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.  

HHTU News Roundup

MABEL one step closer!

Exciting news regarding the MABEL Study. All Actigraphs reports where calculated and received by each site. All on site monitoring visits have been completed and the team/sites have successfully closed all the open queries in REDCap this February 2024. We are at present entering Soft Lock Phase and Data Analysis is to begin shortly, with the plan to have some preliminary results to present at the Investigator Meeting in June 2024 to which we are expecting representatives from all participating sites either in person or via video link. HHTU would like to say thank you to all sites involved to get us to this point, this marathon is not over but we know that the finish line is in the horizon.     

STARLIT-2 recruits it’s first participant!

The STARLIT-2 study opened at two sites recently and has now successfully recruited it’s first participant! STARLIT is a 3-stage programme that aims to develop ways to diagnose adrenal insufficiency by measuring cortisol in saliva samples which will lead to needle-free testing. The second stage within the STARLIT programme will be comparing the blood sample test to the needle-free test in healthy adults and children. This first participant marks a great milestone for the study. Congratulation STARLIT team!

DOORstep study recevied several approvals

Congratulations the DOORStep team on obtaining Research Ethics Committee (REC), Confidentiality Advisory Group (CAG), Research & Evaluation Coordinator Advisory Committee (RIDAC) & Health Research Authority (HRA) Approvals in February. DOORStep is a cluster randomized GP feasibility trial funded by Yorkshire Cancer Research and will assess whether offering free, bookable, door-to-door transport to and from breast cancer screening appointments could increase the number of women attending screening.

HHTU News Roundup

2024 has got off to a busy start. Here is a roundup of this months news.

STARLIT-2 open to recruitment!

Congratulations to the STARLIT team on their recent achievement – STARLIT-2 first site is now open to recruitment! STARLIT is a 3-stage programme that aims to develop ways to diagnose adrenal insufficiency by measuring cortisol in saliva samples which will lead to needle-free testing. The second study within STARLIT will be comparing the blood sample test to the needle-free test in healthy adults and children. It has been a long process, but the hard work in these initial stages has paid off and the focus now shifts to the next stage in the study life cycle.

MOI-A Study open to recruitment!

There was more success for our studies with the MOI-A Study also opening to recruitment! This study is working with sites in both the UK and Italy who will be looking at whether the use of the drug losartan will reduce bone turnover in older adolescents and adults with Osteogenesis imperfecta, bone fragility.

Sheffield Children’s NHS Hospital Foundation Trust and Royal National Orthopaedic Hospital successfully obtained sponsor Greenlight and have started to identify and shortlist the participants. The 3^rd site in the UK; Sheffield Teaching Hospitals NHS Foundation Trust will be open to recruit shortly. The Italian sites will open later this year.

ProACTIVE WP-2A has its first recruit

Proactive is a study made up of several work packages which are examining the clinical and cost effectiveness of Alcohol Care Teams to inform the future commissioning of these services.

Work Package 2a recently opened and successfully recruited it’s first patient! The purpose of this work package is to assess the effectiveness of alcohol care teams by comparing the outcomes of people with alcohol-related problems who attended hospitals with alcohol care teams to those who attended hospitals with no alcohol care team. Research assistants are going into 6 different hospitals across the country where they will carry out questionnaires with patients that have alcohol related problems. This is a great first step for this study and with more research assistants to hire and sites to open, this number is the first step to success!!

Quality Assurance Manager started

Our SDM accepted onto Building Brilliant Leaders programme

Our Senior Data Manager Sarah Sumpter was accepted onto 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. At the end of January Sarah and John Turgoose (her line manager) attended the launch event at the University. At this event the leaders from across the University and their sponsors gathered to share their hopes and ambitions for the project, listened to members of our ULT panel as well as talks from Deputy Vice-Chancellor, Professor Kevin Kerrigan and Chief People Officer, Sarah Wilson.

We wish Sarah the best of luck with the program!

HHTU News Roundup

PRE-DX closes to recruitment

PRE-DX closed to recruitment a week early with a final recruitment total of 341 participants which an over recruitment of was 103% of the original target. This was an impressive achievement at a time when many trials struggle to recruit. The study is expected to close next year.

MABEL closes to recruitment

The NIHR Health Technology Assessment funded MABEL Trial closed to recruitment with 148 participants, which was 94% of the original recruitment target. Due to fewer than expected participants withdrawing from the trial, this is expected to be enough for us to answer whether low dose morphine capsules taken twice a day improves for chronic breathlessness and improves daily activity. After the significant delays caused by the pandemic, this was a significant landmark in this important trial and huge thanks goes to all our sites.

