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Fitness app could transform care of rheumatoid arthritis patients

Written by Louise Stanley on . Posted in Clinical trials, Inflammation and chronic disease.

Researchers at BHP members Sandwell and West Birmingham NHS Trust and the University of Birmingham aim to transform the care of rheumatoid arthritis (RA) patients by developing an app which links to the Fitbit – a popular activity tracker.

The rheumatology medical team and researchers are leading the groundbreaking clinical trial to create the app which they hope will ease the pain of patients suffering from the crippling disease and provide extra support.

It’s called MISSION-RA which stands for MovIng to Support Sustained Improvement of Outcomes iN Rheumatoid Arthritis.

Sally Fenton, Chief Investigator for the study, said: “The app will be specifically designed for and by people with RA.

“This will be done in two ways. Firstly, a series of interviews, co-design studies and workshops will be carried out to develop the app. Then, artificial intelligence will be used within the app to provide personalised support for people living with RA, based on symptoms such as pain, fatigue and mobility. It is expected the app will be available to download for free so it can be used on a Fitbit in the future.”

RA leads to inflammation of the joints and surrounding tissues which causes flare ups – this is when symptoms become worse. One of the ways to help ease these episodes of pain can be through exercise, physiotherapy and occupational therapy.

Dr Sangeetha Baskar, Clinical Specialty Lead for Rheumatology and Principal Investigator for MISSION-RA explained: “Rheumatoid arthritis is an extremely painful, tiring, psychological and physically debilitating disease. Patients face countless challenges while doing basic daily activities such as dressing, cooking and walking and often become dependent on family members to perform some of their daily tasks. Through this innovative study and the mobile app, we are hoping to help patients increase their physical activity tailored for them and improve their quality of life.”

The first patient from the Trust has already been recruited into the study.

Ana Duarte, Clinical Research Practitioner (CRP) and also Associate Principal Investigator, said: “Overall, the MISSION-RA study has overcome our initial expectations. Patients are very keen and have enjoyed their experience so far. This has also been a great opportunity for the study staff which has led to progression in their careers. Most importantly, this we hope will place SWB’s R&D department and rheumatology team as international leaders in healthcare AI and machine learning.”

MISSION-RA is being delivered in partnership with the National Institute for Health and Care Research (NIHR) and National Rheumatoid Arthritis Society (NRAS).

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Behind the scenes – meet the ROH research team

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Experimental medicine.

Written for BHP by Ellie Keeling, Lead Research Nurse at the Royal Orthopaedic Hospital

Birmingham is a major research hub with a thriving collaborative ecosystem convened by Birmingham Health Partners. Within this alliance, the Royal Orthopaedic Hospital (ROH) is leading the way in orthopaedic research, conducting clinical trials, observational studies, and laboratory research. Our work focuses on enhancing physiotherapy rehabilitation, developing therapies for bone tissue regeneration, and creating pharmaceutical treatments to reduce invasive surgeries and speed up recovery. ROH’s research aims to improve patient care, facilitate early diagnosis, support new drug development, and offer alternative treatments, consistently contributing new findings to the field.

The majority of this work happens behind the scenes. And the roles that make up this team are varied. They include our lab manager who oversees the management of the Dubrowsky Lab; research nurses; a research tissue bank co-ordinator; study co-ordinators; assistant clinical research practitioners; data managers; and a healthcare technician.

Research nurses play a vital role in delivering clinical research, guiding the patient as they go through the clinical research process and ultimately improving patient care and treatment pathways. It’s an incredibly diverse role, from recruiting patients for studies to collecting and tracking samples, and developing pathways to improve the delivery of trials. Because many clinical trials run over the course of several years, research nurses get to work with the same patients regularly and are able to build up a rapport with them.

Our research tissue bank co-ordinator manages our research tissue bank, which was established over thirty years ago and contains the world’s largest archive of frozen bone tumour samples – currently numbering 32,000 – including all orthopaedic malignancies as well as other benign and non-tumour tissue types. The research tissue bank is used by researchers across the globe who need access to bone and tissue samples that they can’t get elsewhere, with the samples supporting clinical projects to better understand cancers like chondrosarcomas (cancer of the cartilage cells) or develop new treatments for primary bone cancer.

