Marking the Second Year of our Commitment to Environmental Sustainability in Research

Marking the Second Year of our Commitment to Environmental Sustainability in Research

As we approach World Environment Day on 5 June, this year’s focus on urgent action on climate change feels particularly timely. The record-breaking heatwave seen across the UK in May 2026 has brought the reality of climate impacts into sharp relief, underlining the importance of acting now.

Against this backdrop, we’re proud to mark two years as a Supporter of the Concordat for the Environmental Sustainability of Research & Innovation Practice. This milestone is an opportunity to reflect on the progress made so far, and to look ahead at how we continue to embed sustainability across the clinical trials landscape.

By signing the Concordat, we committed to action across three priority areas: leadership and system change, emissions from academic travel, and collaborations and partnerships.  We also agreed to provide annual updates of our progress.  You can find out more below.

Leadership and system change

We recognise that high-quality, impactful research must also be sustainable.

The Network’s Strategy for 2025 – 2030, which was published in June 2026, included a strong commitment to encouraging, supporting, and disseminating sustainable research practices both internally and across our members CTUs.

Since then, we have been working to embed these ambitions into our practice.  This includes the creation of a Sustainability Group which is looking at both environmental sustainability and the broader sustainability of Clinical Trials Units.

Sustainability has also been a recurring theme at several of our national meetings. This includes the CTU Directors’ Meeting in May 2026, which brought together senior leaders from across the Network alongside wider stakeholders to explore key developments in clinical research, including the UKRI’s SPARKHub platform and a dedicated roundtable of CTU leaders on environmental sustainability in clinical trials

Reducing emissions from academic travel

We have continued to build on earlier changes to reduce travel-related emissions. Face-to-face meetings are now fewer and more purposeful, with digital materials provided as standard. Where possible, meetings are combined to minimise journeys, and we have transitioned to lower carbon alternatives for catering.

Our online programme continues to expand, with webinars, roundtables, and specialist clinics providing accessible opportunities to connect and share knowledge. Over the past 12 months, this has included 10 roundtables, 9 clinics, 9 webinars, and 6 user group meetings, bringing together over 1,700 participants without the need for additional travel (up from 1,200 the year before).

This approach is not only reducing environmental impact but also improving accessibility and inclusion across the Network.

Collaborations and partnerships

Working collaboratively remains central to how we drive sustainable change. By sharing knowledge and approaches, Registered CTUs can improve existing processes while also exploring new, more efficient ways of working.

In addition to our sustainability group, other Network groups are exploring how digital tools (including AI) can be used more effectively, as well as how remote alternatives can be built into routine practice.

We also continue to contribute to wider initiatives, including the development, piloting, and dissemination of a carbon footprinting tool for clinical trials with the TMRP Greener Trials Group.

Additional guidance on undertaking greener trial monitoring, with real-world examples drawn from across the Registered CTU Network, has recently been approved and will be shared in the next few weeks

Together, these efforts help reduce duplication, save resources, and support more sustainable research delivery.

Looking ahead

As we enter our third year as a Concordat Supporter, our focus remains on building momentum; working together to make meaningful, lasting improvements in how clinical research is designed and delivered.

Together we can make a difference.

Find out more

~ To learn more about the aims and ambitions of the Concordat click here.
~ To download the Network’s official letter of support from 2024 please click here.
~ You can find out more about World Environment Day, and this year’s focus on urgent climate action, here.

Diabetes Awareness Week 2026: Let’s Change How We Talk About Diabetes

8 – 14 June 2026 is Diabetes Awareness Week.  This year’s focus is on tackling some of the negative attitudes that those living with diabetes still encounter

Diabetes UK estimates that almost 6 million people in the UK are living with diabetes. This figure includes more than one million people who are believed to be living with undiagnosed type 2 diabetes. As cases continue to rise, experts are calling not only for better prevention and treatment strategies, but also for a shift in how society understands and talks about the condition.

Diabetes is a complex and often misunderstood health condition. While it is commonly associated with lifestyle factors, the reality is far more nuanced. Oversimplifying what it means to live with diabetes, and why it develops, can contribute to harmful stigma. 

This stigma remains a major challenge for people living with diabetes. Research from Diabetes UK indicates that eight in ten individuals with the condition have experienced negative attitudes, from judgemental comments to harmful stereotypes. Many report being blamed for their diagnosis or subjected to sweeping generalisations about their health and lifestyle.

Healthcare professionals warn that this can have serious consequences, including missed appointments and delayed treatment, ultimately affecting long-term health outcomes.

As part of these awareness efforts we are highlighting progress in diabetes research.

Below you can read about 4 very different trials conducted by Registered Clinical Trials Units (CTUs) that aim to advance treatment and quality of life for people living with diabetes.


Improving Diabetes Self-Management in Adults with Intellectual Disabilities: My Diabetes & Me

An increasing life expectancy in people with Intellectual Disabilities results in a higher prevalence of Type 2 diabetes than in the general population. This is as a result of factors including a more sedentary lifestyle, high-fat diet and high levels of anti-psychotic medications, all of which can contribute to obesity.

