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Month: January 2025

New national Centre of Excellence in AI and digital health awarded to Birmingham

BHP founding member the University of Birmingham has been awarded £1M to help the UK unlock the opportunity of AI and digital healthcare while ensuring technologies are safe and effective.

Birmingham will host the ‘Centre of Excellence for Regulatory Science and Innovation in AI & Digital Health Technologies’ known as ‘CERSI-AI’, alongside six key founding partners who bring together knowledge and skills from academia, the NHS, the regulators and industry, and will also work with a wider international network.

The founding partners represent an established UK network with exceptional strength in the innovation and regulation of AI, including universities (University of Birmingham, University of York), industry (Hardian Health, Newton’s Tree, Romilly Life Sciences, and the Association of British HealthTech Industries) and the NHS (University Hospitals Birmingham NHSFT and NHS Greater Glasgow and Clyde).

Working across the health and technology ecosystem, the Centre will identify and address current and future needs and opportunities in the regulation of AI and digital healthcare products and services on behalf of the government. Key to the Centre’s role will be balancing the needs of innovators, such as speed and market certainty, with those of the end-users, such as cost-effectiveness, safety, equity and sustainability, to ensure resulting technologies are able to truly improve people’s lives.

Professor Alastair Denniston, Executive Director of CERSI-AI, said: “We have a national mandate to work with the regulators. We identify problems, use scientific methodology to create solutions and then close relations with government, strengthened through the establishment of this Centre, mean that we can implement these solutions quickly. Our vision is to enable the UK to become the best place for innovators to develop, evaluate and market new products and services, ensuring benefit for both patients and healthcare providers.”

Professor Neil Hanley, Pro-Vice-Chancellor and Head of the College of Medicine and Health at the University of Birmingham and Executive Director of Birmingham Health Partners, said: “I’m really excited by this award. We have a tremendously strong reputation for working in regulatory and implementation science. Nowhere is this more relevant than in the Government priority of AI, so it is wonderful we have been chosen to take this forward as the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust under the umbrella of Birmingham Health Partners. Alongside our Birmingham Health Innovation Campus, this is yet more evidence underlining the national significance of our Health & Life Sciences District.”

Innovate UK – the UK’s innovation agency, in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences, and the Medical Research Council have announced a total of seven Centres of Excellence for Regulatory Science and Innovation (CERSIs), including the Centre hosted by University of Birmingham. The projects, led by academic institutions, independent innovators, or regulatory leaders forming collaborative partnerships, will receive funding up to £1 million each, to lead the way in safer, faster pathways for innovative medicines and devices.

The new network of Centres aims to improve healthcare by simplifying how treatments move from lab bench to patient bedside. By helping researchers and businesses address regulatory challenges and opportunities, the Centres will help accelerate the delivery of pioneering treatments, ensuring patients benefit from cutting-edge innovations.

These seven CERSIs will tackle key challenges in regulatory science, in areas such as Advanced Therapies, Precision Medicines, Digital Healthcare, Drug Discovery and Diagnostics. Over the coming year, the CERSIs will develop tools, frameworks, and guidance to help shape the development and approval of medical innovations in the UK.

Science Minister, Lord Vallance, said: “New technologies are transforming our economy at rapid pace. Our system of regulation must keep up with that, so that we can quickly and safely seize the economic and social benefits that new innovations could unlock. This is particularly true for life sciences, where innovative medical technologies, treatments, diagnoses and therapies are just around the corner.

“That is why we are launching CERSIs. They will make a valuable contribution to regulatory innovation – and will complement wider efforts to make the UK’s regulation fit for the future, such as that of our Regulatory Innovation Office.”

Ailsa Kennedy-Ballard, Deputy Director Innovation Programmes & Partnerships at Innovate UK, said: “Innovate UK is pleased to announce these seven new CERSIs, which represent a landmark in healthcare innovation regulation.

“Backed by up to £1 million each, they will drive safer pathways for groundbreaking medicines and devices, ensuring the UK remains at the forefront of global medical advancements.

