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

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Bibliographic Details
Published in:Journal of medical ethics 2006-07, Vol.32 (7), p.430-434
Main Authors: Sheard, L, Tompkins, C N E, Wright, N M J, Adams, C E
Format: Article
Language:English
Subjects:
Analgesics, Opioid - therapeutic use
Analysis
Bioethics
Buprenorphine - therapeutic use
Clinical trials
Committees
Drug Approval - methods
Drug withdrawal
Drugs
Ethics committees
Ethics, Research
Funding
Governance
Health care industry
Humans
LEEDS
Leeds Evaluation of Efficacy of Detoxification Study
Medical research
Medicines and Healthcare Products Regulatory Agency
Methadone
Methadone - therapeutic use
MHRA
MREC
Multicenter Studies as Topic - ethics
multicentre research ethics committee
Narcotics
National Health Service
NHS
Opiates
Patient safety
Prisoners
Prisons
R&D
randomised controlled trial
Randomized Controlled Trials as Topic - ethics
RCT
Research & development
Research Ethics
Services
State Medicine
United Kingdom
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Description
Summary: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.
ISSN:0306-6800
1473-4257
DOI:10.1136/jme.2005.015180