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.

HHTU News Roundup

HHTU Director made Professor

Judith’s hard work and knowledge successfully and continually brings in more and more research to the University. As well as this she leads the module Bench to Bedside II, Clinical Trials in the Msc Pharmacology and Drug Development and is a PhD supervisor.

The process to become a professor is a huge undertaking in itself and a huge achievement. All the staff at the Hull Health Trials Unit are very proud of our Director.

Other Promotions

As well as the HHTU Director two of our close collaborators were also promoted. Dr Maureen Twiddy was promoted to Reader and Dr Micheal Crooks to Professor. Maureen is the Methods Hub Lead and the HHTU work closely with her for many of our studies. Mike is the principal investigator for many of our respiratory studies. Congratulations to them both.

MABEL Protocol Paper Published

The protocol paper for the NIHR Health Technology Assessment MABEL Trial has been published in the ERJ open (click here to view it). Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7 days) administration. MABEL is looking to evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness.

PRE-DX at 3/4 Recruitment

The PRE-DX Study‘s aim is to recruit 330 patients newly diagnosed with breast cancer to participate in the study from 20 different hospitals around the UK. Recruitment will end in November 2023 so reaching the 3/4 recruitment stage is a big step to reaching the goal.

MOI-A received MHRA Approval

The MOI-A study has received MHRA approval this month. The MOI-A Study is to establish the effective dose of losartan in older adolescents and adults who have Osteogensis Imperfecta. The research is funded by the United Kingdom Research and Innovation (UKRI) as part of the REMEDI4ALL EU Horizon platform and will be working with sites in both the UK and Italy.