Many people with intellectual disability do not have annual blood tests, including HbA1c, cholesterol levels and microalbuminuria; annual blood pressure and BMI measurements; or diabetic retinopathy screening.

Funding has been received from the National Institute for Health Research Health Technology Assessment (HTA) programme to explore whether a diabetes education programme tailored specifically for people with intellectual disability (DESMOND-ID) can improve self-management of Type 2 diabetes compared to usual care.

The My Diabetes and Me Study is a UK-wide randomised control trial of self-management of type 2 diabetes in adults with intellectual disabilities. The study is led by Professor Laurence Taggart at Queen’s University, Belfast and is co-ordinated by the Northern Ireland Clinical Trials Unit (NICTU).  

Colette Jackson is the Trial Manager at NICTU for this study and, with her team, has provided excellent support to the 11 participating sites across the UK, facilitating the largest UK randomised controlled trial in this population with 297 participants.

Hear more about the My Diabetes and Me Study at: https://youtu.be/IA07B1xpM9k.


Treating Type 1 Diabetes (T1D) in adolescents: the USTEK1D trial

A clinical trial investigating an established immunotherapy, originally used to treat psoriasis, has shown promising results in adolescents with recent-onset Type 1 Diabetes (T1D). The study found that the treatment can help preserve the body’s ability to produce insulin.

Funded by the NIHR Efficacy and Mechanism Evaluation (EME) Programme, the USTEK1D trial explored the use of Ustekinumab in 72 young people aged 12 to 18 who had been diagnosed with T1D within the previous three months. The aim was to slow or prevent the loss of insulin-producing cells.

Diabetes Awareness Week - USTEK1D Trial Logo

The trial involved researchers from Cardiff University, Kings College London, Swansea University and the University of Calgary, with the Swansea Trials Unit providing trial management, regulatory advice, data management, statistical analysis, QA, and PPI coordination.

Slowing the immune attack
After 12 months, participants who received Ustekinumab were producing around 49% more of their own insulin compared to those in the control group, who received matched placebo injections.

Laboratory analyses also showed that the treatment reduced levels of immune cells producing the IL-17 protein. Importantly, those participants with the biggest reductions in IL-17-producing cells saw the greatest preservation of their insulin-producing capacity. This provides the first clear trial-based evidence of the damaging role these cells play in T1D.

Next steps
While these findings are encouraging, further studies are needed to confirm the results and to better understand which patients are most likely to benefit. On its own, Ustekinumab does not appear to completely halt the autoimmune process, and some loss of insulin-producing capacity occurs before treatment takes effect.

Future research may look at combining Ustekinumab with other therapies to provide greater protection for insulin-producing cells. Even so, this trial marks an important step forward in the move towards more precise, targeted treatments for T1D, aimed at maximising benefit while minimising side effects.

Find out more

STU trial webpage: https://www.swanseatrialsunit.org/trials/ustekid

USTEK1D final report to NIHR: https://www.journalslibrary.nihr.ac.uk/eme/FQLN7416

Final results published in Nature Medicine: https://www.nature.com/articles/s41591-024-03115-2


RECOGNISED – A Randomised Controlled Trial of Continuous Glucose Monitoring in the Management and Diagnosis of Gestational Diabetes

The RECONGISED trial is an NIHR-funded study evaluating whether the use of continuous glucose monitoring (CGM) devices improves health outcomes for mothers and babies in women with gestational diabetes mellitus (GDM), compared to standard finger-prick blood glucose testing.

Gestational diabetes is the most common medical complication in pregnancy, affecting up to 20% of pregnant women in the UK. The risk of obstetric and neonatal complications in women with GDM is up to three times that of the general antenatal population.

Diabetes Awareness Week - RECOGNISED Trial Logo

CGM is already established in the management of other forms diabetes, and it offers a potentially easier and more convenient method of tracking glucose levels. It can also provide a more detailed and accurate picture of blood glucose patterns, monitoring levels continuously throughout the day and night, enabling clinical teams to optimise care and reduce the risk of complications.

The study, led by Associate Professor Christy Burden (University of Bristol) and Professor Eleanor Scott (University of Leeds) is coordinated by the Bristol Trials Centre (BTC) at the University of Bristol and is due to begin recruitment in early 2027. The BTC will collaborate with 25 maternity centres across the UK to recruit over 2,000 pregnant women from diverse populations with gestational diabetes.

With the support of the experienced team at BTC, the study aims to provide robust, high-quality evidence which could influence national guidance on the use of CGM technology for gestational diabetes.

