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.
January has been a productive month across all three STARLIT studies. The STARLIT (Salivary Test for Adrenal Response to Liquid Intranasal Tetracosactide) programme aims to develop and clinically validate a new needle-free test (the Nasacthin Test) for the diagnosis of adrenal insufficiency.
In STARLIT 1, which looked at the repeatability of blood and saliva cortisol and cortisone levels within the same individual when samples were taken close together, had the final study report submitted to the Research Ethics Committee.
The protocol paper for the follow-on study, STARLIT 2, was published in BMJ Open. The STARLIT-2 study is a healthy volunteer study which is looking to see if the new Nasacthin Test (drug given via a nasal spray and cortisol and cortisone levels measured in saliva) gives comparable results to the standard test, the Short Synacthen Test (drug given using a needle and cortisol measured in blood samples).
Finally, STARLIT 3, which will test the effectiveness of the Nasacthin Test in patients with adrenal insufficiency received sponsor regulatory green light, so is ready to open the study sites to recruitment.
The PRE-DX study had abstracts accepted for to the19th St. Gallen International Breast Cancer Conference 2025 in Austria in March and the Association of Breast Surgery (ABS) conference in May. The abstract for St Gallen is for a poster presentation and the ABS abstract is for an oral presentation and both will be the first dissemination of the study results.
2024 allowed us to reflect on the growth of the HHTU which has been open 5 years. There was no greater evidence of that growth than our attendance at International Clinical Trials Methodology Conference (ICTMC).
In 2022 we had 1 poster.
In 2024 11 posters were presented.
The 2024 posters were on various topics, including trial methodologies, participant engagement, and innovative approaches to data collection. This year six members of the HHTU were able to attend the event in Edinburgh. ICTMC is a major event for clinical trial professionals, researchers, and the public, providing an opportunity for HHTU to showcase their work. The conference offered valuable learning experiences, with keynote speeches and presentations that enhanced attendees’ research skills. It also provided a platform for networking and collaboration, and allowed attendees to gain insights into the latest developments in clinical trial technology and methodology.
In addition to ICTMC, HHTU staff have presented at several other events, both locally and internationally. Judith presented on the MOI-A Study in Budapest (October) and Bologna (June), while Mahe presented virtually at a conference in Iran (May). Mahe and Charlotte Kelly also showcased a poster at the Annual Allam Lecture in Hull (September).
Working Together
This year, two “away days” were organised, providing a valuable opportunity for teams to come together and discuss important projects and topics. They offered a chance for team members to connect and engage and work together to look at ways to improve procedures and overcome any challenges. The focus was on the Data Team and the Trial Teams, with Operations Manager Bronwen Williams emphasising the value of getting everyone in the same room despite the mix of home and office working.
In addition to these collaborative events, two leaders were recognised as “Brilliant Leaders” this year. The University’s Building Brilliant Leaders Programme is designed to help leaders understand their impact on their teams and foster inclusive environments. Trial Manager Matthew Northgraves, who is currently participating in the course, and Sarah Sumpter, who completed it this year, were the two leaders highlighted. Sarah shared that the programme helped her rethink leadership, boosting her confidence in managing people-related challenges.
As well as this, John Turgoose, a senior team member, was appointed joint chair of the UKCRC Data and Information Systems Operational Group. This appointment reflects the HHTU’s commitment to sharing experiences and collaborating to tackle challenges.
These personal achievements, combined with regular team meetings, contribute to the goal of growing together as a strong and connected team.
A Big HHTU Milestone
A big achievement to end 2024 is that the Hull Health Trials Unit are now a fully registered Clinical Trials Unit after being provisionally registered since 2019.
The UK Clinical Research Collaboration (UKCRC) full registration for clinical trials units (CTUs) is a system designed to assess and formally recognise clinical trials units (CTUs) in the UK based on their ability to deliver high-quality, efficient, and ethical clinical research. This registration is important for CTUs as it provides formal recognition of their capability to manage and deliver complex clinical trials, particularly those that involve public funding or collaborations with other research entities. Achieving UKCRC Full Registration is an indicator that a CTU is capable of managing large, complex trials with a high standard of professionalism, compliance, and research integrity. It reflects a commitment to conducting research that can impact public health and clinical practice, and often signals that a CTU is capable of working with various stakeholders, including academic institutions, hospitals, government bodies, and pharmaceutical companies.
We have no doubt that 2025 will be another year of growth with more collaboration, dissemination and achievements to come.
All at HHTU would like to wish all our colleagues and collaborators a restful Christmas Break and a very Happy New Year. The HHTU will be closed from 5pm Friday 20th December until 9am Thursday 2nd January.
