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Are clinical trials units essential for a successful trial?

BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h2823 (Published 27 May 2015) Cite this as: BMJ 2015;350:h2823
  1. M S Gohel , consultant vascular surgeon and honorary senior lecturer, Cambridge University Hospitals and Imperial College London, London, UK,
  2. Ian Chetter , chair of surgery, Hull York Medical School, Hull HU3 2JZ, UK
  1. Correspondence to: M S Gohel m.gohel{at}imperial.ac.uk, I Chetter ian.chetter{at}hey.nhs.uk

Today’s complex studies need the support and expertise that these units bring, writes M S Gohel, but Ian Chetter says they are far from essential

Yes—M S Gohel

The first published randomised trial is credited to Austin Bradford Hill in 1948, for a study funded by the Medical Research Council (MRC) to evaluate the role of streptomycin in patients with tuberculosis.1 The allocation of subjects to treatment arms using sealed envelopes was revolutionary for the era, but clinical trials have come a long way since.

Modern studies are often highly complex, with ever increasing levels of methodological sophistication, near endless regulatory bureaucracy, and stringent quality standards. Clinical trials units (CTUs) are multidisciplinary specialist units that have the specific remit to design, conduct, and report clinical trials. The case for their widespread involvement in all clinical trials is compelling. The 45 units registered by the United Kingdom Clinical Research Collaboration (UKCRC) have shown that they can deliver complex multicentre clinical trials to the highest standards.2 The value of CTUs is recognised internationally, with many established units throughout the United States and Europe. They provide not only methodological expertise but also the logistical support and infrastructure that is essential to deliver a challenging clinical trial.

Support at every stage

Experienced CTUs work with investigators to offer support at every stage of a clinical study, from defining the research question to preparing the final report. In particular, staff are likely to have an excellent practical understanding of relevant legal and regulatory issues, knowledge of necessary approvals needed, and extensive experience of data management and randomisation techniques.

Undoubtedly, many well conducted, high impact clinical studies have been done without CTUs. However, randomised clinical trials in 2015 and beyond are more likely to be large multicentre or multinational studies because these are the only way to achieve the numbers …

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