ArticleBMJ open2014
Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays.
Article in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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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
13 citing papers in PubMed, 24 citations in OpenAlex.
- A pilot randomised controlled trial of befriending by volunteers in people with intellectual disability and depressive symptoms.Journal of intellectual disability research : JIDR · 2021Trial
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- Challenges of a community based pragmatic, randomised controlled trial of weight loss maintenance.BMC research notes · 2015Trial
- The overlap between randomised evaluations of recruitment and retention interventions: An updated review of recruitment (Online Resource for Recruitment in Clinical triAls) and retention (Online Resource for Retention in Clinical triAls) literature.Clinical trials (London, England) · 2024Review
- Commentary: The North West London Clinical Trials Alliance: efficiency and innovation in clinical trial delivery.Trials · 2024Article
- Non-COVID-19 UK clinical trials and the COVID-19 pandemic: impact, challenges and possible solutions.Trials · 2023Article
- Regulatory delays in a multinational clinical stroke trial.European stroke journal · 2021Article
- Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial.Trials · 2019Article
- Creating a pragmatic trials program for breast cancer patients: Rethinking Clinical Trials (REaCT).Breast cancer research and treatment · 2019Review
- Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.BMC medical ethics · 2019Article
- Article
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Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo investigate the length of time taken to open UK research sites in multicentre clinical trials and to identify reasons for any delays.
designA case study, recording key milestone dates from the time a site receives ethical approval through to opening to recruitment. Delay reasons were prospectively logged by trial staff at a minimum of fortnightly periods using a coding system.
settingSANADII, a phase IV pragmatic trial, managed by the Clinical Trials Research Centre, Liverpool. The trial seeks to work with over 100 National Health Service (NHS) sites to meet its recruitment target of 1510 patients. OUTCOMES AND ANALYSIS: The primary outcome was time from Multicentre Regional Ethics Committee (MREC) approval to site opening using survival analysis. Where sites took over a specified time to reach milestones (>3 months from MREC to Site Specific Information (SSI) submission, >30 days from SSI validation to local R&D approval, or >30 days from local Research and Development (R&D) approval to opening to recruitment), the longest continuous delay during that milestone was identified.
resultsThe median opening time for participating sites was 9.7 months (IQR 6.2 to Not Reached). SSI submission took 7 months (IQR 4.1-12.3) from ethics approval, R&D approval took 16 days (IQR 5.0-32.0) from SSI validation and site opening took 15 days (IQR 8.5-40.0) following R&D approval. The longest delays before SSI submission resulted from negotiating excess treatment costs, finalising logistics, collecting CVs and ongoing participation discussions.
conclusionsWhile recently imposed targets are reducing the time taken for R&D departments to approve valid applications, the time taken to open UK research sites remains excessive and must be reduced. At present significant public funds are being used inefficiently in order to navigate NHS systems, challenging the resolve of trial teams and the competitiveness of the UK.
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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.