HHTU News Roundup

Christmas closure

The Hull Health Trials Unit will be closed from 5pm Friday 19th December 2025 until 9am Monday 5^th January 2026. We will have a skeleton team to ensure safety aspects of studies are covered over this time (except weekends and the bank holidays).

All the team at HHTU wish our colleagues and collaborators a restful Christmas break and a very Happy New Year!

The DAMPen-D 2 study is greenlighted

One-third of people have delirium when they are admitted to a palliative care unit or hospice and a further one-third develop delirium during their stay. People with delirium may see or hear things that aren’t there, say or do things that are out of character, and can’t ‘think straight’. This is distressing for the person, their family, and staff. There is clear national guidance on the actions needed to prevent, detect, assess, and manage delirium. However, it is difficult for hospices to put this guidance into practice because delirium care is complex and involves lots of different people, including family, friends and health professionals. The DAMPen-Delirium 2 team have designed a way to help hospices to overcome these difficulties and follow delirium guidelines better. They have tested this on a small scale and are now running to run a major, national trial to test whether this improves delirium care and reduces delirium in hospices.

This month the first 5 DAMPen-Delirium 2 sites, out of 20, have been greenlighted with data collection to start in January.

HHTU Director at SSA Conference

The Director of the Hull Health Trials Unit is also the Co-Director of the Centre for Addictions and Mental Health Research (CAMHR) in Hull whom we closely collaborate with. Judith and many others of the CAMHR team recently attended the Society for the Study of Addiction annual conference in Newcastle. This is the UK’s foremost gathering of addiction researchers, policymakers, practitioners and experts by experience. This conference was described as an ‘amazing opportunity’, ‘an incredible couple of days’ by members of the CAMHR team and they are ‘looking forward to building on new networks and collaborations’. 

Half year round up

As 2025 draws to a close, we’ve been reflecting on achievements of the last 6 months at the Hull Health Trials Unit.

We opened the IMPACT-W study, led by NIHR Doctoral Fellow Laura Hermann, exploring why women are underrepresented in research. We are also preparing two studies for early 2026: DAMPen-D II, supporting hospices to follow delirium guidelines and CONIFAS-2, a feasibility RCT of a home-based, family-led neurodiversity intervention. Our Data Services Team continues to support the recruiting Pharm-Air Qual Study.

Several key publications were released this year:

• The main MABEL trial results were published in The Lancet Respiratory Medicine, with the Health Economics paper in BMJ Open in November.
• The CANFit protocol paper appeared in BMJ Open in September.
• The NEWDAY-ABC pilot results were published in Pilot and Feasibility Studies in August, ahead of a full multicentre RCT launching in 2026.
• Senior Data Manager Sarah Sumper was a named author on the UKCRC guidance document Data Cleaning and Query Management.

Our Director, Judith Cohen, served on the panel for the annual Allam Lecture at Hull York Medical School, featuring keynote speaker Prof. Sir Stephen O’Rahilly.

In October, members of our Data Management team attended the UKCRC DISOG National Meeting—a valuable day of learning and collaboration, introduced by our own John Turgoose. A vendor showcase also highlighted innovations in data management systems.

Together, these achievements reflect the continued growth, dedication, and collaborative spirit of the Hull Health Trials Unit as we look ahead to 2026.

Other November project headlines:

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HHTU News Roundup

Data team attend DISOG National Meeting

In October, members of our Data Management team attended the UKCRC Data and Information System Operation Group (DISOG) National Meeting – a valuable day dedicated to learning, collaboration, and sharing best practice across the network.

The event opened with a warm welcome from our own John Turgoose (Hull Health Trials Unit) and co-chairs. Their introduction set the tone for a productive and engaging day, followed by an overview of network-wide activities which provided useful context for the sessions ahead.

A vendor showcase offered a chance to see what products and services are available to support the important work taking place across our field, highlighting the continued innovation in data management systems.

A highlight of the morning was the panel session on WAgile working — an innovative hybrid of Waterfall and Agile methodologies designed to improve database development processes for clinical trials. The discussion generated thoughtful debate and practical ideas for how centres might adopt similar approaches in their own teams.

In the afternoon, attention turned to MHRA inspections, where colleagues from other CTUs recently inspected shared their experiences and insights. Their presentations provided valuable guidance and practical advice for teams preparing for future inspections.

Overall, the meeting provided an excellent opportunity to exchange knowledge, strengthen collaboration, and reflect on the evolving landscape of data management and information systems within clinical trials. The discussions and shared experiences will undoubtedly help inform future developments across the network.

