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.
Pregnant women with epilepsy could see a major improvement in the care they receive through a new cross-BHP project led by the University of Birmingham with Birmingham Women’s and Children’s Hospitals NHS Foundation Trust (BWC), which also aims to reduce maternal mortality risk.
The EpiSafe project, funded by the National Institute for Health and Care Research over five years, will create and trial an evidence-based, personalised care bundle specifically designed for pregnant women with epilepsy.
The team of researchers, led by Professor Shakila Thangaratinam from the University of Birmingham and BWC, will provide healthcare professionals with the tools and guidance they need to streamline the care they provide and allow for shared decision-making with women regarding their epilepsy and pregnancy.
The EpiSafe project will also study the long-term effects of newer anti-epileptic drugs (AEDs) on children’s development. Many mothers are prescribed these newer AEDs due to concerns with older medications, yet they often discontinue them out of fear of potential harm to their baby.
As part of this study, the researchers across BHP will bridge the knowledge gap by assessing the long-term neurodevelopmental outcomes of children exposed to newer AEDs during pregnancy. This research will empower pregnant women with epilepsy, enabling them to make informed decisions about the safe use of AEDs.
“Epilepsy continues to be one of the main causes of mothers dying in pregnancy and postpartum period. Sadly, we are not observing a fall in maternal deaths. On the contrary, there has been a doubling of the rates of Sudden Unexpected Death in Epilepsy (SUDEP) in mothers between 2013-15 and 2019-21 in UK and Ireland.
“We know that the primary factors contributing to these poor maternal outcomes are the lack of specialist antenatal care and reduced compliance with anti-seizure medication. The EpiSafe programme of work has the potential to improve the care these women receive and save lives within this high-risk group.”
At the core of the EpiSafe programme are mothers with lived experiences of epilepsy from diverse backgrounds. They will play a pivotal role throughout the lifetime of the programme in shaping the development and roll-out of the EpiSafe bundle. Charity partners on the programme include Epilepsy Research Institute and Epilepsy Action, who will provide invaluable insight and guidance.
Dr John Allotey, Associate Professor in Epidemiology and Women’s Health at the University of Birmingham and project leader said: “By working with diverse groups of women with epilepsy and their families, professional bodies, organisations providing care for pregnant women with epilepsy, as well as dedicated epilepsy charities, we will develop an acceptable, relevant and accessible tool which identifies pregnant women with epilepsy who are at high risk and promotes safe use of AED.”
The project consists of six work packages to create the EpiSafe risk assessment and treatment pathway, that will facilitate early specialist epilepsy care for high-risk women. The team will also evaluate whether EpiSafe will help more women at high-risk access specialist epilepsy care early in pregnancy.
The Epilepsy Research Institute’s Director of Research Partnerships, Dr Caoimhe Twohig-Bennett, said: “The Institute launched last month with Reproduction & Hormones as one of our overarching strategic research theme. We are delighted to be collaborating on the EpiSafe project, to ensure safer care and reduced risks for pregnant women with epilepsy.“Central to the work of the Epilepsy Research Institute is a culture of advocating and actioning the research priorities of people affected by epilepsy through our Shape Network PPIE group. Members of the network have been pivotal in the development of this programme of research, and we look forward to their continued involvement as this important project progresses.”
Rajinder Flora, Assistant Director of NIHR’s Programme Grants for Applied Research (PGfAR), which funds the research, said: “Epilepsy causes 1 in 10 of all deaths during pregnancy in the UK, this new project aims to identify women with epilepsy who are at highest risk of seizures and create a treatment pathway for them.
“Funding research like this is vital to provide evidence-based personalised care for pregnant women with epilepsy”
The EpiSafe team also includes co-applicants from University of Liverpool, University of Manchester, Birmingham City University, University of Aberdeen and Belfast Health and Social Care trust, as well as partnerships with Kings Health Partnership and Murdoch Children’s Research initiative.
The EpiSafe work streams consist of:
Gathering all evidence needed to design the EpiSafe bundle,
Co-designing and testing the EpiSafe bundle by working with women and healthcare professionals,
A randomised controlled trial to see if using the EpiSafe bundle improves care, reduces seizures and complications in mother and baby,
Studying the longer-term development of children aged 7-11 exposed to AEDs before birth,
Studying the cost of using EpiSafe and its long-term impact, and
Planning appropriate involvement and engagement with women with epilepsy and their support networks.
Parliamentary event
At a parliamentary event to launch the project hosted by former Health Minister Baroness Cumberlege – who chaired key report on harmful side effects of some medicine – patients and researchers explained about how important this project is for ensuring that women across the UK get a say in managing epilepsy during pregnancy.