On Wednesday 13th November we held our first Hull Health Unit Trial Management ‘away day’ (even though it was in the office). Since opening in 2018, the HHTU has continued to grow with the team ever expanding so this was a chance to get all the trial management team together. It was a great day of discussions and shared learning around potential recruitment and retention strategies, risk assessments and monitoring.
Operations Manager Bronwen Williams said ‘Now we are all working from home and the office, it was great to get everyone in one room (except for Mahe who joined remotely). We had a very productive meeting including training, discussions on emerging issues in clinical trials and how we might implement key trial management initiatives. It was a positive and productive day, and we have agreed to have ‘Away Days’ at least twice every year going forwards.’
HHTU Director and Trial Manager attend Networking Event
Our Director Judith Cohen and Trial Manager attended the joint Innovation, Research and Improvement System (IRIS) at Humber and North Yorkshire and NIHR ARC Yorkshire and Humber knowledge motivation networking event. It brought together in bringing together individuals from academia, the Integrated Care Board and Integrated Care Systems with the NIHR infrastructure in the region. This promoted the sharing of knowledge which is important for moving research evidence into practice and led to future collaborations to be discussed.
Centre for Addiction and Mental Health Research opens
In big news the new Centre for Addiction and Mental Health Research (CAMHR) has been launched. Our Director Judith Cohen, alongside Prof Tom Philips (who is currently Project Investigator on numerous studies at the HHTU), were successfully awarded £11 million by NIHR to set up this world leading research centre which will carry out essential research into addiction and mental health. The initial five years of research will focus on those often hidden or excluded from treatment across three core groups:
young people with substance use and mental health problems.
adults with substance use disorder and mental health problems, and
the needs of adults with alcohol-related cognitive impairments.
The HHTU’s Director Judith Cohen attended the General Assembly Meeting REMEDi4ALL in Budapest this month. REMEDi4ALL are the European Platform for Drug Repurposing and the HHTU’s MOI-A Study is a part of the REMEDi4ALL consortium.
Judith presented the progress and challenges experienced with the MOI-A study and subsequent changes to the protocol which have been made following discussions with the Drug Repurposing Development Team at REMEDi4ALL. A theme running through the event was patient centricity and there were some excellent presentation around this through the meeting. To read more about REMEDi4ALL click here and for the MOI-A study click here.
1st participants recruited in COPD Cardio Protect
COPD Cardioprotect got underway with the first three participants recruited to the study in October. COPD CardioProtect is looking at the effect of adding an inhaled steroid (budesonide) has on platelet activity and function in people with COPD to better understand the relationship between COPD and cardiovascular disease.
Information Systems Manager Organises National Meeting
John Turgoose, our Information Systems Manager recently organised the UKCRC Data and Information Systems Operational Group (DISOG) National meeting as a part of his role as the co-chair of the group. This was in Leeds and brought together data professionals from accross the country. The presentations highlighted invaluable best practices and shared insights on a wide range of data and systems-related topics.
New Trial Manager joins the team
In October we had another new starter joining the ever growing HHTU team. Grant Constable joins us from Hull University Teaching Hospitals where he worked in the Sponsorship team where he was a Quality Assurance Clinical Trials Monitor and he also has a background in the pharmaceutical industry. He is now a Trial Manager at HHTU and has started managing the BREEZE-2 and DAMPenD 2 studies.
Members of the HHTU attended the Annual Allam Lecture this month where Dr Charlotte Kelly (Chief Investigator) presented a poster for the HHTU managed DOORStep study. There was then an interesting afternoon of lectures by HYMS researchers which was rounded off with an impressive lecture by Prof Pat Price about the lobbying for a new radical NHS cancer plan and opportunities in PET based medicine. We are looking forward to next year’s Allam Lecture and hope to present more posters.
DOORStep also opened to recruitment this month. Which included the first GP practice in the intervention arm which offers a free taxi for the women to get to their breast screening appointment. You can read more about the DOORStep study here.
Charlotte with Trial Manager Mahe Haji Sadeghi at the Allam Lecture
Trial Administrator Jackie at the breast screening van
COPD Cardio Protect Open to Recruitment
COPD Cardio Protect is looking at the effect that adding an inhaled steroid (budesonide) has on platelet activity and function in people with COPD. The study has one site at Hull University Teaching Hospitals which has now opened to recruitment.
Study Recevies its Approvals
Congratulations the BREEZE 2 team on obtaining Research Ethics Committee (REC) and Health Research Authority (HRA) Approvals in September. BREEZE 2 is a randomized controlled trial of complex intervention to manage breathlessness in pulmonary fibrosis.