Our Senior Data Manager authors guidance

Sarah Sumper the HHTU’s Senior Data Manager has recently been a named author on the UKCRC guidance document ‘Data Cleaning and Query Management’ which is available here https://ukcrc-ctu.org.uk/is-data-management/.

The purpose of this document is to provide guidance on cleaning of data collected within a clinical database for clinical research and the management of queries.

Different trial units will have different approaches depending on the tools they are using and the type of data included in the trials. The processes may be manual, automated, or a combination / hybrid approach. This document incorporates recommendations based on the experience of the authors, representing thirteen UKCRC registered clinical trials units, with consideration to regulatory requirements. It is designed to be used as recommendation for good practice and as a starting point for new CTUs alongside their own specific guidance and SOPs.

Other October headlines:

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HHTU News Roundup

Join our team

We’re thrilled to share that, thanks to the success of our Trials Unit in securing funding for new clinical trials, we’ll soon be expanding our team. Over the coming months, a range of positions will be advertised across all areas of the Trials Unit, including data management, statistics, and trial coordination.

The jobs will be advertised on the University website here https://www.hull.ac.uk/about/jobs and we will share new posts as they go live on our LinkedIn page.

BEYOND Frontier live in the DSH

The FRONTIER Programme aims to support the early diagnosis of COPD and the timely initiation of evidence-based interventions to improve outcomes for participants in the Hull Lung Health Check Programme. BEYOND FRONTIER—a newly opened study within the HHTU Managed Data Safe Haven—builds on this work by using FRONTIER data to evaluate the performance of TidalSense Diagnostic Algorithms in identifying COPD and pre-COPD among participants. Led by Professor Mike Crooks, this marks the 32nd study supported by the Data Safe Haven, which continues to provide the secure, accredited environment that enables innovative research to take place

Allam Lecture 2025

The Annual Allam Lecture hosted by Hull York Medical School always proves to be an excellent event with members of the trials unit being able to network with the wider research community across HYMS. The poster session always proves to be a buzz with lots of interesting research and conversations. This year our HHTU Director Judith Cohen was a part of the panel this year judging the oral presentations. The afternoon wrapped up with the keynote lecutre by Prof. Sir Stephen O’Rahilly from the University of Cambridge who gave an insightful lecture titled ‘The causes and consequences of obesity; lessons from the extremes’. We are looking forward to next years Allam Lecture already.

TRE conference

John Turgoose, Information Systems Manager, and Amy Porter, Data Support Administrator, recently attended the Trusted Research Environment (TRE) Community Conference in Leeds. As the HHTU team manages the University of Hull Data Safe Haven—our own TRE—this event was a valuable opportunity to connect with others in the national TRE network. The conference’s main theme focused on federation, encouraging reflection on progress to date and open discussion around current challenges. John and Amy took part in interesting breakout sessions covering information governance principles, risk assessments, SATRE accreditation, and AI output checking, as well as a series of engaging five-minute presentations from across the TRE community.

PRE-DX results meeting

On the 26^th September, an online results meeting was held for PRE-DX  with Principal Investigators from participating sites and members of the research team. Chief investigator Henry Cain shared the results of the study, with lots of discussion around the findings and future work. The results are expected to be shared more widely next year.   

Other September headlines:

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HHTU News Roundup

NEWDAY ABC pilot study paper published

The results paper for the NEWDAY ABC pilot study was published in Pilot and Feasibility Studies (https://doi.org/10.1186/s40814-025-01689-3) in August. The NEWDAY-ABC assessed the feasibility of a co-designed weight loss intervention versus standard care in early-stage oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients. The study was set-up at the start of the pandemic, which presented challenges but intervention was found to be feasible and potentially showed benefit in aiding weight loss and other important health outcomes in women with early-stage breast cancer. A full multicentre randomized controlled trial of the NEWDAY-ABC will start in 2026.

SPOTLIGHT SERIES
02: The BREEZE-2 study

Idiopathic pulmonary fibrosis (IPF) and other fibrotic-interstitial lung diseases, collectively termed pulmonary fibrosis (PF), are progressive, incurable and ultimately fatal. Although two therapies are now available that slow the rate of lung function decline, they have failed to show improvement in symptoms or quality of life. There is limited evidence relating to the efficacy of breathlessness management in people with PF. The poor prognosis, variable disease trajectory and absence of any existing, widely accessible evidence-based treatment to improve patients’ symptoms sets PF apart from other causes of chronic breathlessness

Trial Design

Multi-centre, wait-list design, randomised, controlled trial of a complex, non-pharmacological breathlessness management intervention in people with pulmonary fibrosis (PF) and chronic breathlessness, with embedded qualitative implementation study to inform scaled NHS adoption.