Further information can be found here: https://fundingawards.nihr.ac.uk/award/NIHR170211


DiRECT – Transforming Type 2 Diabetes Care Through Remission Research

The Diabetes Remission Clinical Trial (DiRECT) was a landmark UK study investigating whether substantial weight loss could achieve remission of type 2 diabetes. Conducted in NHS primary care settings, the trial tested an intensive weight-management programme involving a low-calorie diet, structured food reintroduction, and long-term weight maintenance support. The study demonstrated that nearly half of participants achieved diabetes remission after one year, challenging the long-held belief that type 2 diabetes is inevitably progressive.

The impact of DiRECT continues to grow. Analyses from the 5-year follow-up data, published in 2026, provided a unique assessment of cost-effectiveness based on actual NHS resource utilisation rather than predicted disease outcomes. The findings suggest that, if implemented routinely across the NHS, the DiRECT/Counterweight intervention becomes cost-saving after approximately five years. Further analyses also showed that routine liver function tests could identify improvements in liver health, with the intervention reversing abnormalities associated with Metabolic Dysfunction-Associated Steatohepatitis (MASH) in around one-third of participants.

Glasgow Clinical Trials Unit (GCTU) and the Robertson Centre for Biostatistics (RCB) managed the data management, statistical and methodological aspects of the DiRECT trial, with Professor Alex McConnachie serving as Trial Statistician.

Building on the success of DiRECT, GCTU and RCB are also supporting Co-DIRECT Nepal, an ongoing follow-up study adapting the diabetes remission approach for a different healthcare setting. Funded by the Medical Research Council through the Global Alliance for Chronic Diseases (GACD) Healthy Cities Programme, Co-DIRECT Nepal is a hybrid effectiveness-implementation trial evaluating whether a low-cost, community-delivered dietary intervention can achieve remission of screen-detected type 2 diabetes in Nepal. The study aims to generate evidence on how remission programmes can be implemented sustainably and equitably in low-resource settings.

DiRECT has transformed expectations for people living with type 2 diabetes by demonstrating that remission is achievable for many through significant weight loss. The findings have informed diabetes care nationally and internationally: for example, GPs can now refer people with newly-diagnosed type 2 diabetes into NHS diabetes remission programmes based on DiRECT around the UK.  This has given thousands of people access to evidence-based interventions that can reduce medication use, improve quality of life, and lower the risk of long-term complications.

The wider impact of the work continues to be recognised. In 2026, the DiRECT diabetes remission programme was shortlisted for the Prix Galien UK Award for Best Public Sector Innovation, reflecting its contribution to improving population health and healthcare delivery.

You can find out more about DiRECT at: https://www.directclinicaltrial.org.uk/


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Kerry Hood made Fellow of the Academy of Medical Sciences

We are delighted to announce that Kerry Hood, Director of the UK Registered CTU Network, has been elected as a Fellow of the Academy of Medical Sciences (AMS).

Kerry Hood made Fellow of the Academy of Medical Sciences

The Academy awards Fellowship to individuals who have made outstanding contributions to the medical sciences, whether through ground-breaking discoveries or a sustained record of influential scholarship.

Kerry is among 60 outstanding biomedical and health scientists included in the Academy’s 2026 cohort, in acknowledgement of their significant contributions to advancing medical science.

The 2026 intake joins a Fellowship of more than 1,500 researchers, who contribute to the Academy’s work to support scientific talent and help shape research and health policy in the UK and around the world.

Kerry’s research has focused on the design and delivery of complex clinical trials, particularly in primary care, infections and learning disabilities.

Alongside her leadership of the Network, Kerry is Dean of Research & Innovation in the College of Biomedical & Life Sciences at Cardiff University. She has been closely involved with the UK CTU Network since its inception in 2007, initially as Director of the South East Wales Trials Unit and subsequently of the Centre for Trials Research. Throughout this time, she has been a strong advocate for academic clinical research, championing its importance at local, regional and national levels.

You can read the Academy of Medical Sciences’ announcement here.

Read more about the work of the UK Registered CTU Network here.

International Clinical Trials Day 2026

The Registered Clinical Trials Unit (CTU) Network is proud to support International Clinical Trials Day (20 May).

The date marks an important moment back in 1747, when Royal Navy surgeon James Lind set out to better understand scurvy. His study was small, just 12 men over six days, but it showed that citrus fruits could prevent the disease, and is often seen as one of the first clinical trials.

Now, the anniversary is used around the world to highlight the importance of clinical trials and recognise the people who make them happen. Registered CTUs across the Network take the opportunity to share their work in schools, hospitals, and universities around the country or hold internal events to meet and thank participants and funders. You can read about a small fraction of these activities below. To find out about more about what CTUs do click here.

If you’re interested in taking part in health and care research across the UK, the Be Part of Research website can help you explore ongoing clinical trials by condition or location.


Paper Aeroplane Trial
19 May 2026
NHS Blood and Transplant Filton

NHS Blood and Transplant Logo - International Clinical Trials Day 2026

Staff from the NHS Blood and Transplant Clinical Trials Unit will be running a mini randomised controlled trial at the NHSBT site where our statisticians are based. We aim to test the hypothesis that paper aeroplanes made from A7 paper will fly further than those made from A6 paper. Participants (NHSBT colleagues) will be randomly allocated a paper size, build a plane, and test its flight distance. To explore the reliability of self‑reported data, participants will rate their paper‑aeroplane‑making skills beforehand. We will share the results with colleagues at the site.

