6. Salisbury C, Leese B, McManus R. Ensuring that research governance supports rather than stifles research. Br J Gen Pract 2005;55:4-5.
7. Leese B, Burt J. Research governance in primary care trusts in England: making multi-centre studies even more difficult? Primary Health Care Res Dev 2005;6:93-4.
8. Wald S. Bureaucracy of ethics applications. BMJ 2004;329:282-4.
9. Glasziou P, Chalmers I. Ethics review roulette: what can we learn? BMJ 2004;328:121-2.
10. Department of Health. Report of the ad hoc advisory group on the operation of NHS research ethics committees. London: Department of Health, 2005, www.dh.gov.uk (accessed 23 Aug 2005).
11. Central Office for Research Ethics Committees. London, 2005 http://www.corec.org.uk (accessed 12 Sep 2005).
12. Hannigan B, Allen D. A tale of two studies: research governance issues arising from two ethnographic investigations into the organisation of health and social care. Int J Nurs Stud 2003;40:685-95.
13. Howarth M, Kneafsey R. The impact of research governance in healthcare and higher education organizations. J Adv Nurs 2005;49:675-83.
14. Directive 2001/20/EC of the European Parliament and of the Council 2001. http://eudract.emea.eu.int/docs/Dir2001-20_en.pdf (accessed 7 Sep 2005).
15. Rice M. Directive threatens clinical research in Europe. BMJ 2004;96:984.
16. Ray E, O'Brien T. A red light for a blue light. Br J Urol 2005;96:747-8.
17. Hall J, Diaz-Navarro C. Living with the European Clinical Trials Directive: one year on. Anaesthesia 2005;60:949-51.
18. Woods K. Implementing the European Clinical Trials Directive. BMJ 2004;328:240-1.
19. Kerrison S, McNally N, Pollock A. United Kingdom research governance strategy. BMJ 2003;327:553-6.
20. Oldham N, Wright N, Adams C, et al. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project: an open label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for primary care detoxification from either street heroin or methadone. BMC Fam Pract 2004;5:9.
21. National Treatment Agency. Models of care: for adult drug misusers. London: Department of Health, 2002.
22. Howells C, Allen S, Gupta J, et al. Prison based detoxification for opioid dependence: a randomised double blind controlled trial of lofexidine and methadone. Drug Alcohol Dependence 2002;67:169-76.
23. Declaration of Helsinki. http://www.wma.net/e/policy/b3.htm (accessed 13 February 2006).
24. Amato L, Davoli M, Minozzi S, et al. Methadone at tapered doses for the management of opioid withdrawal. Cochrane Database Syst Rev 2005;(3): CD003409, http://www.mrw.interscience.wiley.com/cochrane/clsysrev/ articles/CD003409/frame.html (accessed 26 Oct 2005).
25. Gowing L, Ali R, White J. Buprenorphine for the management of opioid withdrawal. Cochrane Database Syst Rev 2004;(4): CD002025, http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/ CD002025/frame.html (accessed 26 October 2005).
26. European Clinical Trials Database. https://eudract.emea.eu.int/eudract/index.do, (accessed 11 Mar 2005).
27. International Committee of Medical Journal Editors. 2005. http://www.icmje.org (accessed 18 Oct 2005).
28. Abbasi K. Compulsory registration of clinical trials. BMJ 2004;329:637-8.
29. Blunt J, Savulescu J, Watson A. Meeting the challenges facing research ethics committees: some practical suggestions. BMJ 1998;316:58-61.
30. Elwyn G, Seagrove A, Thorne K, et al. Ethics and research governance in a multi centre study: add 150 days to your study protocol. BMJ 2005;330:847.
31. Mayor S. Squeezing academic research into a commercial straitjacket. BMJ 2004;328:1036.
32. Jamrozik K. Research ethics paperwork: what is the plot we seem to have lost? BMJ 2004;329:286-7.
33. National Cancer Research Network. http://www.ncrn.org.uk/ (accessed 2 Nov 2005).
34. Mental Health Research Network. http://www.mhrn.info/ (accessed 2 Nov 2005).
35. Prison Health Research Network. http://www.phrn.nhs.uk (accessed 2 Nov 2005).