HHTU 2024 Reflection

Sharing our Research

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.

HHTU News Roundup

First Trial Management ‘Away Day’

On Wednesday 13^th 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.

HHTU News Roundup

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.

To find out more about CAMHR please visit their webpage here: https://www.hull.ac.uk/work-with-us/research/groups/centre-for-addiction-and-mental-health-research.

HHTU Director presents in Budapest

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.

More information can be found on the project page:
https://hhtu.hull.ac.uk/copd-cardio-protect/   

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.

HHTU News Roundup

DOORStep News

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.

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.

HHTU News Roundup

3 new projects open in the Data Safe Haven

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.

To learn more about the Data Safe Haven please visit the website. https://datasafehaven.hull.ac.uk/,

PRE-DX moves towards analysis

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.

HHTU News Roundup

10 ICTMC Abstracts Accepted!

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 2022 poster can be found here:
https://hhtu.box.com/s/qkhe1zqyu0w9esg2iu85ydytdrixssvg

HHTU News Roundup

MABEL Investigator Meeting

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 25^th 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.

HHTU News Roundup

We are recruiting 2 Trial Managers!

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.

Full job details are available here: https://jobs.hull.ac.uk/Vacancy.aspx?ref=UOH-TA-0191

2 studies get greenlight

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.

HHTU News Roundup

STARLIT 3 has received REC approval

The third and final stage of the 3-stage STARLIT programme, STARLIT 3, has received REC approval. STARLIT is aiming to develop ways to diagnose adrenal insufficiency by measuring cortisol in saliva samples which will lead to needle-free testing with STARLIT 3 comparing the effectiveness of the blood test and needle free test in patients with adrenal insufficiency.

The first stage, STARLIT 1 looked at whether there are any differences in blood and saliva cortisol levels in the same individual when the samples are taken close together. The second stage within the programme which is currently recruiting now, is comparing the blood sample test to the needle-free test in healthy adults and children.

It is great to see the final stage progressing and recruitment for STARLIT 3 is hoped to start at the end of June, start of July. Further information about STARLIT 2 and how you can potentially be involve can be found in the participant information sheets here.

CANFit recruited their first patient

Our Yorkshire Cancer Research funded study, CANFit, recruited it’s first participant from the Hull site.

This study, lead by Dr Cindy Forbes, is creating personalised home-based exercise programmes with the support of exercise professionals for patients with cancer in Yorkshire and beyond. This will be compared against standard NHS care. Participants will be from either lung, breast of bowel cancer populations The team are currently working hard liasing with the cancer teams at site, to recruit more participants as well as open more sites. Any NHS sites interested in being a trial site should contact Trial Manager Alex Bullock (alex.bullock@hyms.ac.uk) for further details.  

RECORD-HF paper published

The HHTU’s Director and the Information Systems Manager, Judith and John, have both been listed as authors on Dr Joe Cuthberts latest paper ‘Outcomes in patients treated with loop diuretics without a diagnosis of heart failure: a retrospective cohort study’ which was recently published in the journal HEART.

Joe Cuthbert is a Senior Lecturer at Hull York Medical School and an honorary consultant Cardiologist at Hull University Teaching Hospitals. He used the University of Hull Data Safe Haven, which the HHTU manages, to analyse data from the Clinical Practice Research Datalink. This allowed Joe to analyse 5 years worth of data which totalled nearly 200,000 patients.

His aim was to define the links between loop diuretic prescriptions in patients without a diagnosis with heart failure and heart failure related events. The outcome of his work was that patients prescribed loop diurectics in the community who do not have a diagnosis of Heart Failure have very similar outcomes to patients with Heart Failure.

You can find more about the Data Safe Haven here and read Joe’s paper here.

LIPS poster presented

The preliminary results from one of our first studies, the Leukaemia in Pregnancy Study were presented as an e-poster at the BSH Annual Scientific Meeting 2024 held in Liverpool between 28-30 April 2024. It is hoped that the full results paper will be published later this year. You can read the poster here.