Leadership and collaboration

The study is led by Dr Ann Hutchinson and coordinated by the Hull Health Trials Unit. The Hull Health Trials Unit team is expertly lead by Trial Manager Grant Constable and Data Manager Philip Best.

study progress

The study launched earlier this year, with 14 sites now open and actively recruiting participants. The final 15th site is underway with site set-up and we hope to get them open to recruitment within September.

To date, BREEZE 2 has successfully enrolled 34 participants across nine sites:

· Hull University Teaching Hospitals NHS Trust
· Manchester University NHS Foundation Trust
· NHS Lothian (Edinburgh)
· The Royal Wolverhampton NHS Trust
· Royal Devon University Healthcare NHS Foundation Trust
· University Hospitals of Leicester NHS Trust
· University Hospital Southampton NHS Foundation Trust
· James Paget University Hospitals NHS Foundation Trust
· Western HSC Trust (Northern Ireland)

We sincerely thank all our participating sites for their ongoing commitment and collaboration in driving this vital research forward.

impact and outlook

This study will allow us to test the clinical and cost effectiveness of a complex intervention to manage breathlessness and for us to understand how best to implement the intervention if found to be effective.

Other August project headlines:

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HHTU News Roundup

DOORStep survey collection ended

The DOORStep study is evaluating the effectiveness and acceptability of free door to door transport to increase the uptake of breast screening appointments in Yorkshire. To assess how women travelled to the screening sites they were asked to complete a travel survey. One for women in the intervention arm and one for those in the intervention arm. The survey collection phase of DOORStep has officially ended, and a total of 3696 responses have been collected!

A huge thank you to everyone who participated and helped us gather valuable insights. Work now moves onto the next phases of DOORStep including qualitative interviews and their subsequent analysis.

SPOTLIGHT SERIES
01: The ACESO Study

The ACESO study is a UK clinical trial investigating a promising new treatment approach for acute severe ulcerative colitis (ASUC), a life-threatening flare of ulcerative colitis that often requires hospitalisation and intensive therapy.

Currently, patients with ASUC are treated first with intravenous corticosteroids. However, about half do not respond sufficiently, leading to the use of additional “rescue” therapies or even surgery, including colectomy. The ACESO trial tests whether adding upadacitinib—an effective, fast-acting medication approved for ulcerative colitis—at the start of steroid treatment can improve patient outcomes and reduce the need for further interventions.

Trial Design

This Phase III, randomized, placebo-controlled study plans to recruit 300 participants across approximately 30 UK hospitals. The trial will evaluate if combining upadacitinib with steroids leads to faster clinical response, fewer surgeries, and shorter hospital stays.

Leadership and Collaboration

The study is led by Prof. Shaji Sebastian at Hull University Teaching Hospitals NHS Trust and coordinated by the Hull Health Trials Unit and collaborating with many NHS trusts and academic centres across the UK. The Hull Health Trials Unit team is expertly lead by Trial Manager Mahe Haji Sadeghi and her hardworking team of Trial Coordinators Charlotte Thompson and Paul Bradley as well as skilled Data Managers Beccy Acaster and Sarah Sumpter.

Study Progress

The study launched earlier this year, with 10 sites now open and actively recruiting participants. An additional 10 sites are currently going through the approval (“greenlight”) process to begin recruitment soon, while another 10 are being set up to meet the target of 30 sites. To date, ACESO has successfully enrolled 24 participants across five sites:

• Hull University Teaching Hospitals
• St George’s Hospital
• Royal Devon University Healthcare
• Cambridge University Hospitals
• Kettering General Hospital

We sincerely thank all our participating sites for their ongoing commitment and collaboration in driving this vital research forward.

Impact and Outlook

If successful, the ACESO trial could significantly improve the care pathway for patients experiencing acute severe ulcerative colitis, reducing the burden of surgery and prolonged hospital stays. This trial represents a critical step toward faster, more effective treatment for a condition that affects thousands of people annually.

Other July project headlines:

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HHTU News Roundup

A half year roundup

Unbelievably as we are at the halfway point of 2025, it seems like a good time to reflect on what has been a busy first six months of the year and to look forward to what the next six months has to bring.

The STARLIT programme of work kicked things off in January with the final study report submitted to the NHS Research Ethics Committee and the STARLIT-2 protocol paper published in the BMJ Open. The third STARLIT study opened to recruitment in March with 9 participants consent to date.

Another new study progressing well is BREEZE-2 which opened in March with has 12 site opens and  has recruited 12 participants. The third new trial to open was ACESO which opened April and is already at 12 participants with 6 sites open which is a really positive start.