New Trial Manager
The HHTU are pleased to welcome a new Trial Manager to the team. Amy Wilkinson joins us from Hull University Teaching Hospitals where she worked as a trial manager in the inflammatory Bowel Disease research group. It is great to have Amy and her expertise on board and we look forward to the contributions Amy will make to research at HHTU. She has started to work on the FANfirst study which you can find out more about here.
Trial Manager Accepted onto University Programme
We are pleased to announce that Matthew Northgraves (Trial Manager) has been accepted to take part the University’s Building Brilliant Leaders Programme. This programme is 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. Our Senior Data Manager Sarah Sumpter completed the programme as a part of the last cohort and said
‘the programme has helped me rethink leadership and create clear goals for my development. I now understand people better and feel more confident in tackling challenging people related tasks.’
We wish Matt the best of luck with the programme.
DSH News Roundup
September saw the data for 2 projects arrive. HALO and PREDISPOSE HEME opened last month and the data from HALOZYME and NHS England respectively have now arrived much to the researchers delight. We look forward to seeing the outcomes of this research. You can read more about these projects in Augusts news here and learn more about the Data Safe Haven here.
ProACTIVE Work Package 2b opened this month and the data arrived from NHS England. This work package is examining the impact of Alcohol Care Teams by assessing re-admission rates, length of stay, etc. with an interrupted time series analysis using nationally available data from NHS England. The whole three-year programme of research is in full swing and is examining the clinical and cost effectiveness of Alcohol Care Teams to inform the future commissioning of these services.
We had 2 projects close this month in the DSH which were both student projects. One was Aneeqa Qureshi’s who was studying a masters in the UoH institute of Data Science and Artificial Intelligence and Modelling Centre (DAIM) and her project used AI. Deborah Chilekwa’s project Ethnic inequalities in cervical screening uptake also closed. This used data from the UK data service. We are able to provide free access to the Data Safe Haven which allows for student projects like the above to have access to the Data Safe Heven when they may not have been able to. You can learn more on our costings page or email DSH@hull.ac.uk for more information.
The Hull Health Trials Unit is responsible for the management of the University of Hull Data Safe Haven (DSH). The DSH is a trusted research environment that has the appropriate technical and information governance controls for the storage and processing of sensitive research data.
We currently have 18 projects active within the DSH, 3 of which were opened during August. We are currently enabling research across 3 of the 4 faculties at the University as well as with external collaborators based at the Hull University Teaching Hospitals (HUTH) and the York and Scarborough Teaching Hospitals NHS Foundation Trust (YSTH). This is with masters and PhD students as well as academics and clinicians.
The data being analysed in these projects is from 9 unique providers. The most common provider is NHS England. The DSH team are able to assist with applications for data and funding and have experience with NHS England, CPRD, UK Data Service amongst others. We also have 3 projects that are using the DSH for the storage and analysis of data collected during their own research study. This includes a study that is building a registry of palliative care data and another where app data was uploaded straight into the DSH for analysis.
The 3 studies that opened during August were HALO, PREDISPOSE HEME and DYNAMIC ROSE. You can find out more about these studies below:
HALO: This project is working with a team at HUTH who, under the leadership of Dr Anthony Maraveyas, are analysing the results of an international study. The study is about Thrombosis and bleeding in patients with thrombocytopenia in the HALO 109-301 trial for hyaluronan-high metastatic pancreatic ductal adenocarcinoma.
DYNAMIC ROSE: Is again working with a team at HUTH but with Dr Mike Crooks and his team. This study involves dynamic real world testing and evaluation: Implementing and evaluating the Lenus COPD Support Service for remotely managing chronic obstructive pulmonary disease (COPD) in HUTH. It is using data from HUTH and North Lincolnshire and Goole NHS Trust.
PREDISPOSE HEME: This study is using NHS England data to find out the prevalence of cirrhosis and its related complications amongst patients with hereditary haemochromatosis in England. Dr Rob Driver and his team at the YSTH are carrying out this study.
In other August news, PRE-DX reached another key point as the statistical analysis plan was signed off and all data queries were resolved allowing the study to go into data soft lock. Analysis will be completed over the remainder of 2024 with the results by early 2025.
At the start of July, it was confirmed that 10 poster abstracts had been accepted for the International Clinical Trials Methodology Conference (ICTMC) being held in Edinburgh in October 2024. Abstracts were submitted by different members the trial management team, data management team and statisticians. A few of the abstracts titles are below:
Developing an electronic safety reporting data flow in clinical trials using standard design components in an off-the-shelf cloud-hosted EDC system
Impact on participant recruitment of adding an Infographic to a Patient Information Leaflet in the MABEL trial, a study within a trial
A comparison of the characteristics and response rates of participants using electronic, postal or phone data collection for follow-up questionnaire in the PRE-DX study
This is great reflection of how far we have come in the last two years as in 2022, we only had one!