Find out more about the work of the NHS Blood and Transplant Clinical Trials Unit here.


Community Engagement and Creative Trial Showcase
19 & 20 May 2026
Keele University, Newcastle-under-Lyme Town Centre and Queen Elizabeth Hospital, Birmingham

Keele CTU - International Clinical Trials Day 2026

To mark ICTD, staff from Keele Clinical Trials Unit will be taking part in a creative research methods showcase at our university (19 May 2026), demonstrating the participant experience in a randomised controlled trial. On the day itself, we’ll be collaborating with MPFT NHS Trust on their research bus in Newcastle-under-Lyme town centre, engaging the public and promoting opportunities to take part and get involved in health research. We will also be showcasing our mock trial at an event at Queen Elizabeth Hospital, Birmingham, highlighting the value of high-quality clinical trials.

Find out more about the work of the Keele Clinical Trials Unit here.


Research and Knowledge Exchange Festival 2026
20 May 2026
University of Lancashire

University of Lancashire Logo - International Clinical Trials Day 2026

On 20 May 2026, leading researchers from the Lancashire Clinical Trials Unit will be presenting at the University of Lancashire’s annual Research and Knowledge Exchange Festival.  As part of a day dedicated to health and wellbeing, they will be discussing some of their ground-breaking clinical trials and innovative methodological studies that are driving the future of health research.

Find out more about the work of the Lancashire Clinical Trials Unit here.


A visit from the family of Norman Hunter
20 May 2026
University of Leeds

Leeds Clinical Trials Research Unit Logo - International Clinical Trials Day 2026

To help us celebrate International Clinical Trials Day, Leeds Clinical Trials Research Unit will be getting a visit from the family of former Leeds United footballer, World Cup winner and PFA Player of the Year Norman Hunter. Norman spent seven years receiving care in Leeds following his diagnosis with Chronic Lymphocytic Leukaemia (CLL) until his death in 2020.

His wife Sue has been raising money ever since and some of the over £170,000 raised has gone to help fund lab work related to the FLAIR and STATIC trials. In the past the family have visited the labs to meet the team and learn about the impact of their fundraising but this year they will be visiting LICTR to see where the trials are coordinated, meet the team and hear more about what is involved in running clinical trials.

Find out more about the work of the Leeds Clinical Trials Research Unit here.


Strengthening Quality and Capacity in UK Clinical Trials

The UK Registered CTU Network was created in 2007 in response to a shared recognition among researchers and funders that the UK needed greater capacity and consistency in the design and delivery of high‑quality academic clinical trials. Established alongside the growth of the National Institute for Health and Care Research (NIHR), the Network provides a coordinated, nationally accessible system that connects CTUs with funders, regulators and other key stakeholders, while supporting best practice through shared expertise and independent review.

Central to this mission is the Network’s registration process. Registration serves as a visible and trusted benchmark of quality for non‑commercial academic clinical trials, enabling funders, collaborators and participants to identify CTUs with the expertise, infrastructure and systems required to deliver robust and ethical research. In our current rapidly evolving trials landscape, clear and credible standards remain as essential as ever.

This review placed strong emphasis on engagement with a broad range of stakeholders, including CTU staff, research participants, funders and regulators. Their input was vital in testing whether the existing criteria continued to reflect quality and competence, and in identifying opportunities to future‑proof the process.

Stakeholders were invited to review how clear and effective the current criteria are, covering areas such as portfolio, staff expertise, infrastructure, quality assurance, information systems, research strategy, national standards (e.g. PPI&E), and statistics. Patient and public contributors took part in several workshops, allowing more detailed feedback to be gathered. Views were also sought on renewal timelines for existing members and on the approach to open calls for new CTUs. All feedback was considered by the Criteria Review Group, set up to oversee the process, as well as by the Executive Group and the independent International Registration Review Committee.

Overall, respondents supported the current approach, with no major structural changes recommended. However, several thoughtful refinements were agreed. These included clarifying expectations around the completion and publication of randomised controlled trials, broadening the way CTUs can evidence contribution beyond named authorship, strengthening PPI&E criteria, introducing an Equality, Diversity and Inclusion element, updating language in the Information Systems and Statistics sections to reflect current practice, and making the frequency of open calls clearer and more predictable.

This review has reaffirmed the strength of the existing registration framework and highlighted its continued value. By maintaining a clear marker of excellence across all stages of non‑commercial trials, the CTU Network continues to play a vital role in supporting high‑quality research and safeguarding the UK’s global reputation for clinical trials excellence.