HHTU Director Judith Cohen gave a presentation to the Hull York Medical School on International Women’s Day detailing the interesting journey her career has taken from A levels to being the Director of HHTU and Co-Lead of the new NIHR Centre for Addictions and Mental Health Research.

Trial Manager Matthew Northgraves secured his first research grant to embed a study within a trial (SWAT) in a HHTU study and also presented to at the UKCRC (UK Clinical Research Collaboration) trial manager operations group ‘Insights for Trial Managers from around the Network’ webinar, one of our previous SWATs. Highlighting some of the methodological work we are doing at the HHTU.

With more new studies in set-up in the second part of 2025 the year promises to continue to be a busy one…

Other June project headlines:

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HHTU News Roundup

TM joins the UKCRC Trial Management Operations Group

Congratulations to HHTU Trial Manager Matthew Northgraves, who has been successful in becoming a member of the UKCRC CTU Network Trial Management Operations Group. The group aims to develop and share best practices to promote high-quality, effective trial management in member CTUs. Matthew becomes the second member of the HHTU currently represented on a UKCRC Operation Group with Information Systems Manager currently the joint chair of the Data & Information Systems Operations Group.

BREEZE-2 has its first recruits

The BREEZE 2 study has successfully recruited its first four patients. These were from sites across the UK including Hull, Southampton and C-TRIC (Northern Ireland).

Trial Manager Grant Constable has worked with Interstitial Lung Disease centers across the UK to get nine sites currently open to recruitment with a further six close behind them.

We’re very excited to get this study on the go and we’re optimistic the BREEZE 2 Intervention will provide relief to those suffering from breathlessness; building on the success of the feasibility study.  You can read more about the BREEZE 2 study here.

Papers published

Two papers have been published in May for studies the HHTU were involved in.

The first paper for EXACQUAL which was published in BJGP Open  (https://bjgpopen.org/content/early/2025/05/04/BJGPO.2024.0026). EXACQUAL was an interview study conducted during the pandemic and explored the experiences, expectations and understanding of exacerbations of COPD patients and their carers before and after the emergence of COVID-19. 

The second was the results paper for the Cognitive Daisy (COG-D) in care homes to support person-centred care feasibility cluster Randomised controlled trial. This was published in Pilot and Feasibility Studies https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-025-01637-1.

HHTU Director Prof Judith Cohen was part of the research team for both and the HHTU provided study management support and data management for the ExacQual Study and the data services for COG-D.

COACH-AC open to recruitment

We are pleased that this month COACH-AC has opened to recruitment. The HHTU are providing the data services for this project. Sarah Sumpter our Senior Data Manager has been working with Dr Philppa Case, the Chief Investigator of this project, to create the electronic data capture database for this study in REDCAP Cloud. As well as this, folders in our secure area of Box have been created for the storage and analysis of other data and the relevant information governance documentation have been completed, reviewed and approved to ensure that the processing is meeting the necessary data protection standards.

Philippa’s study is aiming to understand the prevalence, coexisting conditions and care offered to adults admitted to hospital with coexisting alcohol use disorder and cognitive impairment. Already the team of research assistants in this study have recruited over 40 participants!

If you have a project that, like Philippa’s and COG-D above, requires electronic database or data storage please get in touch with the data team via hhtudatateam@hyms.ac.uk. You can also find more information about the data services we provide here. https://hhtu.hull.ac.uk/our-research/data-services.

Other May headlines:

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HHTU News Roundup

ACESO up and running

We’re thrilled to announce that the ACESO study officially got underway in April! After months of dedicated planning, the team has successfully secured overall study sponsor greenlight and officially opened our first site at Hull University Teaching Hospital.

Even more exciting — our very first participants have now been recruited.

This marks a huge milestone in what promises to be an impactful journey. With plans to open 30 sites across the UK and recruit 300 participants, we’re just at the beginning of an ambitious two-year mission to drive meaningful research forward.

Stay tuned — the ACESO story is just getting started!

HHTU Trial Manager completes the Building Brilliant Leaders programme

Trial manager Matthew Northgraves became the second member of the HHTU to complete the University’s Building Brilliant Leaders Programme. The programme was designed to develop leaders who understand their impact on their people’s wellbeing, who actively create an inclusive culture and who can work with people as individuals to bring out the best in everyone. Matthew said:

“The programme has really highlighted the importance of recognising the needs of the specific individual to ensure you get best out of them whilst creating clear goals for my own future development”.

DOORstep study on the move

We’re pleasede to share the latest progress on the Doorstep Study — and things are moving full speed ahead!