Addressing the event, Baroness Cumberlege said: “Being pregnant is a very important stage for every woman, conscious that if all goes well she is bringing new life into the world. The EpiSafe programme is crucial in creating evidenced based pathways which must ensure the voices and experience of women directly shape solutions. The success of this programme will only be realised if there is meaningful collaboration between researchers, clinicians, and women with epilepsy and their families. Cooperation is vital to spur change.
“All those involved in the care of pregnant women have a duty to safeguard the wellbeing of all mothers with chronic health needs. I will follow the progress of innovations borne from initiatives such as this closely, and with the help of others advocate tirelessly for their swift translation into enhanced standards of care.”
Researchers from BHP founder-member the University of Birmingham have designed and developed a novel diagnostic device designed for the early detection of traumatic brain injury (TBI), which works by shining a safe laser into the eye.
Described in Science Advances, the technique is dramatically different from other diagnostic methods and is now expected to be developed into a hand-held device for use in the crucial ‘golden hour’ after TBI, when life-critical decisions on treatment must be made.
The device incorporates a class 1, CE-marked, eye-safe laser and a unique Raman spectroscopy system, which uses light to reveal the biochemical and structural properties of molecules by detecting how they scatter light, to detect the presence and levels of known biomarkers for brain injury.
There is an urgent need for new technologies to improve the timeliness of TBI diagnosis, which is a leading cause of death worldwide. TBI is caused by sudden shock or impact to the head, which can cause mild to severe injury to the brain, and although it needs diagnosis and treatment as soon as possible to prevent further irreversible damage, it is hard to diagnose at the point of injury. Additionally, radiological investigations such as X-ray or MRI are very expensive and slow to show results.
Birmingham researchers, led by Professor Pola Goldberg Oppenheimer from the School of Chemical Engineering, designed and developed the novel diagnostic hand-held device to assess patients as soon as injury occurs. It is fast, precise and non-invasive for the patient, causing no additional discomfort, can provide information on the severity of the trauma, and will be suitable to be used on-site – at the roadside, on the battlefield or on the sports pitch – to assess TBI.
The device works by scanning the back of the eye where the optic nerve sits. Because this nerve is so closely linked to the brain, it carries the same biological information in the form of protein and lipid biomarkers. These biomarkers exist in a very tightly regulated balance, meaning even the slightest change may have serious effects on brain health. TBI causes these biomarkers to change, indicating that something is wrong.
Previous research has demonstrated the technology can accurately detect the changes in animal brain and eye tissues with different levels of brain injuries – picking up the slightest changes.
The device detailed in the current paper detects and analyses the composition and balance of these biomarkers to create ‘molecular fingerprints’. The study details the development, manufacture, and optimisation of a proof-of-concept prototype, and its use in reading biochemical fingerprints of brain injury on the optic nerve, to see whether it is a viable and effective approach for initial ‘on-scene’ diagnosis of TBI.
The researchers constructed a phantom eye to test its alignment and ability to focus on the back of the eye, used animal tissue to test whether it could discern between TBI and non-TBI states, and also developed decision support tools for the device, using AI, to rapidly classify TBIs.
The device is now ready for further evaluation including clinical feasibility and efficacy studies, and patient acceptability.
The researchers expect the diagnostic device to be developed into a portable technology which is suitable for use in point-of-care conditions capable to rapidly determine whether TBI occurs as well as classify whether it is mild, moderate or severe, and therefore, direct triage appropriately and in timely manner.
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.”
Prescribing vaginal progesterone treatment early in pregnancy appears to reduce risk of developing preeclampsia – a potentially fatal condition – by approximately 39%, a recent research review suggests.
Collaborating through the Tommy’s National Centre for Miscarriage Research, Dr Pedro Melo from the University of Oxford, and Dr Adam Devall and Professor Arri Coomarasamy from BHP member the University of Birmingham have analysed the findings of 11 recent studies involving 11,640 women.
These studies were originally designed to explore the impact of progesterone on reducing miscarriage or preterm birth rates. In every study, data were also collected on whether the same treatment affected rates of preeclampsia or other high blood pressure (hypertensive) disorders in women during pregnancy.
The review, published in the British Journal of Obstetrics and Gynaecology, concludes that vaginal progesterone appears to reduce risk of hypertensive disorders in pregnancy, but only when treatment is started in the first trimester.
