Annual Registration Update Opens

Annual Registration Update Opens

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.

Open Call for Registration

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.

Celebrating Excellence in Clinical Trials!

Munya Dimairo (centre) collecting his award from Julia Brown (left).  Shown with Macey Murray (right)

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.

If you like to find out more about Munya and the PANDA Project visit https://panda.shef.ac.uk/.

NIHR Research Support Service (RSS) Announcement

The UKCRC Registered Clinical Trials Unit (CTU) Network welcomes the NIHR RSS announcement and looks forward to working collaboratively in the future.

Some registered CTUs will be part of NIHR RSS, and some will not. All CTUs offer the following:

  • collaboration throughout the whole lifecycle of a trial from grant application through to analysis and dissemination.
  • specialist clinical trials expertise.
  • breadth and depth of knowledge including trial management, data management, regulatory and statistical support.
  • UK wide availability.
  • assured high quality collaboration, internationally peer reviewed.
  • higher likelihood of delivery to time and target.

For more information on the work of the UKCRC Registered CTU Network and member CTUs please visit https://ukcrc-ctu.org.uk/about-us/.

Further details on the remit of the Research Support Service can be found on the NIHR’s website.

Call for a new Director of the UKCRC Registered Clinical Trials Unit (CTU) Network

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’s 2022 in numbers

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 and our 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.

Career Opportunities in Academic Clinical Trials Unit

If you are interested in science, improving patient choices & treatments, and enjoy working as part of a team, there are many options within academic clinical trials.

In collaboration with the UK Trial Managers Network, we have published an e-flyer to highlight the role of Clinical Trials Units and the types of jobs on offer within them.

The flyer looks at five key areas: Trial Management, Quality Assurance, Information Systems, Statistics, and Data Management, and outlines some of the core activities and skills for each one.

Download your copy to find out more.

New Clinical Director joins UKCRC Registered CTU Network

We are exceptionally pleased to announce that Prof Rustam Al-Shahi Salman has accepted the offer of a part-time secondment to the UKCRC CTU Network as Clinical Director, after an open application process in 2022.

Rustam is a chair of clinical neurology at The University of Edinburgh, practising honorary consultant neurologist in NHS Lothian, as well as clinical director of the Edinburgh CTU.

He leads the Research to Understand Stroke due to Haemorrhage (RUSH) programme, which is dedicated to improving the outcome for adults who have diseases that may cause, or have caused, stroke due to intracranial haemorrhage.

He also has an interest in increasing the value of biomedical research by minimising waste in the choice of research question, study design, study conduct, regulation, and reporting.  This led to him becoming one of the lead authors of The Lancet’s 2014 Series on Increasing Value and Reducing Waste in Research (www.thelancet.com/series/research) and the related campaign (www.thelancet.com/campaigns/efficiency).

Drawing on his experiences as both a clinician and a clinical trial chief investigator, he will define the scale and scope of what better relationships between clinical trials units and clinical communities look like, plan and carry out some activities to improve this relationship, and what metrics could be used for light touch evaluation of this activity across the UK.

We very much look forward to working with him over the next two years.

Raising the profile of data management

The collection and management of robust, reliable, and statistically sound data has long been recognised as a vitally important part of a successful clinical trial and a core activity within a well-functioning clinical trials unit (CTU).

In CTUs, data managers usually work closely with IS teams, or are embedded within them. For that reason, data management has always been within the remit of the IS Operations Group. However, it deserves further attention as a activity in its own right.

In order to raise the profile of this important part of the Groups remit, a number of changes have been made. Firstly, a permanent working group has been established to take data management activities are taken forward. Four workstreams have been identified and the teams will begin meeting this year. The workstreams are:

  1. CRF/eCRF Development
  2. Data validation and query process
  3. Study database lifecycle
  4. Working with external/third party data sets

Secondly, the name of the Group has been changed to Data and Information Systems Operations Group (DaIS for short).

We look forward to sharing updates on the work of the four data management workstreams, as well other DaIS outputs, throughout the year.

Find out more about the Network and its mission here. You can also follow on us on LinkedIn and Twitter.

6th International Clinical Trials Methodology Conference – October 2022

The UKCRC Registered CTU Network are excited to be part of the 6th International Clinical Trials Methodology Conference in Harrogate.

Running from the 3 – 6 October 2022, ICTMC is the leading international platform for researchers and practitioners to present the very latest in trials methodology research. The meeting also offers valuable networking and training opportunities, with over 750 delegates from 22 countries attending in 2019.

As well as a stand in the exhibition hall, the Network has a showcase session “Better Trials Together” (Wednesday 5 October 2022 at 14:00), with sessions on how working together continues to impact and enhance the clinical trials landscape.  Presentations include lessons from the PANORAMIC Trial, an update from an ongoing project to reduce carbon use in clinical trials, and a look at current and future challenges for CTUs, and clinical research more broadly.

Registered CTUs are also featured in most of the parallel sessions and have dozens of posters on view.

Find out more about the conference here.

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