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Author: Louise Stanley

Birmingham researchers receive prestigious NIHR award

Written by Louise Stanley on . Posted in Birmingham Health Partners.

Professors Melanie Calvert and Richard Riley – both of BHP founder-member the University of Birmingham – have been recognised with a National Institute for Health and Care Research (NIHR) Senior Investigator Award.

Melanie Calvert – Director of the Centre for Patient Reported Outcomes Research and Professor of Outcomes Methodology – has been reappointed NIHR Senior Investigator for a second term and said: “I am delighted and honoured to receive this prestigious award for a second term. It is important recognition, not only of my work, but that of my brilliant team at the University of Birmingham, our international collaborators and wonderful patient partners. I look forward to providing senior leadership within the NIHR and building capacity for patient centred research.”

Melanie leads the Patient-reported Outcomes research theme at the NIHR Birmingham Biomedical Research Centre (BRC) and has led international initiatives to improve the design, analysis and reporting of patient-reported outcomes (PROs) in clinical trials and works with the Health Research Authority to improve ethical and inclusive PRO collection. Through global leadership and collaboration she has engaged patients and professionals, developing international guidelines which informed European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidance and are used by pharmaceutical companies, patient-partners and trialists worldwide. Her work has helped ensure that patient quality of life and symptom data is captured and reported in a rigorous way that can meaningfully inform patient care, regulatory decision-making, clinical guidelines and health policy.

Richard Riley, who has been newly awarded the accolade, is Professor of Biostatistics at the Institute of Applied Health Research and a researcher within the NIHR Birmingham BRC’s Data, Diagnostics and Decision tools research theme. He leads a team of statisticians undertaking applied and methodology research for healthcare, especially in regard to prognosis, prediction models, and evidence synthesis. He is Deputy Chief Statistics Editor for The BMJ and was named as a ‘Highly Cited Researcher’ in 2023. He works passionately to improve medical research by developing, promoting and educating about the importance of high methodology standards in study design, analysis and reporting.

He commented: “I am delighted to receive this award from the NIHR. Statisticians and methodologists play a critical role in undertaking and improving medical research, and having my contributions recognised by the NIHR is truly humbling. I would like to thank the many research collaborators and mentors who have supported my career, and I look forward to further championing methodology and guiding the NIHR community in the coming years.”

NIHR Senior Investigators are among the most prominent researchers funded by the NIHR. This award is presented to outstanding researchers developing health and care research capability to improve the future health of the nation, with reach into both academia and the health and care system.

Senior Investigators play an important role in guiding research capacity development and strengthening the career paths of NIHR researchers, which includes participating as mentors in the NIHR mentoring programme.

In addition to the title, Senior Investigators also receive an award of £20,000 per year of appointment to fund activities that support their research. They are usually appointed for 4 years, for a maximum of two terms to ensure turnover.

Major contract awarded for a concussion research programme from the US Department of Defense

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Early diagnosis and detection.

Birmingham experts in neurology have been awarded a seven-year contract by the U.S. Department of Defense – which could be worth up to $15.5m – to undertake a major research programme aiming to transform the way concussion is identified and managed.

Some 890 people across the UK, aged 18 to 60, will take part in the study which will measure the ability of a range of biomarkers – such as blood and saliva, mental health, vision, balance and sleep – to predict long-term complications from mild Traumatic Brain Injury (mTBI), also known as concussion. The  mTBI-Predict study will see researchers measure effectiveness of various methods to predict outcomes of mTBI after six, 12 and 24 months.

mTBI can be caused by physical impact to the head through accident, injury, sport, or even from shockwaves following explosions. Led by the Royal Centre for Defence Medicine (RCDM) and the University of Birmingham, researchers will use the UK TBI Research Network to recruit both civilian and military participants to the programme.

mTBI Predict will be supported by Birmingham Health Partners and University Hospital Birmingham, as well as a range of research institutions across the UK.

Professor Alex Sinclair, from the University of Birmingham, who will lead the study said: “Concern around the long-term effects of concussion is mounting. Even a minor injury to the head can cause concussion, which leads to brain injury with potentially serious effects on both immediate and long-term health.

