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Are clinical trials units essential for a successful trial?

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2823 (Published 27 May 2015) Cite this as: BMJ 2015;350:h2823

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Re: Are clinical trials units essential for a successful trial?

Increasing infrastructure and capacity
In order to advance surgical practice we require a strategy that will foster and disseminate high quality surgical research in order to dispel existing attitudes that tolerate high levels of anecdotal evidence, retrospective series and single institution cohort studies to guide patient care. Multicentre studies are more likely to change clinical practice by demonstrating generalisability across a range of cultures and health service structures. Surgeons are increasingly working collaboratively through CTUs to support such high-impact multicentre studies. The Research Division of the Royal College of Surgeons of England has appointed 14 national surgical specialty leads to work with six independently appointed surgical trials centres to strengthen the culture of trials research in UK clinical practice. Their remit is to develop multicentre clinical research including randomised trials and observational studies.

Surgical CTUs can speed innovation
CTU involvement comprises more than just providing isolated access to specific individuals with appropriate skillsets, such as statisticians or methodologists. They deliver a support framework for the longer duration aiding a level of staff development not possible outside of a trials unit. Whilst we expect surgeons to have documented evidence of their ability to perform operations, a CTU with UKCRC registration has equivalent formal evidence of quality and capability, including study design and management to show that they can safely and properly deliver trials. The surgical trials units are also actively engaged in training surgeons in clinical research skills, thereby fostering and strengthening a culture of high quality evaluation of innovation and evidence-based clinical practice. They utilise these networks to speed delivery of trials and surgical innovation, as shown the ROSSINI(1), DREAMS(2), ROCSS(3) and ROMIO(4) trials, all of which have recruited ahead of schedule.

Future of CTUs
Surgical CTUs need to expand over the coming years to accommodate a greater volume of studies, engaging more researchers and patients, whilst maintaining high standards. They are developing ‘open door’ policies, linking surgeons with existing research teams and methodological support. Training more trials managers should support this, with surgeons being embedded within CTUs and in many cases providing clinical leadership to the units.

Birmingham Surgical Trials Consortium: Mr Aneel Bhangu, Dr Laura Magill, Mr Thomas Pinkney, Dr Dmitri Nepogodiev, Mr Simon Bach, Professor Jon Deeks, Professor Pamela Kearns, Professor Dion Morton

Bristol Surgical Trials Centre: Professor Jane Blazeby, Dr Chris Rogers

Surgical Intervention Trials Unit, Oxford: Professor David Beard, Professor Freddie Hamdy

North West Surgical Trials Centre: Professor Nigel Bundred, Professor Paula Ghaneh, Professor John Neoptolemos

National Facial and Oral Research Centre: Professor Peter Sasieni, Professor Iain Hutchison

1. Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D; West Midlands Research Collaborative; ROSSINI Trial Investigators. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial) BMJ. 2013 Jul 31;347.
2. The DREAMS Trial, http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10426
3. The ROCSS Trial http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=13461
4. Avery KN, Metcalfe C, Berrisford R, Barham CP, Donovan JL, Elliott J, Falk SJ, Goldin R, Hanna G, Hollowood AA, Krysztopik R, Noble S, Sanders G, Streets CG, Titcomb DR, Wheatley T, Blazeby JM. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer--the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial. Trials. 2014 Jun 2;15:200

Competing interests: DM is the Director of Surgical Research at the RCS and a director of the Birmingham Surgical Trials Consortium

02 June 2015
Dion G Morton
Professor of Surgery and Director of Surgical Research for the Royal College of Surgeons
On behalf of the Directors of the Surgical Trials Centres of the Royal College of Surgeons
Royal College of Surgeons of England
The Royal College of Surgeons of England, Lincoln's Inn Fields, London WC2A 3PE