HHTU News Roundup

PRETZCEL’s First Recruits

PRETZCEL have recruited their first two participants to the study! PRETZCEL is looking at the use of a new imaging agent in PET-CT scans. This imaging agent attaches itself to a type of immune cell called a CD-8+ T-cell. The imaging agent then allows us to track the behaviour of the CD8+ T cells that play an important role in killing cancer cells. This may help in the development of new drugs that target the immune system and allow doctors to tailor the treatment of patients with cancer. The hard work of the site team at Castle Hill as well as Martina and Bronwen at HHTU have meant the study has now got underway.

HYMS Away Day

On the 18th of October members of HHTU attended the Hull York Medical School Away Day. The event had a global theme and provided an opportunity for those in attendance to consider how HYMS might realise the Strategy 2021-26 and specifically the aim of practising in a global world and building international connections. There was an interesting and interactive presentation by Professor Helen Elsey to challenge our perceptions of global challenges as well as plenty of time to network and meet other members of HYMS.

Mahe presented an ICAHR Seminar

Our Trial Manager Mahe presented at an ICAHR Seminar this month where she introduced the findings of the REDUCE Study (reviewing long term antidepressant use by careful monitoring in everyday practice). This was a study that compared practitioner review and antidepressant tapering alone, with the addition of practitioner and patient Internet support and patient psychologist telephone support. This study was to address a concern about inappropriate long-term antidepressant use in high-income countries, and that there is a limited evidence for successful discontinuation strategies. 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.

DISOG Conference

This month, some of our data team members attended in the UKCRC Data and Information Systems Operational Group (DISOG) National meeting. This event brought together approximately 70 data professionals representing registered CTUs from across the UK. The presentations featured invaluable best practices and shared experiences across an array of data and systems-related topics. An exciting highlight of the event was the announcement introducing our Information and Systems Manager, John Turgoose, as the newly appointed co-chair for the group.

ProACTIVE Work Package 1a Closed

ProACTIVE is a 3 year integrated mixed methods programme of research examining the clinical and cost effectiveness of Alcohol Care Teams to inform the future commissioning of these services. Alcohol-related hospital admissions continue to rise, with estimates that 10% of patients admitted to acute hospitals may be alcohol dependent (AD). Yet, there remains considerable variation in provision of Alcohol Care Teams (ACTs) in England, and a limited evidence base for understanding their clinical effectiveness.

Work Package 1a was a survey built by the Data Management team at HHTU, that will generate a detailed profile of ACT services and activities currently operating, this will be summarised to define currently delivered components of ACTs and the different patient groups with which they work. The ProACTIVE researchers hard work resulted in a very high response rate. The data is currently being cleaned ready for downloading for the ProACTIVE team to analyse.

HHTU News Roundup

New Summer Staff

The HHTU had 4 members of staff in 2019 and now we are a team of 22! This summer alone we welcomed 4 new members of staff. Each one comes from a different work background and brings a wealth of different knowledge and experiences. Our 4 new summer starters are two Data Managers and two Trial Coordinators.

Laura and Beccy are our two new Data Managers who will be building the databases for our studies on our electronic data capture system along with the testing and reporting that goes alongside this. Laura has joined us from a similar role at Newcastle Clinical Trials Unit and Beccy also has a data management background but has moved from a higher education provider in Hull. 

Amy and Charlotte are our two new Trials Coordinators who will be supporting our Trial Managers with the set up, running and monitoring of our studies. Charlotte has a nursing background and has moved from a research nurse role in the Rheumatology team within Hull University Teaching Hospitals. Amy was a senior clinical trials assistant in the Research and Innovation department at St James’ Hospital in Leeds.

HHTU have been so pleased to welcome them to the team and their experiences have already been proven to be extremely useful and will only strengthen the team.

In future recruitment news, January will see us welcoming a much needed Quality Assurance Manager. We expect that more staff will be needed in the not too distant future so keep your eye out on the University of Hull job pages for vacancies or email hhtuenquries@hyms.ac.uk to enquire.

STARLIT received MHRA Approval

After a long wait STARLIT 2 has now received MHRA approval! STARLIT is a 3 stage programme that aims to develop ways to diagnose adrenal insufficiency by measuring cortisol in saliva samples which will lead to needle-free testing. The second study within STARLIT will be comparing the blood sample test to the needle-free test in healthy adults and children. The HHTU team are now beavering away to get the study open for recruitment.