The team is involved in a number of clinical trials, including the BASIS study and the RACER Hip and Knee studies. We are one of the main recruiting centres for the BASIS study, which is trying to find out which type of back brace is best for treating children and young people with scoliosis. The RACER Hip and Knee studies are exploring clinical effectiveness of robotic assisted hip and knee replacement. Pivotal to the success of these studies is patient recruitment – working closely with patients and recruiting them onto these clinical trials with empathy. Our assistant clinical research practitioners (ACRPs) are critical here, as this research couldn’t happen without the generosity of patient donations and their time. In this role, ACRPs work closely with patients to explain what research we are doing, explore how the patient could potentially participate in this research and support them through the process.

It’s essential that patient donations are viable and there are several steps required to ensure this. The role of the healthcare technician is a rare role, but a key one at ROH as it enables a clear and consistent pathway for the effective collection and packaging of patient bone and tissue samples.

Finally, our data managers keep all this work running smoothly by supporting the team with the collection and storing of patient data. This support helps our researchers identify what patient data could support new and existing clinical research as well as retrospective data-led research, all the while ensuring compliance and confidentiality.

While many research roles, especially in hospitals, are perceived as being behind the scenes, they are incredibly important bringing unique skills and knowledge and their contribution is crucial in making breakthroughs that can improve lives.

For more information on The Royal Orthopaedic Hospital’s research activities, visit Royal Orthopaedic Hospital – Research (roh.nhs.uk).

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Clinical trials programme kicks off with pulse survey

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials.

As part of our ‘Reducing Bureaucracy in Clinical Trials’ programme, Birmingham Health Partners is seeking the views of research-active colleagues from across the research partnership to help inform our strategy and ensure patients get access to clinical trials, quicker.

BHP’s Clinical Trials working group – established in 2018 by Professor Pam Kearns – has highlighted a number of opportunities to increase efficiency and allow us to build on the growing national momentum to improve clinical trials delivery. Now, with the ultimate aim of reducing the overall time taken to set up academic clinical trials led within BHP, we are working to improve the experience of colleagues facilitating and navigating the set-up process and welcome views from Chief and Principal Investigators, trial management teams, R&D and support staff.

Senior Programme Lead Amy Smith said: “Input from colleagues across the BHP research community will be vital for our programme. By understanding your current experiences, we’ll be able to identify areas for improvement and ensure the right support is in place at every stage of the process.”

Sir David Nicholson, BHP board member and sponsor of the project, said: “This pivotal initiative is based on BHP’s shared belief that all patients should have the opportunity to take part in research, and the knowledge that research-active healthcare organisations perform better. We are all committed to working together to reduce bureaucracy and duplication of effort in clinical trials through this project, which will offer patients access to trials sooner and ensure innovations reach the clinic more quickly. The fantastic diversity of our regional population also means that our research, and the commercial innovations which result from it, will be applicable nationally and globally.”

The survey can be accessed at the following link – Reducing Bureaucracy Programme: Experience Survey – and is open to employees of any BHP member organisation involved in research delivery. The deadline for responses is Monday 12 August 2024.

The programme has been established to respond the challenges identified in recent reviews by Professor Adam Tickell and Lord O’Shaughnessy.

World-first colorectal cancer vaccine trial treats first UK patient in Birmingham

Written by Louise Stanley on . Posted in Cancer outcomes, Clinical trials, Experimental medicine.

The Queen Elizabeth Hospital Birmingham (QEHB), operated by BHP founder-member University Hospitals Birmingham NHS Foundation Trust, has treated its first patient in England with a personalised vaccine against their bowel cancer, in a clinical trial which is part of NHS England’s new Cancer Vaccine Launch Pad (CVLP).

In a national first, father-of-four Elliot Pfebve received the developmental jab within the Clinical Research Facility at QEHB, one of several sites taking part in the colorectal cancer vaccine trial sponsored by BioNTech SE.

The trial is one of several that will be taking place in NHS trusts across the country to treat different types of cancer. Thousands more patients are expected to benefit from NHS England’s new CVLP, which will enable those wanting to participate in clinical trials to be fast-tracked to one of the nearest participating hospitals.

Patients who agree to take part have a sample of their cancer tissue and a blood test taken. If they meet a clinical trial’s eligibility criteria, they can be referred to their nearest participating NHS site, meaning patients from hospitals across the country will find it easier than ever to take part in groundbreaking research.

The investigational cancer vaccines evaluated in the colorectal cancer trial are based on mRNA – the same technology used for the Pfizer-BioNTech COVID-19 vaccine – and are created by analysing a patient’s tumour to identify mutations specific to their own cancer. Using this information, medics then create an experimental individualised cancer vaccine.

The developmental vaccines are designed to induce an immune response that may prevent cancer from returning after surgery on the primary tumour, by stimulating the patient’s immune system to specifically recognise and potentially destroy any remaining cancer cells.

