2023 was an exciting time for the UKCRC Registered CTU Network with changes in the research environment and opportunities to build on learning from the pandemic and transform the design and delivery of trials. There were also changes within the Network Secretariat.
In the spring, Prof Julia Brown announced that she had taken the difficult decision to stand down as Network Director. She was instrumental in the development of the Network and had led it from its inception. We are very grateful for her leadership over the previous 16 years.
Fortunately, we were able to recruit an excellent replacement in Prof Kerry Hood. Kerry is currently Dean of Research & Innovation for the College of Biomedical & Life Sciences at Cardiff University and has played a vital role with the Network since 2007, firstly as Director of the South East Wales Trials Unit and then the Centre for Trials Research.
Our various Operations and Task & Finish Groups met 60 times during the year to work on activities that are of benefit to CTUs and CTU staff across the Network. This included producing guidance, webinars, training events and, of course, the 8 national meetings we held for key staff groups including CTU Directors, statisticians, and trial monitors.
During the year, over 750 delegates from across the Network took part in face-to-face or online events. These included webinars on subjects as diverse as the Better Methods, Better Research funding programme and different approaches to data management. There were also quarterly ‘monitoring clinics’ which provided an opportunity for staff with a responsibility for trial monitoring to share experiences, solutions, and best practice.
There were more than 2000 views and downloads of our guidance and training materials. These include the training for staff undertaking clinical trial monitoring, as well as information to support units preparing to undergo MHRA inspection. All outputs can be viewed here.
The UKCRC Registered CTU Network’s PeRSEVERE Project team has launched a dedicated website bringing together all its guidance on managing participation changes in clinical trials.
PeRSEVERE focused on participants in clinical trials stopping, reducing or changing their level of involvement.
The project aimed to address the question: how should we design and carry out clinical trials and other research, given that we know some participants will stop participating early?
PeRSEVERE was a collaborative effort, involving representatives of many different clinical trials units and different areas of expertise from across the CTU Network, as well as a patient group.
The team developed high-level principles to guide management of early end of participation in clinical trials and other research studies. Between May and August 2021, they ran a public consultation on the draft principles. The responses to the consultation were used to agree the final principles and associated explanatory guidance.
We are delighted to announce that Prof Kerenza (Kerry) Hood will take up the role of Director of the UKCRC Registered CTU Network on 1st October. Her appointment follows a competitive process that started in May this year and was overseen by the Chair of the Executive Group, Simon Denegri OBE
Kerry Hood is currently Dean of Research & Innovation for the College of Biomedical & Life Sciences at Cardiff University and has played a vital role with the UK network since its inception in 2007, firstly as Director of the South East Wales Trials Unit and then the Centre for Trials Research.
Kerry’s research has centred on the conduct of complex clinical trials, mainly focusing on primary care, infections and learning disabilities.
Her leadership has been critical to the development of clinical trials in Wales and she has also been co-leading the Trial Conduct Working Group of the Trial Methodology Research Partnership for the last five years.
On her new role Kerry said:
“I’m excited by the opportunity to work with all of our brilliant CTU’s to move the network forward. We are seeing major changes in the way in which trials are designed and run and this is being led by our members, building on a set of standards and values which focus on quality, impact and public and patient involvement. It is an honour and a privilege to take the baton from Julia and build on the incredible network she has developed.”
Commenting on her appointment, Simon Denegri OBE (Executive Group Chair) said:
“On behalf of the UKCRC CTU Network members I would like to warmly welcome Kerry Hood to the role of Director of the Network. Kerry has an outstanding track record and reputation in clinical trials and clinical research and is passionate about the important role of the Network in driving innovation in clinical trials while maintaining the highest standards of quality for which the UK has become known. It says everything about the standing of the Network that we have been able to attract someone of Kerry’s calibre. As Chair of the Network Executive Group, I look forward to working with Kerry and our members to put the work of Clinical Trials Units at the forefront of all that is good about UK clinical research.”