“By fostering collaboration between academia, business and regulators, these Centres will pave the way for life-changing innovations to reach patients more swiftly and safely.”

Dr June Raine, MHRA Chief Executive, said: “The establishment of CERSIs cements the UK’s role at the forefront of regulatory science, driving forward the innovations of tomorrow while upholding our unwavering commitment to public health. This first-of-its-kind programme embeds innovation at the very heart of our regulatory processes. 

“By empowering UK academic institutions to shape the future of regulatory science, it ensures medical advancements reach patients more quickly and safely. Through close collaboration with academic and industry leaders, we are building a regulatory system that doesn’t just keep pace with innovation but actively propels it forward.” 

Dr Glenn Wells, Deputy Executive Chair at Medical Research Council said: “We are delighted to partner with Innovate UK and the MHRA to establish new CERSIs.

“Regulation plays an essential role in improving the nation’s health, by supporting the MHRA to engage with our community we will help shape the regulatory landscape and leverage the MHRA’s world leading research to advance innovations in healthcare and regulatory science.”

More information on CERSI-AI can be found at: www.cersi-ai.org.

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New AI tools set to advance early cancer detection and prevention

Birmingham researchers are to play a role in Cancer Research UK’s recently announced £10 million AI detection programme, jointly supported by the National Institute for Health and Care Research (NIHR) and the Engineering and Physical Sciences Research Council (EPSRC) and involving 18 institutions including BHP founder-member the University of Birmingham.

Over the next five years, the Cancer Data-Driven Detection programme will harness vast quantities of data, link datasets and develop new tools to predict cancer risk – ultimately increasing the number of people diagnosed with cancer at its earliest stages.

The programme aims to access and link data from different sources – including health records, genomics, family history, demographics, and behavioural data – to develop advanced statistical models that help scientists accurately predict who is most likely to get cancer. Alongside this, the programme will develop powerful new tools which use AI to analyse the data and calculate an individual’s risk of cancer throughout their lifetime.

Researchers from University of Birmingham will take on specific roles in the programme, alongside approximately 40 others working together collaboratively. Professor Sudha Sundar, gynaecological cancer surgeon and a clinical academic in the University’s Department of Cancer and Genomic Sciences, is advising as a clinical practitioner in the multi-cancer risk prediction area of the work. Dr Ameeta Retzer from the Centre for Evidence and Implementation Science will lead on the cross-cutting Equity, Diversity and Inclusion theme, drawing on her expertise in health inequalities and research equity.

Dr Ameeta Retzer said: “Across the whole programme we will work to embed equality, diversity and inclusion since we know that cancer doesn’t affect everyone equally. It is vital that we ensure our research will benefit everyone, across all communities, equitably and that’s why I look forward to ensuring this strand of work has prominence in all areas of the programme.”

Over the next five years, the funding will build the infrastructure required to access and link these datasets, train new data scientists, create the algorithms behind the risk models and evaluate the algorithms and AI tools to ensure that they are giving accurate and clinically useful information about cancer risk.

The models generated from this research could be used to help people at higher risk of cancer in different ways. For example, the NHS could offer more frequent cancer screening sessions or screening at a younger age to those at higher risk, whilst those at lower risk could be spared unnecessary tests. People identified as higher risk could also be sent for cancer testing faster when they go to their GP with possible cancer signs or symptoms. Individuals at higher risk could also access different ways to prevent cancer.

Professor Sudha Sundar, whose clinical practice is based at BHP member Sandwell and West Birmingham NHS Trust, commented: “With cancer cases on the rise, it is essential that we work to identify and diagnose cancers earlier so that patients can begin treatments soon, which in most cancers vastly improves their quality of life and chances of survival. Screening is one way of identifying cancer sooners. Multi-cancer earlier detection tests represent an exciting progression in the scope of cancer screening programmes and this is part of the Cancer Data-Driven Detection programme that is exciting to explore further.”

The scientific programme will be guided by partnerships with cancer patients, the public, clinical experts and industry, while addressing ethical and legal considerations to ensure that the models and tools work well in practice.

