ReviewJournal of medical ethics2006
Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?
Review in Journal of medical ethics, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparison of methadone and buprenorphine for opiate detoxification (LEEDS trial): a randomised controlled trial.The British journal of general practice : the journal of the Royal College of General Practitioners · 2011Pooled it
- Setting up a clinical trial for a novel disease: a case study of the Doxycycline for the Treatment of Nodding Syndrome Trial - challenges, enablers and lessons learned.Global health action · 2018Trial
- Trial
- The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) prisons project: a randomised controlled trial comparing dihydrocodeine and buprenorphine for opiate detoxification.Substance abuse treatment, prevention, and policy · 2009Trial
- Institutional Scientific Review of Cancer Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines.Journal of oncology practice · 2017Article
- Impact of NCI-mandated scientific review on protocol development and content.Journal of the National Comprehensive Cancer Network : JNCCN · 2015Article
- The advance of research governance in psychiatry: one step forward, two steps back.Epidemiology and psychiatric sciences · 2013Article
- Bureaucracy stifles medical research in Britain: a tale of three trials.BMC medical research methodology · 2012Article
- How the NHS research governance procedures could be modified to greatly strengthen clinical research.Clinical medicine (London, England) · 2010Article
- Regulation and the social licence for medical research.Medicine, health care, and philosophy · 2008Article
- Setting up non-commercial clinical trials takes too long in the UK: findings from a prospective study.Journal of the Royal Society of Medicine · 2008Article
- Research governance impediments to clinical trials: a retrospective survey.Journal of the Royal Society of Medicine · 2007Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.