The Network would like to extend its thanks to the outgoing Director Julia Brown. Simon Denegri said:
“Julia’s leadership has been fundamental to the successful growth and influence of the Network over the last 15 years, and we would like to take this opportunity to thank her on behalf of the Network. Julia leaves a strong legacy for Kerry and the Network to build on.”
About Kerry Hood
Kerry is a Professor of Trials and Dean of Research & Innovation for the College of Biomedical & Life Sciences at Cardiff University. She is a Senior Research Leader and mentor for Health & Care Research Wales.
She has a degree and PhD in Statistics and spent the first part of her career focussed on research in primary care and then in 2006 established the South East Wales Trials Unit and started to develop a broader research portfolio. In 2015 she was appointed to lead the merger of three CTUs at Cardiff and created the Centre for Trial Research and was the Director until 2023.
She is a Fellow and Chartered Statistician of the Royal Statistical Society and the Higher Education Academy and a member of the Society for Academic Primary Care and the British Society for Antimicrobial Chemotherapy.
About the Network
The UKCRC Registered CTU Network is a network of 51 Clinical Trials Units that have been assessed against key criteria by an independent international panel of experts in clinical trials research. Registration acts as a hallmark of quality, excellence and integrity and provides assurance to the standard of studies undertaken by Registered units. Our vision is for Registered Clinical Trials Units to be recognised as world leaders in the design and delivery of high-quality, effective, efficient, and sustainable clinical trials research. Through the creation of working groups, forums, and learning opportunities for member CTUs and their staff, and by engaging with key stakeholders including regulators and funders, we aim to: Develop and share best practice across our members: Improve the promotion of Registered Clinical Trials Units and to be a strong voice for Registered Clinical Trials Units
Recent discussions amongst statisticians from Registered CTUs seem to indicate that there is a gap in training and development opportunities for statisticians looking to move into senior roles within academic clinical research. This piece explores some of the common practices across the Network and discusses what else could be done.
At the Spring 2023 Statistics National Meeting delegates heard about a project being undertaken by the ICR-CTSU to identify training opportunities for trial statisticians at all stages of their careers. As part of the session, Fay Cafferty (The ICR-CTSU) noted that although learning and development for early career statisticians was generally well provided for, finding options for those looking to move into more senior roles was more challenging.
Delegates at the meeting, who were drawn from units across the UK and who were at varying stages of their career, then had the opportunity to share their personal experiences and discuss the practices at their unit.
As expected, there was a range of approaches in the provision of learning and development opportunities. Some units had formal training in place for new starters, either individually or in teams, others provided more informal on-the-job training by experience. Generally, training was better developed for more junior staff.
Shadowing and mentoring
Documented shadowing or working in parallel with more senior colleagues as part of training was discussed, though this depended on there being sufficient time available for both parties. Given typical hybrid working arrangements, it was recommended that agreeing core or overlapping days could facilitate shadowing more effectively. Some commented that it was more difficult to seek help when working remotely. Others suggested that, in large units, it could be difficult for junior colleagues to know where various types of expertise sat. Mentoring from a senior statistician at another CTU could be beneficial, allowing more open discussion and guidance on career development.
Postgraduate study
Various units allowed day-release for junior staff to undertake an MSc (in person or at distance) or support fellowships e.g. at pre-doctoral level, some had a requirement for their staff to hold a PhD in order to progress; others allowed progression based on having accrued several years’ experience working in trials. A few units supported candidates working towards a PhD-by-publication. At least two Units recruited to ‘trainee statistician’ roles. Progression to a more senior role was often via a postdoctoral research fellowship. Many units liked to grow their own statisticians from postgraduate study all the way through to becoming experienced trial statisticians. Noting that it can often be very difficult to recruit more experienced statisticians externally.
Skills development
A good learning opportunity for junior colleagues could be to validate methods used e.g., a more junior statistician tries replicating a sample size calculation that was performed by a more senior colleague. Aside from learning methods and trial processes, it was regarded as important for staff to develop their soft skills, e.g. by attending generic courses provided by the host institution on writing, leadership, and communication skills. Teaching was highlighted as an excellent way to develop communication skills. Further, those working in applied research could benefit from reading up on relevant clinical areas to increase understanding and facilitate communication with investigators. Observing a funding panel meeting was suggested as a good development opportunity. The use of checklists for on-the-job training, or a handbook, was found to be useful by some.