“We have no precise way to tell who will have a serious consequence after a concussion. This means we can’t tell which patients will need more intensive treatment and which will recover spontaneously. The mTBI Predict research program will identify new ways to accurately predict whether concussion patients will develop long-term complications.”

Concussion has been declared a major global public health problem, with 1.4 million hospital visits due to head injury annually in England and Wales. Some 85% of these are classified as concussion and it is also estimated that up to 9.5% of UK military personnel in a combat role are diagnosed with concussion every year.

Major General Timothy Hodgetts CB CBE KHS, Surgeon General of the UK Armed Forces, commented:

“UK Defence has funded the initiation of this research, but it would not be possible to complete without the support from US DoD. This is a prime example of our longstanding bilateral research collaboration where we have a common purpose to address a significant and shared clinical problem. This study will be definitive in helping us identify those who need the most help and resources following a very common injury.”

The research programme brings together a team of experts including neuroscientists, psychologists, sport and exercise scientists, software developers and statisticians – coordinated by Birmingham Clinical Trials Unit.

The study will recruit patients with concussion related to sports injuries, road accidents, cycling accidents, falls and accidents at work, and military personnel experiencing concussion during training or active duty. It will involve military patients and expertise from the Defence Medical Rehabilitation Centre Stanford Hall and Royal Centre for Defence Medicine.

Dr. David J. Smith, from the US Department of Defense, commented: “The US Department of Defense is excited to support this study and continue to identify threats to the brain, such as blast overpressure, head impact, directed energy, and environmental hazards.

“These threats may have a direct impact on brain health. Our aim is to reduce risks to the brain, monitor exposures, and document them for long-term review. The goal is to look for multiple protection strategies to decrease exposures and protect brains better. This research will play a pivotal role in continuing our research investments partnering with the UK to better understand mTBI and concussion to prevent and reduce their effects.”

Although classed as mild brain injury, concussion leads to a disproportionate impact on future health, with three in 10 patients unable to work 12 months after their injury. The consequences of mTBI are profound, with many patients suffering long-term disability due to persistent headaches, imbalance, memory disturbance and poor mental health.

mTBI-Predict will look at biomarkers to enable faster diagnosis and assessment of a concussion, leading to improvements in treatment and long-term management, enabling a quicker return to play, work or duty.

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New research will target earliest stages of bone marrow cancer

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

A new programme, funded by Cancer Research UK and led by BHP founder-member the University of Birmingham, has set out to attempt to eradicate a major and incurable bone marrow cancer.

An interdisciplinary team of researchers will investigate the underpinning biology of the very early stages myeloma, a cancer that develops from plasma cells – a type of white blood cell – made in the bone marrow. This is game changing research because the early stage, called MGUS, is common and only an unpredictable minority of cases go on to develop the killer disease of myeloma.

MGUS patients have non-cancerous expansion of immune cells in their bone marrow. In most patients this will be stable for many years and will never cause significant harm. The problem is that, in some patients, the cells will become more aggressive and cause full-blown cancer.

For decades it has not been possible to sufficiently tell these two types of patients apart. Until now this challenge has been considered insurmountable resulting in all cases of myeloma being diagnosed very late. However, thanks to the funding by Cancer Research UK it is time to make a change. Using biological and bioinformatic research the team aim to devise ways of accurately predicting which patients with MGUS are truly at risk of developing life threatening myeloma and those that will not.

With the help of experts in the economic challenges faced by health providers such as the NHS the team will then will design the best possible screening strategies to detect the disease and the quickest possible route to clinical trials of ways to prevent myeloma occurring.

Lead researcher Chris Bunce is Professor of Translational Cancer Biology, in the School of Biosciences at the University of Birmingham. He said: “Despite decades of academic and pharmaceutical company research, costing eye watering amounts of money and human endeavour, a cure for myeloma remains elusive.

“All myeloma cases, however, arise from an easily diagnosed pre-condition that remains virtually ignored by researchers. This funding from Cancer Research UK reverses that stance and turns the focus onto the very early stages of myeloma with a view to stopping the disease in its tracks.”

The research aims to provide a deeper understanding of how specific chemicals in the blood change as patients transition from MGUS towards developing myeloma. These changes – first identified by researchers at the University of Birmingham – could help distinguish ‘high risk’ MGUS from ‘low risk’ MGUS, as well as helping to identify potential drug targets for treatment.