Professor Antonis Antoniou, Director of the Cancer Data Driven Detection programme and Professor of Cancer Risk Prediction at the University of Cambridge, said: “Finding people at the highest risk of developing cancer, including those with vague symptoms, is a major challenge. The UK’s strengths in population-scale data resources, combined with advanced analytical tools like AI, offer tremendous opportunities to link disparate datasets and uncover clues that could lead to earlier detection, diagnosis, and prevention of more cancers.

“The Cancer Data Driven Detection programme will build the partnerships and infrastructure needed to make data-driven cancer early detection, diagnosis and prevention a routine part of frontline healthcare. Ultimately, it could inform public health policy and empower individuals and their healthcare providers to make shared decisions. By understanding individual cancer risks, people can take proactive steps to stop cancer before it gets worse or even begins in the first place.”

Earlier diagnosis of cancer saves lives. Yet according to analysis of NHS figures by Cancer Research UK, only 54.4% of cancers in England are diagnosed at stages one and two, where treatment is more likely to be successful. NHS England has set a target to diagnose 75% of cancers at stages one and two by 2028, and this will only be achieved with research and embracing new technologies to catch cancer earlier.

Professor Lucy Chappell, Chief Scientific Adviser at the Department of Health and Social Care (DHSC) and Chief Executive Officer of the NIHR, commented: “Detecting and diagnosing cancer earlier is key to improved survival and quality of life for patients. By leveraging AI to enable healthcare professionals to identify people at a greater risk of cancer, this initiative could improve the way patients are screened and diagnosed. This programme’s AI-driven insights could lead to more effective treatment and improved survival, helping patients to live longer, healthier lives.”

The Cancer Data Driven Detection programme is jointly supported by Cancer Research UK, the National Institute for Health & Care Research, the Engineering & Physical Sciences Research Council, Health Data Research UK, and Administrative Data Research UK.

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Researchers at the Royal Orthopaedic Hospital secure funding to develop cancer-killing injectable paste for bone tumours

The Dubrowsky Lab at BHP member the Royal Orthopaedic Hospital (ROH) has secured a £110k grant from Orthopaedic Research UK to develop an injectable paste with anticancer and bone regenerative properties.

The project will see researchers at ROH work with BHP members Aston University to produce an injectable paste comprised of gallium-doped bioglass that, if proved effective, could be used to treat patients with primary and metastatic bone cancer.

Dr Lucas Souza, Research Lab Manager at the Dubrowsky Lab and Lead Researcher for this new project, comments: “Advances in treatment of bone cancer have reached a plateau over the past 40 years, in part due to a lack of research studies into treatments and the complexity and challenges that come with treating bone tumours. Innovative and effective therapeutic approaches are needed and this grant from Orthopaedic Research UK provides vital funds for us to continue our research into the use of gallium-doped bioglass in the treatment of bone cancer.”

Gallium is a metallic element that has cancer-killing properties. When combined with bioactive glass the material can kill cancer cells that remain when a tumour is removed and accelerate the regeneration of the bone defect. In addition, the material also prevents bacterial contamination in the surgical site. A recent study led by Aston University in collaboration with the ROH found that bioactive glasses doped with the metal have a 99 percent success rate of eliminating cancerous cells.

The injectable paste is to function as a drug delivery system for localised delivery of anticancer gallium ions (GaBG) and bisphosphonates whilst regenerating bone. The team hypothesise that the GaBG and bisphosphonates will promote rapid bone formation and will prevent cancer re-occurrence by killing residual cancer cells and regulating local osteoclastic activity.

The new therapeutic approach will be particularly useful in reducing cancer re-occurrence, implant site infections and implant failure rates in cases of bone tumours where large resections for complete tumour removal is either not possible, e.g. when tumours are located too close to vital organs, or not recommended, e.g. in the treatment of bone metastases and aggressive benign bone tumours (such as Giant-cell tumour of bone) when the harm inflicted by a large surgical procedure may be greater than its benefits. It could also be used in combination with minimally invasive intralesional therapies such as cryoablation or radiofrequency ablation for optimal management of metastatic bone lesions.