Training resources
Several units had training presentations available or encouraged staff to attend free webinars. Training materials produced during the pandemic were cited as a good resource for staff. Others suggested that, as a Network, we could share such resources between us e.g. recording a training session and then making the recording available to Network colleagues. It was suggested that it would be worth exploring costing training activities into grant applications. In general, it was thought important that all statisticians in a Unit should have access to the same training opportunities. One person commented on potential inequality of training opportunity between jobbing statisticians and personnel on fellowships. Network resources for training include GCP for Statisticians (in development) and guidance on the validation of statistical programming.
Career progression
In one unit, career progression was contingent on being a co-applicant on at least one successful grant application. In terms of grant applications, a junior statistician might work with a more senior colleague on an application, with both going on as co-applicants. Setting up knowledge sharing or working groups was also suggested. It was agreed that it would be worthwhile to lobby funders for more money for methodological support. Concerns were voiced about the loss of core NIHR funding for CTUs, potentially reducing funds available for training and development.
What next?
The Statistics Operations Group are considering developing a forum for units to share internally created training and development materials and/or signpost to external options. They are particularly keen to identify resources for those looking to move on to a more senior role.
If you would be willing to share resources with colleagues at other Network CTUs please contact the Secretariat (regctus@leeds.ac.uk).
The 2023 annual update process has now opened for all fully and provisionally registered Clinical Trials Units (CTUs).
To become a UKCRC Registered CTU, UK-based non-commercial research units are required to demonstrate excellence in a number of critical areas relating to their ability to design, deliver, and analyse high-quality clinical trials.
The update process allows CTUs to demonstrate how they have evolved over the preceding 12 months, as well as ensuring that the high standards required by registration are maintained.
We look forward to hearing from our registered units over the next few months.
A call for new applicants is also currently open. Find out more here.
The UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Units (CTU) Network invites previously unregistered academic Clinical Trials Units to submit applications as part of the 2023 Open Call.
The registration process is designed to help improve the quality of available expertise to carry out clinical trials in the UK. Leading the review is a Committee of internationally recognised experts in clinical trials.
CTUs are specialist units that bring together the expertise needed to undertake a clinical trial or other well-designed studies. Running a study is a complex process and Registered Units need to have the expertise to design, coordinate and analyse them, whilst ensuring that they are conducted in line with appropriate standards and regulations.
To be eligible to apply, units must demonstrate that they are capable of centrally coordinating multi-centre clinical trials and other well designed studies with responsibilities related to the design, conduct, data management, publicity, analysis and reporting of a study.
The deadline for applications is 12 noon on 6 November 2023.
You can find out more on the eligibility criteria and registration process here. For answers to common queries please visit our FAQ page or contact the Secretariat on regctus@leeds.ac.uk.
In autumn 2022, Munya Dimairo from Sheffield CTU secured a prestigious award at the International Clinical Trials Methodology Conference (ICTMC) in Harrogate for his remarkable presentation titled “A Practical Adaptive Designs Toolkit: Making adaptive designs more accessible” (PANDA).
Among numerous contenders, his work truly shone in the eyes of the CTU Directors, who sought out the session with the “greatest potential for future impact.” We commend his expertise and unwavering commitment to advancing clinical trials methodologies.
We took a moment to chat with him about his project and what has changed in the 12 months since he won his award. Here’s what he had to share:
What has changed for you since receiving the award?
Being acknowledged on behalf of the PANDA team was an incredible moment. Our creation of an open-access, self-paced educational resource has sparked significant interest. Post the ICTMC 2022, we observed a surge in engagement with the PANDA resource, evident through increased Google Analytics activity. The positive feedback from platform users has been gratifying. Moreover, I’ve been honoured with invitations to conduct outreach training sessions, both in-person and through webinars. These sessions focus on guiding users in utilizing the PANDA platform to devise trial designs and navigate practical intricacies.
What do you hope will come from receiving this award and what will hopefully come from your piece of work?