The investigational cancer vaccines being jointly developed by biopharmaceutical companies BioNTech and Genentech, a member of the Roche Group, are still undergoing trials and have not yet been approved by regulators.

Higher-education lecturer Elliot, 55, had no cancer symptoms and was diagnosed through a routine health check with his GP.

A CT scan and a colonoscopy confirmed he had colon cancer and Eliott had surgery to remove the tumour and 30cm of his large intestine. He was then referred to the QEHB for initial rounds of chemotherapy and to take part in a clinical trial.

Eliott said: “Taking part in this trial tallies with my profession as a lecturer, and as a community-centred person. I want to impact other people’s lives positively and help them realise their potential.

“Through the potential of this trial, if it is successful, it may help thousands, if not millions of people, so they can have hope, and may not experience all I have gone through. I hope this will help other people.”

Thirty hospitals in England are already signed up to the pioneering Cancer Vaccine Launch Pad – one of the biggest projects of its kind in the world – with more sites joining the platform over the coming months.

The scheme aims to expand and work with a range of partners in the pharmaceutical industry to include patients across many cancer types who could potentially join a vaccine trial, such as those with pancreatic and lung cancer.

Principal Investigator for the trial at QEHB, Consultant Clinical Oncologist, Dr Victoria Kunene, said: “The investigational cancer vaccines are based on mRNA and are created by analysing a patient’s tumour to identify mutations specific to their own cancer. Using this information, we can create an individualised investigational cancer vaccine, but it is too early yet to say if these will be successful, though we are extremely hopeful.

“Based on the limited data we currently have of the in-body response to the vaccine, this could prove to be a significant and positive development for patients, but more data is yet needed and we continue to recruit suitable patients to the trial to establish this further.”

Amanda Pritchard, NHS chief executive, said: “Seeing Elliot receive his first treatment as part of the Cancer Vaccine Launch Pad is a landmark moment for patients and the health service as we seek to develop better and more effective ways to stop this disease. 

“Thanks to advances in care and treatment, cancer survival is at an all-time high in this country, but these vaccine trials could one day offer us a way of vaccinating people against their own cancer to help save more lives.

“The NHS is in a unique position to deliver this kind of world-leading research at size and scale, and as more of these trials get up and running at hospitals across the country, our national match-making service will ensure as many eligible patients as possible get the opportunity to access them.”

Trials have already enlisted dozens of patients, although the majority of participants are expected to be enrolled from 2026 onwards.

Professor Peter Johnson, NHS national clinical director for cancer at the NHS said: “We know that even after a successful operation, cancers can sometimes return because a few cancer cells are left in the body, but using a vaccine to target those remaining cells may be a way to stop this happening.

“Access to clinical trials could provide another option for patients and their families, and I’m delighted that through our national launch pad we will be widening the opportunities to be part of these trials for many more people, with thousands of patients expected to be recruited in the next year.”

Executive Director of Research and Innovation at Cancer Research UK, Iain Foulkes, said: “It’s incredibly exciting that patients in England are beginning to access personalised cancer vaccines for bowel cancer.

“This technology pioneers the use of mRNA-based vaccines to sensitise people’s immune system and in turn detect and target cancer at its earliest stages. Clinical trials like this are vital in helping more people live longer, better lives, free from the fear of cancer. If successful, the vaccine will be a game changer in preventing the onset or return of bowel cancer.”

Last year, the Government signed an agreement with BioNTech to provide up to 10,000 patients with precision cancer immunotherapies by 2030.

BioNTech has already begun conducting clinical trials in the UK, and the NHS launch pad is helping to accelerate the identification of eligible patients for those trials in England.

The vaccines being tested as part of the trials aim to help patients with different types of cancer and, if successfully developed, researched and approved, cancer vaccines could become part of standard care.

The NHS is working in partnership with Genomics England on the launch pad, with work already helping patients access the latest testing technologies and ensures they are given more targeted precision treatments for their cancer.

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E-MOTIVE wins prestigious Trial of the Year Award

Written by Louise Stanley on . Posted in Clinical trials, Health inequalities, Maternal health.

The landmark E-MOTIVE study, led by University of Birmingham researchers and coordinated by the Birmingham Clinical Trials Unit, as been awarded ‘David Sackett Trial of the Year Award’ by the Society of Clinical Trials, recognising the importance of the findings and the potential impact as the simple, low-cost approach is rolled out around the world, dramatically improving maternal health across the globe. The trial tested a package of low-cost interventions that resulted in a 60% reduction in heavy bleeding following childbirth.