Of the registration process, Otavio Berwanger, Chair of the International Registration Review Committee said:

“Being part of the UK Registered Clinical Trials Unit (CTUs) Network isn’t just about recognition; it genuinely strengthens how CTUs design and deliver trials. The registration criteria help ensure the right expertise, processes, and governance are in place to run studies that are both robust and reliable, ultimately improving the quality of the evidence we generate.”

To view the updated criteria, and the associated guidance, please click here.

UK CTU Network publishes practical guidance to support international clinical trials

The UK Clinical Trials Units (CTU) Network has published new guidance to support researchers considering running clinical trials beyond the UK, offering practical advice for navigating the complexities of international collaboration.

The document takes the form of a “Things to Consider” guide, reflecting the wide variation in experiences across UK-based CTUs involved in international studies. It aims to provide a flexible and practical list of important areas for trial teams to bear in mind at the planning stage of multi-national research.

Supporting global trial delivery

Interest in conducting clinical trials across borders has grown significantly in recent years, driven by the need for larger, more diverse participant populations and the opportunity to address global health challenges. However, running trials outside the UK introduces a range of operational, regulatory, and cultural considerations.

The CTU Network highlights that experiences of international working differ considerably depending on the country, the trial design, and the timing of the work. As a result, producing rigid, one-size-fits-all guidance was seen as neither feasible nor helpful.

A practical approach

The new document draws on the shared experience of the UK CTU community to outline key areas that research teams should consider when planning international activity. These include costing and funding arrangements, understanding cultural and local contexts, navigating contracts and legal frameworks, and managing ethics and regulatory approvals across different jurisdictions.

The guidance also provides signposts to a range of existing resources developed by other organisations, helping researchers access more detailed or country-specific information where needed.

Developed through shared expertise

The guidance has been developed by a group of senior trialists from across the UK CTU Network, bringing together experience of designing and delivering trials in a wide range of international settings. This collaborative approach reflects the Network’s commitment to sharing knowledge and promoting best practice across registered CTUs, ensuring that collective learning benefits the wider trial community.

Learning from shared experience

A key message is the value of learning from colleagues. The CTU Network encourages researchers to connect with teams who have direct experience of working in particular countries, recognising the practical insights this can provide when navigating unfamiliar systems.

Researchers interested in speaking with colleagues from other CTUs can contact the Network, which will seek to connect them with individuals who have relevant international experience.

A living resource

By taking a principles-based approach, the Network hopes that the document will remain useful over time in a rapidly evolving landscape for global clinical research. Rather than attempting to keep pace with changing regulations and processes in every country, it provides a framework for thinking through key issues and making informed decisions.

The guidance is intended for anyone involved in trial design and delivery, including trial managers, statisticians, and chief investigators considering international expansion.

You can download the guidance here.

Dementia Disco: Inspiring memories, conversation, and friendships though music

A personal reflection on dementia, research, and advocacy by Simon Denegri OBE, Chair of the CTU Network Executive Group, Chair of Dementia Disco, and Chair of Sense About Science.

My story with dementia begins as a teenager in the late eighties. My grandmother was staying with us to give my aunt, her carer, a break. My parents had gone out after helping my grandmother to bed. There was a loud crash from the bedroom next door to mine and I found her lying on the floor, confused and disorientated. To this day I remember the frailty of her body in my arms and her vulnerability as I placed her back in bed. It was the moment when dementia invaded my young world with shocking reality.

That is the beginning of my story with dementia and I am choosing to tell it – as I hope so many others will – as part of Dementia Action Week and the Alzheimer’s Society’s ‘Forget-Me-Not campaign this week (18 – 25 May).

My personal experience of dementia has had a strong bearing on my career from the early nineties when I was the Alzheimer’s first parliamentary officer and public awareness of the disease was only just stirring. Right up to the present day and my role as Chair of Dementia Disco, a small but rapidly growing charity which aims to use music to inspire memories, conversation and friendships in and between people living with dementia.

People at the Dementia Disco
Dementia Disco logo
People at the Dementia Disco

Dementia was my introduction to research and to public involvement. The Alzheimer’s Society was the first charity to pioneer in the nineties involving patients and carers in decisions about research funding. Seeing this unfold had a formative influence on me: public involvement is about bringing social justice and democracy to one of the most important human endeavours – science – and making it more relevant to society. I am lucky to have had the chance to make this happen more widely in the UK and globally with some amazing patient partners, clinicians and researchers.

It is therefore a happy coincidence that this week we also celebrate International Clinical Trials Day (ICTD) on 20 May. For some time ICTD has been used by NIHR, charities and members of the UK Registered CTU Network as well as many others to raise public awareness of the importance of clinical trials. More importantly to encourage people to volunteer to take part in studies. Hundreds of thousands of people are now signed up to NIHR’s ‘Be Part of Research’ matchmaking service which enables patients and researchers to connect about opportunities. But we need many more volunteers in research in the future and it is important that the Government has made a commitment to make this easier to do as part of its NHS 10-Year Plan.

