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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

Rapid Response:

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

In response to Ian Chetter, we would like to point out that Clinical Trials Research is team science and requires high quality collaboration from a wide variety of experts, not just trial management. Over the last decade the increasing complexity in the regulatory environment and complexity of trial questions as we move for example to personalised medicine or more international collaboration requires a multidisciplinary team response.

Many of these multidisciplinary experts (statistician, data managers, qualitative researchers, clinicians) are found in Clinical Trials Units and the team interaction contributes to the overall quality and robustness of trial findings. The Mazari trial, which did not use a CTU and is noted as successful, suffers from a number of methodological weaknesses; they did not utilise independent randomisation (sealed envelopes were used), do not appear to use intention to treat analysis in the exercise groups, which may have biased the findings in favour of exercise, and they undertook baseline statistical testing. Many CTUs incorporate qualitative research within their trials and this has been shown to successfully address patient barriers to participation (Donovan). Most CTUs actively engage, train and coordinate patient representation at every stage of the trial process.

Collaboration with a CTU provides security and stability in trial management as opposed to reliance on a single trial manager. The CTU environment is ideally suited to training trial managers, providing professional and career development. It also ensures that they have direct and immediate access to a wide range of expertise required to successfully execute a trial including quality assurance, programmers, statisticians and regulatory advice. The UKCRC Registration System for CTUs ensures that CTUs have the required expert multidisciplinary team, robust quality assurance and data management systems, and appropriate regulatory systems and can provide security and stability for trials in unforeseen circumstances. This robustness and assurance is not in place for standalone trials and can lead to poor quality which is both unethical and a waste of money. Clearly you do have to pay an adequate amount to ensure quality. Commercial trials may not use CTUs but this is arguably due to their business needs rather than costs as they do utilise commercial contract research organisations, which are likely to be more expensive.

Finally rather than being divorced from clinical communities UKCRC Registered CTUs are required to demonstrate that they have senior clinical input at a strategic level and around 50% of them have Clinical Directors of the Unit.

Donovan et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002 Oct 5; 325(7367): 766–770.

Competing interests: I am the Director of the UKCRC Registered CTU Network and Director of the Leeds Clinical Trials Research Unit

29 May 2015
Julia M Brown
Director of the UKCRC Registered CTU Network
On behalf of the UKCRC Registered CTU Network
University of Leeds
Leeds Institute of Clinical Trials Research, Univeristy of Leeds, Leeds LS2 9JT