Numerous abstracts submitted to ICTMC 2024

Various members from the trial management and data teams submitted abstracts to the International Clinical Trial Methodology Conference due to be held in Edinburgh in October. The increased number of abstracts submitted, when comparing to ICTMC 2022 where we had two submissions, is a great reflection of the growth the HHTU continues to make.

Now for the nervous wait until 1^st July when the outcome notification to authors is expected!!!!   

HHTU News Roundup

MOI-A team members attend international conference 

The MOI-A demonstrator (10.4) project within the REMEDi4ALL Consortium is assessing the repurposing of losartan in adults and older adolescents with osteogenesis imperfecta, an inherited form of bone fragility, caused in the majority of cases by mutations in one of the two genes encoding type I collagen. 

Judith Cohen (HHTU Director) and Mahe Haji Sadeghi (Trial Manager for MOI-A) were invited to attend iDR24 the first international Drug Repurposing Conference which was at the start of March in Barcelona The conference was around Bridging Boundaries: Innovating, Connecting & Reshaping Drug Repurposing.  

Judith and Mahe presented a poster at the conference to report on the challenges that have arisen during the set- up of the study with the expectation that future studies will be able to proceed more swiftly. 

This was a global event and great opportunity to hear and meet key leaders from the research and patient communities, funders, regulators and the private sector from Europe and beyond. They both managed to speak to others from around the world to explore innovative approaches, discuss our challenges, share best practices, and further work towards a healthier future for patients and society. 

More exciting news from MOI-A! 

The MOI-A study now got the sponsor Greenlight for all 3 sites in the UK with our 3rd site at Sheffield Teaching Hospital granted the Greenlight and opening to recruitment in March. 

PRE-DX Protocol paper published in PlosOne

The PRE-DX protocol paper has now been published in PlosOne. The study is aiming to assess the impact on patient management if the Oncotype DX test is requested on a biopsy sample taken at the time of diagnosis as opposed to a sample obtained during surgery. The availability of this result earlier in the clinical care pathway may streamline the pathway, reducing the time to start adjuvant cancer therapy, reducing the demand on health care services, and improving patient experience. The results for the study are expected to be available by the end of the year.   

Click here to view the paper.

The TRANSFORM Showcase  

Members of the HHTU attended the TRANSFORM Showcase on the 21^st March. THis event was to present a lot, but not all, of the research that the £4.9 million TRANSFORMing Cancer Outcomes in Yorkshire programme has enabled as it nears it’s end. This programme was funded by Yorkshire Cancer Research with it’s aim to tackle the cancer inequalities that exist in Yorkshire esepcially Hull. The presentation sessions were split into Cancer Screening, Activity and Cancer, Neglected Symptoms, Cancer Experiences and Underserved Communities with lots of posters and multimedia presentations (such as games, interactive maps, videos) to view over the lunch period. 

10 out of the 18 presenations also had a link to the HHTU and the Data Safe Haven (which HHTU Manages). Whether this was because the study was managed by the HHTU such as CANfit and DOORStep presented by Dr Cindy Forbes and Dr Charlotte Kelly respectively. Or that we provided a data system such as secure box storage like for Dr Gillian Jacksons DAMPenD project or Dr Micky Kerr’s PRIORITY study. Or the data for the study was stored in the Data Safe Haven allowing them to analyse very large NHS data sets such as Dr Arwa Abdel-Aal and Dr Benjamin Pickwell-Smiths PhD projects looking into cancer inequalities. It was a really rewarding day to see the details and results of the important and interesting research the HHTU has played a part in.  

A particularly excellent presentation was about the public involvement community for cancer research which at Hull is the PPI network, Involve Hull. This was presented by Helen Roberts (Patient and Public Involvement Co-ordinator) and Involve Hull member Helen Baker. It really showed the importance and value of a PPI network not only for the instition and research but also for the PPI members that take part.     

It was an excellent and inspiriational day for all involved.