The dementia community has again been a pioneer here. It is eleven years since Join Dementia Research was set up. Over 100,000 people have registered and hundreds of studies have recruited volunteers by using this service. It has undoubtedly been an important element in the exciting developments now taking place in UK dementia research. We may still have a long way to go before we cure dementia but research and improvements in treatments and care mean that many people can now live fuller lives for longer – perhaps even connect with others at a Dementia Disco.

In recent months there have been several public attitudes surveys showing that public trust in science remains high but is fragile. Also that they are often overwhelmed by the way in which science is communicated. But that telling stories enable them to connect with and see its importance to their life and that of their community.

In dementia, in clinical research, across science in general we must continue to tell stories which bring opportunity and hope to our fellow human beings. It was a pleasure to share my story and I hope you will pass it on. Better still please tell your own story.

Simon Denegri OBE

New study surveys UK practice in central data monitoring for clinical trials

A newly published academic paper has shed light on how central data monitoring is currently undertaken across registered clinical trial units (CTUs) in the UK, highlighting both strengths in existing practice and areas where greater consistency could support trial quality.

Titled Central data monitoring of clinical trials: A survey of the UK Registered CTU Network, the paper reports findings from a national survey exploring how central data monitoring (CDM) is planned, delivered and documented within UK Registered CTU’s. The work reflects close collaboration across the UK trial methodology community and contributes to ongoing efforts to improve the conduct and efficiency of clinical research.

The paper will be of interest to trialists, methodologists and research professionals involved in trial design, conduct and oversight, particularly those seeking to strengthen proportionate and effective monitoring strategies.

What Is Central Data Monitoring?

Central data monitoring refers to a range of activities carried out by trial staff while a study is ongoing, with the aim of safeguarding data quality, integrity and reliability. Unlike on-site monitoring, these activities are performed remotely and often involve routine review of trial data, processes and performance indicators. While CDM is widely recognised as an essential component of good trial conduct, there is limited regulatory guidance on which activities should be undertaken or who should be responsible for them.

Findings and Recommendations

To better understand current practices, the research team distributed a structured survey to all UK Registered CTU’s on 25 April 2025. The survey asked respondents to indicate whether 16 defined central monitoring activities were carried out on all trials, some trials or not at all, and which staff roles were typically involved in delivering each activity.

The results show considerable variation across CTUs. Central data monitoring is commonly undertaken by statisticians, trial managers and data managers, alongside other trial team members depending on the activity. While some monitoring practices were widely and consistently applied, others were implemented more selectively, often influenced by trial design, risk profile or available resources.

Notably, the authors highlight the lack of detailed regulatory direction as a key factor contributing to this variability. In response, the paper proposes a core set of eight central data monitoring activities that the authors recommend should be considered for inclusion in all clinical trials, providing a potential baseline for more standardised practice.

The authors express their sincere thanks to all CTUs and colleagues who contributed to the survey, recognising the time and expertise required to share detailed information on internal processes.

Read the full paper here.

Find more guidance on monitoring issues here.

Dementia Trials Around the Network

Dementia Action Week is an awareness campaign led by the Alzheimer’s Society, bringing people and organisations together to take action on dementia.

Dementia is the UK’s leading cause of death, and around one in three people born in the UK today will develop it during their lifetime.

Across the country, many Registered Clinical Trials Units (CTUs) are carrying out vital research into dementia, from prevention and treatment to better support for carers. Below, you can read about just a few of these important studies.


SleepBoost: Could improving sleep help prevent Alzheimer’s dementia?

The SleepBoost study is one of five new MRC-funded studies awarded £16.5 million to help identify new ways to treat or slow down neurodegenerative diseases before symptoms worsen.

Over 55 million people live with dementia, costing over US$1.3trillion worldwide. Alzheimer’s disease, the commonest cause of dementia, is slowly progressive, with changes in the brain long before noticeable clinical symptoms.

Earlier treatment is best for people to keep their independence and quality of life.

Sleep Boost study logo - Dementia Trials Around the Network

The SleepBoost study, led by Professor Coulthard and the Bristol Trials Centre at the University of Bristol, will focus on a phase of sleep known as slow-wave sleep, which plays a key role in removing harmful proteins from the brain. The study is currently in set up with an aim to begin recruitment later in the year.

The study aims to assess whether improving sleep helps prevent Alzheimer’s dementia. The study will specifically improve the quality of slow-wave (deep) sleep and measure the effect on Alzheimer’s markers in the blood. Recruitment will take place across 11 locations in the UK, with a focus on including South Asian communities who may be more affected by poor sleep. By using sleep recordings, brain activity monitoring, scans, blood and spinal fluid samples, and memory tests to measure impact, we hope our findings will lead to a better understanding of the links between sleep and Alzheimer’s. Our vision is a new class of tailored Alzheimer’s disease treatments based on a new mechanism of neurodegeneration.

