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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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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.”

New treatment combination may improve outcomes for children with rare cancers

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

Children who develop neuroblastomas, a rare form of cancer which develops in nerve cells, may benefit from receiving certain anti-tumour drugs as well as chemotherapy, a new trial has found.

The results of the BEACON trial conducted by the Cancer Research UK Clinical Trials Unit (CRCTU) at BHP founder-member the University of Birmingham found that combining anti-angiogenic drugs, which block tumours from forming blood vessels, alongside various chemotherapy drugs led to more young people seeing their tumours shrinking, from 18% in the control group to 26% among those on Bevacizumab.

The findings have been published in the Journal of Clinical Oncology. The trial saw 160 young people aged 1-21, from 43 hospitals in 11 European countries, randomised with half receiving the anti-angiogenic drug called Bevacizumab on top of conventional therapy. The group who received Bevacizumab had an increase in the likelihood of responding to treatment, from 18% among those who only had the established therapy to 26% for those with the additional drug. Patients who received Bevacizumab additionally had better one year progression-free survival rates.

The trial constituted one of many collaborations between the University of Birmingham and European expert groups SIOPEN (International Society of Paediatric Oncology European Neuroblastoma) and ITCC (Innovative therapies for children with cancer).

Simon Gates, Professor of Biostatistics and Clinical Trials at the University of Birmingham and senior lead author of the paper said: “These are very exciting results that hopefully get us closer to finding treatments for children who develop neuroblastomas. Currently, the outcomes are really poor for children who get this horrible cancer and so even seemingly small increases in the chance that a patient is going to be able to shrink their tumours is significant.

“We are delighted that the BEACON trial has helped to shape treatment for children with relapsed and refractory neuroblastoma going forward.”

Dr Lucas Moreno, Head of Paediatric Haematology and Oncology at Vall d’Hebron University Hospital, Barcelona, Spain and Chief Investigator for the study said: “BEACON was a hypothesis-generating trial that has served to identify active regimens that are now being further investigated. We are delighted that the data generated has been incorporated into the current UK Clinical Practice Guidelines and Bevacizumab is incorporated into standard treatment for relapsed neuroblastoma.”

Professor Amos Burke appointed Director of Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU)

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

Professor Amos Burke has been appointed as the new Director of the Cancer Research UK Clinical Trials Unit, based at BHP founder-member the University of Birmingham.

Professor Burke – a paediatric oncologist and has held a consultant position in the NHS since 2004 – joins the Unit from Cambridge University Hospitals NHS Foundation Trust.  With a particular interest in childhood lymphomas, Professor Burke chaired the UK paediatric Non-Hodgkin Lymphoma subgroup of the National Cancer Research Institute (NCRI) Lymphoma Clinical Studies Group (2010-2018), remaining an active member (2019-2023). Since 2023 he has been the Deputy Chair of the UK Children’s Research Group (currently supported by the Children’s Cancer and Leukaemia Group).

Commenting on his appointment, Amos said: “I am delighted to be joining CRCTU as it approaches its 40th year of CRUK funding as a result of its work under the leadership of the former Directors, most recently Professor Pam Kearns who brought children’s cancer trials into the unit during her tenure. CRCTU is nationally and internationally known for its trials in childhood and adult cancer, addressing unmet clinical needs and leading the use of innovative trial design. I look forward to leading CRCTU going forward as new approaches to increasingly complex trials involving more global collaboration are required.”

As the new Director of the CRCTU, he is responsible for the delivery of clinical cancer trials for children and young people in England. The CRCTU collaborates with clinician investigators driving cutting-edge research, with a focus on treatments that will change outcomes for people with cancer.

Professor Burke is currently the Chief Investigator for the innovative platform trial Glo-BNHL for children with relapsed and refractory mature B-cell Non-Hodgkin Lymphoma.

Rare disease trials to develop playbook for testing new treatments

Written by Louise Stanley on . Posted in Clinical trials.

Patients with rare diseases could benefit from a ‘revolution’ in clinical trials that could see one-stop studies designed to provide robust results even with small numbers of participants.

The CAPTIVATE node is part of the recently introduced UK Rare Disease Research Platform established as part of a £14 million investment over five years by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR).

Led by BHP founder-member the University of Birmingham along with collaborators at the Universities of Sheffield and Liverpool, the CAPTIVATE node will be developing a methodology to run a ‘one-stop-study’, which would encompass all phases of clinical trials to enable the efficient evaluation of treatments for rare diseases.

The CAPTIVATE node will bring together the UK’s leading trial experts with hospital researchers experienced in rare diseases, industry partners, policy makers and patient partners, and the resulting designs could speed up the approval of medicines for use in rare diseases.

Professor Lucinda Billingham at the University of Birmingham is the lead academic for the CAPTIVATE node of the MRC-NIHR UK Rare Disease Research Platform. She explained: “One of the biggest challenges with developing new treatments or improving existing ways of treating rare diseases is that the model of clinical trial that is used as standard is incredibly difficult to run where there may be only hundreds of people around the world at any one time with that disease.

“Added to this fact, in the UK three quarters of rare diseases affect children and more than 30% of children with a rare disease die before their fifth birthday.

“The CAPTIVATE node is looking to scale a revolutionary model of clinical trial that runs all the phases together and can get clinically significant results even with very small numbers of patients. We want to find ways that need as few people to take part as possible, that are quicker and that provide all the information needed for the authorities to approve a new medicine to be prescribed to people with rare diseases from one single trial.”

Bringing together strengths in rare diseases

The MRC-NIHR UK Rare Disease Research Platform is now getting up and running and will bring together UK strengths in rare diseases research to improve diagnosis and treatment through better understanding of the disease.

It is made up of a central coordination and administrative hub and 11 specialist nodes based at universities across the UK, including the CAPTIVATE node at the University of Birmingham.

The aim of the platform is to bring together expertise from across the UK rare disease research system to foster new and innovative treatments for those directly and indirectly impacted by rare conditions.

Professor Lucy Chappell, Chief Executive of the NIHR, commented: “The UK Rare Disease Platform marks a significant advance in accelerating rare disease research, supported through NIHR funding and our partners the Medical Research Council. The platform will enable greater collaboration between patients and those working across academic, clinical and industry research. By bringing the right people and expertise together, we will be able to provide better care more quickly to those living with rare diseases.

“The NIHR continues to lead essential ongoing research into rare diseases, including through our Biomedical Research Centres, and we are making it easier for people with rare diseases to take part in research opportunities via our Be Part of Research Service, which can now be accessed through the NHS app in England. We look forward to working with our partners further to accelerate our understanding and treatment of rare diseases affecting millions of people across the UK.”