Mark Drayson, Professor of Clinical Immunodiagnostics in the University’s Institute of Immunology and Immunotherapy, and co-lead research for the project, said: “By bringing together different approaches and expertise we aim to overcome the existing barriers to developing an effective test for stratifying risk of progression from MGUS to myeloma that is recognised as both affordable and effective.”

Dr Marianne Baker, Science Engagement Manager at Cancer Research UK, said: “To beat cancers that are often diagnosed late, like myeloma, we need to understand the earliest stages of its development – the underlying biology of the disease. This is a historically underfunded area, so we’re excited to see what the project brings; the more our researchers discover, the less room cancer has to manoeuvre. It’s vital we translate results into innovations, like tests that can predict risk, and give treatment the best chance of success.”

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Improving screening in underrepresented groups for genetic condition with heart complications

Written by Louise Stanley on . Posted in Early diagnosis and detection, Health inequalities.

Researchers from across BHP are collaborating with community groups and Amicus Therapeutics to improve screening and diagnosis of Fabry disease, a rare and inherited condition where complications affect the heart muscle, and can lead to premature death.

Through the project, the team – from University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham – has begun to build advisory groups in collaboration with community leaders, healthcare professionals and patients from black, South Asian and other minority ethnic groups. These advisory groups will support researchers to understand patient perspectives on possible barriers to diagnosis, as well as possible approaches to breaking down these barriers. Once further funding is secured, these approaches will be trialled locally in Birmingham, a super-diverse city.

The incidence rate of Fabry disease in the general population is reportedly around 1 in 100,000, although this is likely an underestimate of its true prevalence. Although Fabry disease is very rare, as a genetic condition, patient’s family members have a higher likelihood of the disease that the wider population. Therefore, family screening and mapping is an important tool to identify more cases.

Identifying Fabry disease is important, since the earlier that a patient is diagnosed the better the prognosis for treatment. There are several therapies available, including enzyme replacement and methods to make the faulty enzyme that causes Fabry disease work better, all of which are more effective if started earlier. Without treatment, patients may develop significant cardiac, renal and cerebrovascular complications.

Project lead Richard Steeds, Honorary Professor of Cardiovascular Medicine and Deputy Director of Clinical Research within the Institute of Cardiovascular Sciences at the University of Birmingham and Consultant in Cardiovascular Imaging at University Hospitals Birmingham, explained: “Previous work has shown that Black, South Asian, and other minority ethnic groups, as well as patients from lower socioeconomic groups, are underrepresented in our clinic in Birmingham, despite it being a very diverse city. This knowledge helped us to identify a need for further research to understand and overcome specific barriers to family screening that are more prevalent within minority ethnic groups. If we can address these barriers, then we can support more people to benefit from beginning treatment for this rare condition sooner. Working with members of different community groups is essential to making this work.”

It is well established that minority ethnic groups face health inequalities from language barriers, lower health literacy and cultural difference that contribute to stigma and fear of discrimination that can impact on help seeking behaviours. These inequalities can lead to poorer health outcomes, so addressing them is vital.

Fabry disease can often take many years and several doctors’ appointments to diagnose because many of the symptoms are also attributed to more common causes. Family screening has the potential to help identify more cases sooner.

Some of this work has been funded through a collaboration project with Amicus Therapeutics.

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University of Birmingham awarded £7m NIHR funding to provide strategic leadership for its Research Support Service

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

The NIHR has selected BHP founder-member the University of Birmingham to run the National Collaborative for its Research Support Service (RSS) from 1 February 2024. 

The RSS was launched on 1 October 2023. The service provides expert research design, methodological support, advice, and collaboration to all researchers in England throughout the pre- and post-application/research process, regardless of geographic location and research interest. 

Since launch, the service has received more than 840 requests for support from researchers through its 8 hubs. The specialist centres in social care and public health have received a combined total of 171 requests for support.   

The new function

The new RSS National Collaborative will be run by the University of Birmingham. The university has demonstrated a clear commitment to work with all NIHR RSS hubs through collaboration. 