Find out more here: https://www.bristol.ac.uk/news/2026/january/165-million-to-investigate-neurodegenerative-diseases.html


Rare Dementia (RD) – TALK

RD-TALK is a National Institute for Health and Care Research (NIHR, https://www.nihr.ac.uk/) funded research programme that focuses on rarer dementias that are either genetic (such as familial Alzheimer’s disease or familial frontotemporal dementia) or non-memory led, involving initial difficulties with language (PPA), vision (PCA) or personality changes (bvFTD).

As part of the RD-TALK programme two RCTs are being conducted, BELIDE and IWARF.

BELIDE assesses the effectiveness of an online education course programme (“Better Living with non-memory led dementia”) in improving the psychological wellbeing of carers of people with rarer dementias. IWARF examines the effectiveness of a digital programme (“Improving Wellbeing Associated with Rare Familial dementias”) in improving the psychological wellbeing of people at risk of genetic dementia.

NWORTH CTU (https://www.bangor.ac.uk/nworth), which is a member of the UK Registered CTU Network, manages the data, statistical and methodological aspects of both the BELIDE and IWARF RCTs. Dr Joshua Stott is the Chief Investigator and the Trial Statistician is Dr Andrew Brand.

For further information about RD-TALK research programme, please visit: https://www.raredementiasupport.org/research/rd-talk/


The CareCoach Study: Empowering Carers of People Living with Dementia

The CareCoach Study, coordinated by the Norwich Clinical Trials Unit (CTU) at the University of East Anglia and funded by the National Institute of Health and Care Research (NIHR), is testing whether an online package of support for carers of people with dementia has an effect on the carer’s mood, their overall quality of life and/or their sense of being able to care well.

As part of the study, CareCoach provides carers with access to online learning modules and support from a ‘coach’ (health, social care or charity worker) over 8-weeks.

Care Coach study logo - Dementia Trials Around the Network

CareCoach is a support package that can be delivered remotely. This allowed the research team to recruit carers from across the UK remotely via social media and healthcare services. Advertising the study on social media proved to be a successful way to reach carers. So successful that 18% of participants (73 carers) joined the study through social media!

Managing the trial centrally at the Norwich CTU was key in ensuring data was high quality and strong recruitment. This streamlined approach helped the study meet its recruitment target (404 carers) on time within 12 months. In fact, CareCoach was one of the fastest recruiting trials funded by NIHR in 2025-2026 in the UK.

Strong interest from carers wanting to take part in the study highlights the need for more support for those caring for people living with dementia. Results are expected later this year, with plans to explore making CareCoach available to carers who need it most.

Read more about CareCoach: https://carecoachtimes.org/carecoach/

A participant shares their CareCoach experience: https://news.joindementiaresearch.nihr.ac.uk/how-dementia-research-is-helping-support-carers/


“Being Kind to Ourselves” study – a full-scale Randomised Controlled Trial (RCT) evaluating Compassion Focused Therapy (CFT) for improving depression and anxiety in individuals with dementia

NWORTH is excited to announce that the “Being Kind to Ourselves” study – a full-scale Randomised Controlled Trial (RCT) evaluating Compassion Focused Therapy (CFT) for improving depression and anxiety in individuals with dementia – was granted NIHR RfPB funding in August 2025 (NIHR209908). The study is led by Chief Investigator Prof Aimee Spector; Rachel Evans is the Senior Statistician and Co-investigator.

This RCT directly follows the success of the preceding NIHR RfPB-funded feasibility trial (NIHR203524), which demonstrated the potential of group CFT for participants living with dementia and depression and/or anxiety. This successful groundwork provides a robust foundation for the larger, definitive study.

NWORTH CTU logo - Dementia Trials Around the Network

The feasibility phase data will serve as an internal pilot and will be incorporated into the final trial dataset. The full RCT requires a total sample of 304 participants. Importantly, 73 participants have already been successfully recruited and randomised during the feasibility phase. Therefore, the primary recruitment goal for this next phase is securing a further 231 participants to reach the required sample size. Recruitment is scheduled to commence in January 2026.

The trial is building upon the established infrastructure of the initial study. While 7 sites participated in the feasibility trial, some of which will continue with the RCT, complemented by the opening of new sites to accelerate participant enrolment.

The first time this model of funding has been used by NWORTH CTU and offers an exciting opportunity to optimise existing resources and accelerate the RCT timeline.


Read a personal reflection on dementia, research, and advocacy by Simon Denegri OBE, Chair of the CTU Network Executive Group, Chair of Dementia Disco, and Chair of Sense About Science here.

Promoting Greener Trials

The environmental impact of clinical trials

Climate change is the biggest health threat facing humanity. Yet healthcare, including clinical trials, contributes to the problem by producing 4-5% of global greenhouse gas emissions. Promoting greener, more sustainable practices in clinical research is essential to reducing the environmental impact of our work.