Our aspiration is to foster broader involvement from the research community across sectors, ensuring continual enhancement of the PANDA resource’s longevity. The PANDA resource stands to enrich the multidisciplinary research landscape, equipping stakeholders with practical insights into randomised adaptive trials’ design, execution, analysis, and reporting. This, in turn, aims to bolster the adoption of efficient adaptive designs, ultimately benefiting patients and the public. Our vision is for PANDA to evolve into a comprehensive educational repository on adaptive trials, a user-friendly conduit for diverse stakeholders to empower themselves in adaptive design methodologies.
What’s next for you? Are there any more current pieces of work that you’re currently a part of that you’d like to share?
The journey for PANDA continues with a focus on ongoing refinement. Collaboratively, I’m engaged with fellow researchers, including colleagues from the MRC-NIHR TMRP Adaptive Designs Working Group. Our efforts extend to diverse methodological projects, contributing directly or indirectly to enhancing PANDA’s impact. These encompass aspects such as estimating treatment effects post adaptive trials, crafting guidance for participant information sheets, formulating estimands, drafting statistical analysis plans, elucidating sample sizes in grant proposals, devising robust interim analysis protocols, and extending SPIRIT and CONSORT guidelines to early phase dose-finding trials. Our commitment remains resolute in driving meaningful progress in clinical trial methodologies.
With Munya’s pioneering work, we glimpse a future where clinical trials stand as beacons of innovation, empowering both researchers and the public alike.
The Network is now able to announce that we are opening a call for applications for the post of Director of the UKCRC Registered CTU Network. As the collective voice of clinical trials units the Network plays an important role in engaging with Government, funders, other agencies and patients to improve and strengthen clinical research in the UK. The Network is seen internationally as an exemplar for the development of national clinical trials support.
The Director appointment is made on a paid secondment basis. Please see the candidate brief for further details [Download candidate brief].
Interested candidates are asked to submit an up-to-date short CV plus covering letter (500 words) outlining their vision for the Network, how they would evolve its activities and how they believe they fulfil the role description by Monday 19th June 2023.
The Network had a fantastically busy 2022. Find out more about our activities through some of our favourite facts and figures!
We got a new Clinical Director, the wonderful Rustam Al-Shahi Salman. Although his appointment was formally announced in January 2023, he worked with us in 2022 to help design his role. Find out more here.
We held a showcase session entitled “Better Trials Together at the 6th International Clinical Trials Methodology Conference (ICTMC) in Harrogate in October 2022, which focussed on how working together continued to impact and enhance the clinical trials landscape. We also had a stand in the main exhibition space. There was input from Network CTUs in over 50% of the pre- and post-conference workshops, as well as more than 80% of the parallel sessions. For the first time we also sponsored an award to recognise the presentation that CTU Directors though had the “greatest potential for future impact”. We had an absolutely fabulous time; we’re already planning for the next ICTMC in Edinburgh in 2024. We hope to see you there! Find out more about the ICTMC here.
We attended not one but two careers events run by Statisticians in the Pharmaceutical Industry (PSI). This enabled early career statisticians from Network CTUs to speak to undergraduate and MSc students about what life is like in an academic clinical trials unit. Find out more about PSI careers events here.
We ran seven webinars and training sessions, including four Massive Open Online Courses (MOOCs) on different aspects of clinical trial monitoring. These can be viewed for free via our website. You can also get a copy of the accompanying handbook from the same page. This has now been downloaded over 4,400 times. You can view and download these and other materials here.
Our various Operations and Task & Finish Groups met 70 times during the year to work on activities that are of benefit to CTUs and CTU staff across the Network. This included producing guidance, webinars, training events and, of course, the 8 national meetings we held for key staff groups including CTU Directors, statisticians, and trial monitors. We’re very pleased to say that three of them took place face-to-face. Find out more about the Network andour groups here.
2023 is already shaping up to be another exciting year and we look forward to announcing lots of events, activities, and guidance documents as the days and weeks go by. Follow us on LinkedIn or Twitter (@UKCTUNetwork) for more updates.
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