Among other responsibilities, the new function will:

  • provide strategic and operational leadership across the 8 individual NIHR RSS hubs
  • develop collaborative working with other components of the NIHR’s infrastructure. This includes the NIHR Clinical Research Network and incoming Research Delivery Network, in particular around the deliverability of studies within the chosen setting
  • identify, develop and share standards of good practice. The function will support their implementation, and provide the highest quality resources to support the development and delivery of health and care research
  • support Research Inclusion, and Patient and Public Involvement, Engagement and Participation in the hubs, to encourage a coordinated national approach

The aim of the new function is to enable the 8 hubs to provide consistency of service across the RSS. It will supply a core team, with dedicated senior academic, clinical and operational leadership. 

Professor Marian Knight, NIHR Scientific Director for Research Infrastructure, said: “The National Collaborative is critical to the successful delivery of the new Research Support Service, which since October has been providing expert advice and support to researchers across England. By leading the Collaborative, the University of Birmingham will work with the other RSS Hubs to ensure all researchers across England are provided with the tailored support they need and to develop an environment of continuous improvement across the service.”

Neil Thomas, Professor of Epidemiology and Research Methods, Operations Director of the RSS National Collaborative, said: “I am looking forward to leading this exciting collaboration alongside Professor Katie Morris, Director of the Birmingham Clinical Trials Unit, who is our Academic and Clinical Lead. We look forward to working with all 8 RSS Hubs and Specialist Centres, the NIHR and the wider research community in developing and delivering health and care research. Our vision of collaboration is wide ranging and we have ambitious plans to build capacity in our workforce and public contributors, contribute to the development of inclusive and innovative research methodologies, as well as harmonise systems across our service.”

Find out more about the Research Support Service.

LIBERATE heart attack trial treats first patient

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

The first patient has been treated in the LIBERATE clinical study to evaluate glenzocimab efficacy in myocardial infarction, which involves BHP members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust (UHB).

In 2022, the University  signed a partnership agreement with Acticor Biotech to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE.

Having obtained full regulatory approval in August 2023, two clinical research sites, the Queen Elizabeth Hospital in Birmingham – part of UHB – and the Northern General Hospital in Sheffield, are involved in the study. The Queen Elizabeth Hospital opened to recruitment on 24th January 2024. It is expected that the Northern General Hospital in Sheffield will also open to recruitment by the end of February 2024.

The LIBERATE study, a randomiSed, double-blind Phase 2b trial, will enrol over 200 patients diagnosed with ST-elevation myocardial infarction (STEMI) and scheduled for percutaneous coronary intervention. The primary objective of the study is to evaluate both the safety and efficacy of glenzocimab at a dosage of 1000 mg compared to a placebo, specifically focusing on the reduction of myocardial infarct size at Day 90 post-treatment.

Professor Jon Townend, Chief Investigator of the trial who works across BHP members the University of Birmingham and UHB as Consultant Cardiologist and Honorary Professor of Cardiology, said: “We have entered the operational phase of the trial, and I extend my gratitude to the entire team in Birmingham and Sheffield for their outstanding efforts in managing patient recruitment in these critical emergency care settings, as well as for gathering qualitative data for subsequent analysis.”

Dr Mark Thomas, Associate Professor of Cardiology at the University of Birmingham and Honorary Consultant Cardiologist, who designed the trial and led its development, said: “This is the first time worldwide that this class of medication has been investigated in patients with heart attacks, after showing great promise in patients with stroke. We are grateful to our patients for helping us in our mission to find new treatments that may help to reduce the damage done by heart attacks.”

Professor Robert Storey, Professor of Cardiology at the University of Sheffield and Honorary Consultant Cardiologist and Director of the Cardiovascular Research Unit at Northern General Hospital, said: “This study is exploring the potential of glenzocimab in reducing the type of blood clotting responsible for heart damage during heart attacks. This exciting collaboration with University of Birmingham and Acticor Biotech holds the potential to bring significant benefit to people suffering from a heart attack.”

Adeline Meilhoc, Head of Global Clinical Development of Acticor Biotech said: “We are delighted to witness the operational start of the study, and we reiterate our complete confidence in our partners as crucial contributors of its success. Acticor Biotech is dedicated to advancing treatments for the acute phase of thrombotic diseases. Glenzocimab application in ST-segment elevation myocardial infarction (STEMI) represents a significant focal point for Acticor Biotech’s commitment to medical advancement.”