Developing a method to footprint clinical trials

As a first step towards lower carbon trial design, a method and guidance to carbon footprint publicly funded clinical trials was developed by UK Registered CTU Network trialists based at the ICR-CTSU and the University of Liverpool. The initial guidance was piloted on two CRUK-funded, ICR-CTSU managed trials https://pubmed.ncbi.nlm.nih.gov/38267250/.

Collaboration with 7 more UK Registered CTU’s (Centre for Trials Research, Centre for Healthcare Randomised Trials, Edinburgh Clinical Trials Unit, Imperial Clinical Trials Unit, Newcastle Clinical Trials Unit, UCL Innovative Clinical Trials Unit (formerly MRC CTU at UCL), Liverpool Clinical Trials Centre) and 3 international CTUs (Cancer Trials Ireland, Trinity College Dublin and CTN Diabetes and Institute for Clinical Trials, and The George Institute for Global Health) further tested and refined the applicability and usability of the method developed.

Each CTU identified a trial from their portfolio and a member of their team who could perform the footprinting of the trial. The work was performed by a variety of team members from each CTU (trial managers, MSC students, PhD students, clinicians). The work took between 5 and 60 hours per trial depending on the complexity of the trial, and how familiar the person completing the carbon footprinting was with the trial itself. This was conducted alongside existing routine workload, without specific funding to support it.

The results showed that the carbon hotspots of these trials varies but there are some key themes starting to emerge in terms of where the majority of emissions are seen.  You can read more about this work here: What is the carbon footprint of academic clinical trials? A study of hotspots in 10 trials – PubMed.

Carbon footprinting drop‑in clinics

We now need to turn carbon footprinting into action and promote a paradigm shift to lower carbon trial design and delivery.

Promoting Greener Trials - Details of Carbon Footprinting Drop In Clinics

The ICR-CTSU team, funded by Wellcome on behalf of the TMRP Greener Trials Group, are keen to support and train as many UK Registered CTU Network staff in the method of clinical trial carbon footprinting as possible. You don’t need any prior knowledge or experience of this, and we will provide all required guidance documents and tools to perform the footprinting.

By attending a Wellcome-funded carbon footprinting ‘drop-in clinic’ and footprinting a clinical trial, trial staff will have a better understanding of the environmental impact of their trials. This could help inform lower carbon trial design and, as funders begin to ask applicants to consider the environmental impact of their research, this could be a valuable addition to funding applications and progress reports.

For UK CTUs whose host institutions have signed up to the Concordat for the Environmental Sustainability of Research and Innovation Practice, this knowledge could also help teams provide the environmental impact data, required by the Concordat.

The Wellcome-funded carbon footprinting drop-in clinics run monthly, and are open to everyone and anyone, including those just wishing to learn more about the concept of carbon footprinting and Greener Trials.

For more information, contact cict-icrctsu@icr.ac.uk or visit the MRC NIHR TMRP Greener Trials website

Building the evidence base

The accumulating data on publicly funded clinical trial footprints is being collated through the trials footprinted at the clinics. These data are critical to our knowledge base and to supporting research around lower carbon trial design.

Each UK Registered CTU agreeing to share footprinting data with the Greener Trials Toolkit is contributing towards the update and refinement of the guidance, which increases its applicability to a wider variety of future trialists. The more data we have, the faster and easier we can make the calculations for future users.

We’re delighted that more and more UK Registered CTU’s are attending the clinics and sharing their data with us, most recently the Rapid Eczema Trials which are being delivered in collaboration with Nottingham CTU, and the STRATA trial delivered in collaboration with the Bristol Trials Centre and footprinted by  Bristol Medical School.

The data are also building an evidence base of where hotspots lie in trials in different therapeutic areas or using different designs and interventions. We need this information to facilitate research into mitigation strategies to reduce those hotspots, without compromising the quality of trials and integrity of trial data.

The Greener Trials Toolkit

To help speed up carbon footprinting calculations and collation of this critical data, Wellcome are also funding the development of an online, free to use, open science and fully referenced Greener Trials Toolkit.

The Toolkit, planned for release in 2026, will speed up carbon footprinting calculations and provide users with information on mitigation strategies for the hotspots identified. The Toolkit will also include a publicly accessible database of carbon emission factors and curate the data that users share with the Greener Trials Data Consortium.

Supporting sustainability across the CTU Network

The Network is also supporting CTUs in the consideration of sustainability. The UK Registered CTU Network Sustainability thematic group was recently conceived, and the group have held their first meeting and are excitedly planning the ways in which it can bring the CTU network together to share knowledge, best practice and practical experience of considering and implementing Greener Trials.

We’d like to express our huge thanks to the 10 UK Registered CTU’s and affiliates who have already footprinted trials and shared their data with the Greener Trials Data Consortium and look forward to hearing from others who may be interested in considering the carbon footprint of their trials.

To get involved, please contact cict-icrctsu@icr.ac.uk.

The Network became a supporter of the Concordat for the Environmental Sustainability of Research and Innovation Practice in June 2024.  Learn more here.

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