Dr Lucas Souza adds: “The proposed biomaterial has the potential to drastically improve treatment outcomes of bone tumour patients by reducing cancer re-occurrence, implant-site infection rates, and implant failure rates leading to reduced time in hospital beds, less use of antibiotics, and fewer revision surgeries. Taken together, these benefits could improve survival rates, functionality and quality of life of bone cancer patients.”

Dr Lucas Souza will be supported by Professor Adrian Gardner, Director of Research and Development at the Royal Orthopaedic Hospital and Professor of Clinical Orthopaedics at Aston University, as well as Mr Jonathan Stevenson, Orthopaedic Oncology and Arthroplasty Consultant. The project is also supported by collaborators Professor Richard Martin and Dr Eirini Theodosiou from Aston University and Professor Joao Lopes from the Brazilian Aeronautics Institute of Technology.

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Aston University and Birmingham Children’s Hospital study shows diagnosis and treatment of preschool wheeze needs improvement

A study led by Aston University’s Dr Gemma Heath and  Dr Prasad Nagakumar from Birmingham Children’s Hospital – both BHP member organisations – has shown that treatment and diagnosis for preschool wheeze needs more effective evidence-based guidelines.

Preschool wheeze affects approximately 30–40% of children under six. The condition is characterised by episodes of wheezing or breathlessness, with younger children being particularly susceptible due to their narrower airways. Although it can resemble asthma, preschool wheeze is often triggered by viral infections or allergies and does not always mean a child will develop asthma.

The UK has Europe’s second highest prevalence of preschool wheeze in two-year-olds and is a leading cause of emergency hospital visits and hospitalisations in the country. Repeated preschool wheeze attacks are frightening for parents, and result in significant morbidity, healthcare costs and impaired quality of life for both the child and parent.

There is currently no diagnostic pathway or definitive management guidelines for preschool wheeze. The research team interviewed affected parents and carers about their experiences, and found problems with diagnosis and treatment at multiple levels.

The first major issue identified by parents was inconsistent terminologies used by doctors, and confusing and conflicting diagnoses such as asthma, suspected asthma, viral wheeze and allergy. Some reported frustration at the lack of definitive diagnosis, an apparent lack of GP knowledge, sometimes false reassurance that the wheeze was viral rather than asthma, or that the cause was a “mystery”.

A common problem was that investigative tests did not occur until after multiple hospitalisations. Blood tests for particular markers have potential to identify whether asthma or an allergy is likely to have caused the wheeze, and therefore guide treatment. The parents in the study welcomed the idea of timely tests, but stressed that children should not be subjected to repeated testing.

Preschool wheeze is generally managed with steroid and salbutamol inhalers, as for asthma. While parents had concerns about the side-effects and long-term impacts of using the treatments, they deemed the medication “an acceptable cost”.

Parents reported being “terrified” while watching attacks of preschool wheeze, and significant psychological impacts when their child was admitted to hospital. Some had missed work or even given up work to care for their child, with high levels of anxiety, while others said they felt unable to go on holiday overseas due to concerns about healthcare access in the case of a wheeze attack.

Most parents preferred to access care at hospital rather that at doctors’ surgeries due to the perception of a lack of training for GPs and a lack of confidence. However, accessing necessary care can be difficult, including due to childcare difficulties, the cost of hospital parking and a lack of available ambulances.

The research team said that parents’ views highlight the problems and called for clinical trials to determine the efficacy of treatment decisions made according to the results of investigations.

Dr Heath said: “This research demonstrates an urgent need for preschool wheeze management policies and treatment pathways that are evidence-based and co-developed with parents. We have shown that use of investigations such as blood or allergy tests would be acceptable to parents, if they were shown to be helpful in guiding more effective and timely treatments.”

Dr Nagakumar said: “Preschool wheeze has significant impact on young children’s and their parents’ lives. Our research, involving parents with lived experience, will inform future studies to improve the care and reduce the impact of preschool wheeze on the already-stretched emergency health services in the UK.”