As of the end of April:

✅ 7 GP practices have been randomised, with just one more to go!
🎯 Of these, 4 are in the intervention group and 3 in the control group.

Women registered at the intervention practices are being offered free door-to-door transport to attend their routine breast screening appointments — making it easier than ever to prioritise their health.

📬 So far, over 3,000 women from three participating GP practices have received their screening invitations from the Humberside Breast Screening Service. Among those who attended their appointments, the Doorstep team collected more than 1,600 surveys, marking a significant step forward in gathering meaningful feedback from participants.

We’re incredibly proud of the momentum so far and can’t wait to see the full impact of this innovative, community-driven approach to improving breast cancer screening access.

Stay tuned — the journey continues!

April project headlines:

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HHTU News Roundup

Trial manager presents to UKCRC Trial Manager Operations Group

Trial manager Matthew Northgraves presented at the UKCRC (UK Clinical Research Collaboration) trial manager operations group ‘Insights for Trial Managers from around the Network’ webinar on the 26^th March 2025. With around 100 people in attendance from across the UKCRC network, it was great to see some of the Trials Unit’s methodological work presented more widely. 

HHTU Director presents for International Women’s Day

As a part of the Hull York Medical School celebrations for International Women’s Day, the director of HHTU, Professor Judith Cohen, presented on empowering women in clinical research and paving the path to leadership and inclusion.

Professor Cohen detailed her own career journey, from her A Levels in science and maths to Director of HHTU and Co-Lead of the new NIHR Centre for Addictions and Mental Health Research.

Her interesting presentation discussed gender stereotypes and biases leading to women and girls being discouraged from pursuing careers in clinical research and highlighted the positive action that can be taken to address this gender gap.  These include, engaging girls into science subjects from an early age, creating inclusive workplaces, providing mentorship opportunities and increasing women’s participation in clinical trials. 

Important findings from a DSH project

Dr Ben Pickwell-Smith has used the University of Hull Data Safe Haven (which is managed by Hull Health Trials Unit) to carry out analysis needed for his PhD. His study was looking at whether there are socio-economic inequalities in the diagnosis and treatment of colon and ovarian cancer in England. To do this a successful application was made through the very strict DARs process. This process ensures that we meet very detailed data governance standards and can demonstrate we are able to look after sensitive data. In this study the dataset linked cancer diagnosis information from the National Disease Registration Service (formally National Cancer Registration and Analysis Service) and Hospital Episode Statistics (information about when a person visits hospital) from NHS England (formally NHS Digital) between 2016-2017.

Ben’s research has found that women living in the most disadvantaged areas of the country were 32% less likely to receive surgery and chemotherapy for ovarian cancer compared to those from more affluent areas. Surgery and chemotherapy are the main treatments used in the care of people with ovarian cancer, and those who receive them are more likely to survive. You can read more about Ben’s results in a recent Hull York Medical School article here and read the paper published in Cancer Epidemiology here.

The Data Safe Haven are available to assist with applications to data providers such as NHS England or the National Disease Registration Service. You can email us on DSH@hull.ac.uk to ask any questions or visit out website https://datasafehaven.hull.ac.uk/ for more information.

BREEZE 2 has the greenlight

BREEZE 2 study is investigating a complex, non-pharmacological intervention in adults with pulmonary fibrosis and chronic breathlessness. This intervention includes the use of a handheld fan (provided to patients in this study), breathing control techniques, exercises and activities, managing thoughts about breathlessness and relaxation techniques. The study has gained greenlight this month which means it can start the process of opening it’s 15 sites across the UK.  

Other March project headlines:

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HHTU News Roundup

External funding for Study Within A Trial secured

Trial manager Matthew Northgraves has received a small grant from the University of York. This is to implement a Study Within A Trial (SWAT) in the BREEZE-2 study. A SWAT is a self-contained research study that has been embedded within a host trial with the aim of evaluating or exploring alternative ways of delivering or organising a particular trial process. The study is then replicated in a number of different trials until a decision can be made on whether the intervention works.

New HHTU equality, diversity and inclusion group formed

Within clinical trials there is ever growing awareness that there are people and communities that are underserved by research, a fact recognised by funders. In an attempt increase the inclusivity of our studies, a HHTU Equality, Diversity and Inclusion (EDI) group was formed in February. The group consists of Trial Managers Grant Constable, Amy Wilkinson and Matthew Northgraves along with HHTU Director Prof Judith Cohen and NIHR Doctoral Fellow Laura Hermann. Whilst the first official meeting was not planned until March, meetings have already been held with other supporting networks and courses attended.    

Other project headlines:

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