The Mabel (Morphine and BrEathLessness) Study reached some key milestones in June with the data team achieving hard lock prior to the Investigator Meeting which took place on Tuesday 25th June 2024. The study team which included individuals form all over the United Kingdom attended in person at the University of Hull and online to participate in the event which was led by Professor Miriam Johnson and Professor Marie Fallon.
At the event presentations of the study’s preliminary findings were facilitated by the trials Statisticians, Health Econometricians and Sub Study lead. They were: Sharon Tuck (Unblinded Statistician), Catriona Kerrie (Trial Statistician), Marek Atter (Health Economist), Professor Peter Hall (Trial Lead Health Economist) and Dr Mark Pearson (Sub-study lead). After each presentation there were opportunities for discussion which were very valuable.
Details of the results/findings of this study will be made available once the publications are released.
On behalf of the Mabel Study team, we would like to thank everyone for their contributions.
HHTU Director presents at patient meeting
Our Director Judith Cohen travelled to Bologna in Italy this month for the 2nd REMEDi4ALL Multi-Stakeholder Meeting. REMEDi4ALL is the wider programme our study MOI-A is funded by and its focus is the repurposing of medicines for other use. This June meeting was about Patient Centricity on Osteogenesis Imperfecta (OI) Research. Judith was able to present the current challenges the project is facing and get feedback from the patient and public involvement (PPI) members attending. Judith stated conversations with PPI members were extremely helpful in understanding their view on the issues. She recognised the need to continue engaging with the PPI to make sure they continue to be happy with any new proposals going forward in the study.
PPI is so important to research as it ensures we focus on what really matters to the research population for each study. Find more about PPI here.
Annual Toolkit Submitted
Each year the HHTU must complete the NHS England Data Security and Protection Toolkit. The DSPT is an online self-assessment tool that enables organisations to measure and publish their performance against the National Data Guardian’s ten data security standards. Our Toolkit covers both the HHTU and the Data Safe Haven.
We are required to do this so that we are able to hold NHS data as it assures we are practising good data security and that personal information is handled correctly. You can find our DSPT history here: https://www.dsptoolkit.nhs.uk/OrganisationSearch/EE133824-HHTU.
The HHTU are expanding again! We are looking to recruit two new trial managers. If you would like to join a friendly and growing team working dynamically to deliver clinical trials that will have a real impact on patient health and well-being we are keen to hear from you.
It has been a really good month for the opening of studies. Two studies, DOORStep and FanFIRST both were given the greenlight to start participant recruitment this month.
DOORStep is a Yorkshire Cancer Research funded study that is looking the effectiveness and acceptability of free door to door transport to increase the uptake of breast screening appointments in Yorkshire.
FanFIRST is for people living with COPD and high short-acting beta-agonists (SABAs) inhaler intake. It is looking at whether using an intervention which includes using a fan and providing guidance reduces their breathlessness.
Mahe and Saphsa, the trial managers, for two studies have worked hard to get them underway and we look forward to the first recruits.
Trial Manager presents at a conference
Our trial manager Mahe was invited as a keynote speaker to present at 8th National Conference on Interdisciplinary Research in Management & Medical Sciences at Tehran University in Iran which she attended virtually. She was also included on the panel discussion. This was a very exciting event for Mahe as she was graduated from Tehran University years ago!
Mahe presented the final findings of the REDUCE Cluster Randomised Controlled Trial (reviewing long term antidepressant use by careful monitoring in everyday practice) in Farsi. There is concern about inappropriate long-term antidepressant use and limited evidence for successful discontinuation strategies. This trial tested practitioner review and antidepressant tapering, combined with practitioner and patient internet support, and patient psychologist telephone support, compared to practitioner review alone. In the REDUCE study, 131 GP practices in England and Wales participated to recruit 330 patients on antidepressants who were willing to try supported discontinuation of treatment.
MOI-A recruits it’s first participant
It has been an excellent month for Mahe who also had her first recruit to MOI-A which she is also a trial manager for.
MOI-A is for patients with the rare disease Osteogenesis Imperfecta which causes bone fragility and it is hoped that it will establish the effective dose of losartan that will reduce bone turnover in these patients. All UK sites are now open and it is hoped that the Italian sites will be able to open at the end of the Summer.
John becomes Chair of UKCRC group
And finally, we are delighted to report that a member of our senior team, John Turgoose has been appointed joint chair of the UKCRC Data and Information Systems Operational Group. The UKCRC (United Kingdom Clinical Research Collaboration) is a network of over 50 academic clinical trials units across the country. John is “honoured to be given the opportunity to chair the operation group. Given the rapidly changing and challenging landscape for academic CTUs, working together has never been more important.”
All at HHTU congratulate John on this appointment.