The review showed that, compared to a placebo, 400 mg of vaginal progesterone used twice a day was associated with a 39% reduction in preeclampsia and a 29% reduction in the rate of other hypertensive disorders such as gestational hypertension.
Starting progesterone early in pregnancy appears to be critical: no clear evidence was found through this review to suggest that starting progesterone in the second or third trimesters had an effect.
Frequency, quantity, and method of use are also important: 400 mg used twice daily as a vaginal capsule showed a benefit in reducing risk of preeclampsia and other hypertensive disorders but using 400 mg once a day did not.
“The recent PROMISE and larger PRISM trials led to an exciting breakthrough in finding evidence that progesterone can reduce miscarriage risk in some women when used in the first trimester. This evidence led to updated NICE guidelines in 2021 recommending its use. But the signal we found in the data for progesterone’s effectiveness in reducing hypertensive disorders had not previously been demonstrated.
“These are exciting preliminary findings, but it must be stressed that they were secondary results of trials focusing on the use of progesterone for the prevention of miscarriage and preterm birth, not preeclampsia. We need a large randomised controlled trial focusing specifically on women and birthing people at risk of preeclampsia to confirm our hypothesis that progesterone supplementation may tackle abnormal implantation in this subgroup of people” said Dr Pedro Melo, lead author of the study at the Tommy’s National Centre for Miscarriage Research at the University of Birmingham and the Nuffield Department of Women’s and Reproductive Health at the University of Oxford.
Dr Adam Devall, Institute of Metabolism and Systems Research, University of Birmingham, added: “The preliminary finding from this study suggests vaginal micronised progesterone might reduce the risk of preeclampsia. The researchers are calling for a large multi-centre clinical trial to explore the effects of progesterone in women at risk of preeclampsia.”
The 11 studies analysed focused on groups of pregnant women who either had a history of recurrent pregnancy loss or had a threatened miscarriage (i.e., they were experiencing early pregnancy bleeding). The review recommends that future studies are needed to explore the link further, to find out whether the reductions of 29-39% are relevant to all women and birthing people and whether the effect could be larger for those who have risk factors for preeclampsia.
Preeclampsia is a condition that affects some pregnant women, usually during the second half of pregnancy or soon after their baby is delivered. Preeclampsia can lead to fetal growth restriction which can cause premature birth. If severe, it can be dangerous, sometimes even fatal, for mothers.
Progesterone plays an important role in implantation of the embryo as it helps make the tissue lining the uterus receptive to implantation. By giving vaginal progesterone, researchers believe it is possible to combat problems with the lining of the womb and partly correct abnormal implantation, helping support successful development of the blood vessels in the placenta. This would reduce the chance of developing conditions such as preeclampsia.
“This research further supports Tommy’s calls for women with a history of miscarriage and pregnancy bleeding to be given progesterone in the early stages of pregnancy. We must continue to keep exploring progesterone’s potential and improve understanding of what it can be used for, who it works best for, when, and how” explained Kate Davies, Research Director at Tommy’s.
The second city’s strategic University-NHS alliance, Birmingham Health Partners (BHP) has announced the appointment of experienced business leader Jonathan Pearson as its new Chair, tasked with implementing an ambitious new strategy.
Bringing extensive experience as a management consultant and a profound understanding of the health and life sciences sector, Jonathan has established and guided numerous healthcare enterprises, spearheaded significant growth, and led large-scale transformation and technology programmes. He has also served within the NHS as Independent Chair of the Sandwell and West Birmingham Health System, bringing together a unique blend of high-level industry and health service expertise.
Jonathan’s contributions to the sector have earned him several prestigious accolades throughout his career. Notably, he was honoured with the Healthcare Deal of the Year award in 2014 by Acquisition International, recognised by the Management Consultancy Association in 2015 for thought leadership, and received the HSJ award for Analytic Provider of the Year in 2019. His exceptional leadership in the Sandwell ICP’s Covid vaccination program was further acknowledged with the Local Government Association award in 2021.
BHP is a strategic alliance uniting two renowned Universities, five NHS Trusts and Health Innovation West Midlands, with the shared aim of transforming healthcare across our region by leveraging collective strengths in clinical and technological innovation, research, and education.
Commenting on his appointment, Jonathan said: “Birmingham Health Partners is a powerhouse of research at the heart of an ambitious city and region, with a strong track record of scaling innovation from the bench to the bedside at pace. Together with its wider regional partners, BHP is already working to address pressing health challenges and deliver economic growth and this work will only be enhanced by the imminent launch of our new strategy which will benefit our communities, region and workforce. It is an incredibly exciting time to join the partnership.”