Archives of Disease in Childhood doi: 10.1136/archdischild-2024-327781

Increasing transparency and tackle potential bias in medical AI technologies: BHP researchers publish new recommendations

Patients will be better able to benefit from innovations in medical artificial intelligence (AI) if a new set of internationally agreed recommendations – published in The Lancet Digital Health and NEJM AI – are followed.

Led by the University of Birmingham and University Hospitals Birmingham NH Foundation Trust, ‘STANDING Together (STANdards for data Diversity, INclusivity and Generalisability)’ is an international initiative and its recommendations are based on a research study involving more than 350 experts from 58 countries, aiming to help improve the way datasets are used to build Artificial intelligence (AI) health technologies and reduce the risk of potential AI bias. 

Innovative medical AI technologies may improve diagnosis and treatment for patients, however some studies have shown that medical AI can be biased, meaning that it works well for some people and not for others. This means some individuals and communities may be ‘left behind’ or may even be harmed when these technologies are used.

The STANDING Together recommendations aim to ensure that medical AI can be safe and effective for everyone. They cover many factors which can contribute to AI bias, including:

  • Encouraging medical AI to be developed using appropriate healthcare datasets that properly represent everyone in society, including minoritised and underserved groups;
  • Helping anyone who publishes healthcare datasets to identify any biases or limitations in the data;
  • Enabling those developing medical AI technologies to assess whether a dataset is suitable for their purposes;
  • Defining how AI technologies should be tested to identify if they are biased, and so work less well in certain people. 

Dr Xiao Liu, Associate Professor of AI and Digital Health Technologies at the University of Birmingham and Chief Investigator of the study said: “Data is like a mirror, providing a reflection of reality. And when distorted, data can magnify societal biases. But trying to fix the data to fix the problem is like wiping the mirror to remove a stain on your shirt. To create lasting change in health equity, we must focus on fixing the source, not just the reflection.”

The STANDING Together recommendations aim to ensure that the datasets used to train and test medical AI systems represent the full diversity of the people that the technology will be used for. This is because AI systems often work less well for people who aren’t properly represented in datasets.

People who are in minority groups are particularly likely to be under-represented in datasets, so may be disproportionately affected by AI bias. Guidance is also given on how to identify those who may be harmed when medical AI systems are used, allowing this risk to be reduced.

Professor Kiran Patel, Chief Medical Officer at University Hospitals Birmingham NHS Foundation Trust (UHB), said: “In the UK, and especially in cities like Birmingham, where communities from diverse backgrounds form a significant part of the population, ensuring diversity in datasets is essential for improving health outcomes for all patients.”

“As technology advances, these recommendations are crucial in preventing the health inequalities we know exist in our communities from persisting or worsening, ensuring vulnerable populations have access to the treatments they need.”

The research has been conducted with collaborators from over 30 institutions worldwide, including universities, regulators (UK, US, Canada and Australia), patient groups and charities, and small and large health technology companies.

The work has been funded by The Health Foundation and the NHS AI Lab and supported by the National Institute for Health and Care Research (NIHR), the research partner of the NHS, public health and social care.

In addition to the recommendations themselves, a commentary published in Nature Medicine written by the STANDING Together patient representatives highlights the importance of public participation in shaping medical AI research.    

Sir Jeremy Farrar, Chief Scientist of the World Health Organisation, said:  “Ensuring we have diverse, accessible and representative datasets to support the responsible development and testing of AI is a global priority. The STANDING Together recommendations are a major step forward in ensuring equity for AI in health”

Dominic Cushnan, Deputy Director for AI at NHS England, said: “It is crucial that we have transparent and representative datasets to support the responsible and fair development and use of AI. The STANDING Together recommendations are highly timely as we leverage the exciting potential of AI tools and NHS AI Lab fully supports the adoption of their practice to mitigate AI bias’’

The recommendations were published on Wednesday 18 December 2024, and are available open access via The Lancet Digital Health.

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