Each year the award goes to a randomized, controlled trial published in the previous calendar year that is considered to improve the lot of humankind and provide the basis for substantial, beneficial change in healthcare, amongst other criteria.

“This has been the largest set of nominations for the Trial of the Year Award in all my time on the committee. We received numerous nominations for worthy trials, from around the world and across a large number of clinical disciplines – including obstetrics, emergency medicine, infectious disease, and cancer. We had a challenging time as a committee to choose a winner” said Andrew Cook, Chair of the SCT David Sackett Trial of the Year Committee.

Postpartum haemorrhage (PPH), or severe bleeding after birth, is the leading cause of maternal deaths worldwide. It affects an estimated 14 million women each year and results in around 70 000 deaths – mostly in low and middle-income countries – equivalent to 1 death every 6 minutes. The E-MOTIVE study found that objectively measuring blood loss using a simple, low-cost collection device called a ‘drape’ and bundling together WHO-recommended treatments – rather than offering them sequentially – reduced severe bleeding by 60%, and women were less likely to lose their life.

Dr Adam Devall collected the award, on behalf of the E-MOTIVE team, from the Society of Clinical Trials 45th Annual Meeting, in Boston, USA, and said: “I’m honoured to accept the Trial of the Year Award on behalf of the E-MOTIVE project. E-MOTIVE was a huge international team effort, and this award speaks to the dedication of teams at each of our 80+ sites. More high-quality clinical trial evidence is desperately needed for pregnancy and maternal health so we’re delighted to receive this recognition of our work and the impact it will have on deaths from PPH.”

Professor Arri Coomarasamy, who led the E-MOTIVE trial and is the Co-Director of the WHO Collaborating Centre on Global Women’s Health at the University of Birmingham said: “This new approach to treating postpartum haemorrhage could radically improve women’s chances of surviving childbirth globally, helping them get the treatment they need when they need it”.

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Birmingham Health Partners announces theme leads to drive strategy

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Health inequalities.

The second city’s clinical-academic alliance, Birmingham Health Partners, has appointed three strategic theme leads to support the implementation of its new five-year mission: to work together, transforming Birmingham’s healthcare through high impact innovation.

Taking the new role of Health Inequalities Lead, Dr Joht Singh Chandan is a Clinical Associate Professor in Public Health at the University of Birmingham where his research focuses on identifying and addressing health inequalities – with a particular interest in abuse and violence prevention inspired by many years of working as a voluntary police officer.

As the UK’s third-poorest city, with a diverse ethnic profile and socioeconomic demographics, Birmingham experiences significant health disparities. Joht will develop a detailed action plan for improving population health in the city, underpinned by his experience of issues that impact widely on health and wellbeing; factors that prevent early detection; and barriers to accessing healthcare.

Joht said: “We shouldn’t see reducing health inequality as just the responsibility of public health bodies. The determinants of inequality are so interlinked that not only can we not tackle issues in isolation, we can’t tackle them as one institution. Working across the partnership and linking health data platforms, we’ll be able to work in a much more representative and inclusive way to improve physical and mental health outcomes for our local communities.”

Tasked with optimising data integration across the partnership, Professor Simon Ball has been appointed Academic Lead for Data. A Consultant Nephrologist, Simon has had various roles in developing electronic health care records and using data to improve patient care and support research. His other roles currently include Associate Director for the Midlands Health Data Research UK and Senior Responsible Officer for the West Midlands Secure Data Environment (WMSDE).

Simon said: “NHS Trusts in Birmingham were among the first to adopt electronic health records systems, meaning we have access to a wealth of data – including blood tests, scans and biopsies – spanning several decades. This can provide valuable insight into an array of diseases, health conditions and care pathways – but only if it is integrated. Working together, BHP and the WMSDE can ensure our data is analysed, learnt from and used to optimise healthcare across our region.”

Leading the ‘Reducing Bureaucracy in Clinical Trials’ programme is Amy Smith, an experienced Senior Programme Lead with considerable experience in clinical trials across multiple BHP NHS Trusts and NIHR infrastructure. The programme responds to the challenges identified by Professor Adam Tickell and Lord O’Shaughnessy, ensuring patients in Birmingham get access to clinical trials more quickly. 

Amy said: “I am very proud to be leading this exciting project which showcases BHP as a leader in clinical trials.  Through trust, transparency, and collaboration we will harness the extensive knowledge and expertise within BHP, delivering improved setup times. Ultimately our aim is to make trials accessible to a diverse range of patients, quicker – increasing our attractiveness to funders and industry partners.”