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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.

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.”

Center of Excellence Award Renewal for Allergy, Asthma and Immunology Center

Written by Louise Stanley on . Posted in Birmingham Health Partners, Inflammation and chronic disease.

The Allergy, Asthma, and Clinical Immunology Center in Birmingham has been successful in renewing its Center of Excellence status for another four-year term – re-affirming the Center’s international recognition for multidisciplinary scientific and clinical innovation – following a successful bid led by Professor Mamidipudi Thirumala Krishna, representing Birmingham Health Partners.

Renowned for its innovative services to accelerate education and research, the Institute of Immunology and Immunotherapy, and the School of Pharmacy at the University of Birmingham in collaboration with the West Midlands Allergy and Immunology service at University Hospitals Birmingham (UHB) NHS Foundation Trust has once again been designated as a World Allergy Organisation (WAO) Center of Excellence.

There are currently 82 Centers worldwide, and only three other similar Centers of Excellence in the UK.

According to the World Allergy Organisation (WAO), their Centers of Excellence accelerate multidisciplinary science and clinical innovation, training, and advocacy worldwide to deliver world-class education, research, and training to stakeholders in asthma, allergy, and clinical immunology.

Professor Mamidipudi Thirumala Krishna said: “This continued recognition of our Center of Excellence signifies our commitment to delivering world-class clinical services, fostering excellence in education and research, and nurturing collaborative relationships both nationally and internationally and contributing to global health.”

Professor Ben Willcox, Director of the Institute of Immunology and Immunotherapy at the University of Birmingham, commented: “We are proud to see our Center of Excellence renewed, guided by the visionary leadership of Professor Krishna. We have over 50 years of experience in world-leading immunology research, and this Center’s status renewal is testament to that.”

Professor Anthony Cox, Head of the School of Pharmacy and Professor in Clinical Pharmacy and Drug Safety, said: “Great news that the World Allergy Organisation Center of Excellence has been extended. The School of Pharmacy is proud to be working with the center on issues related to allergy and medicines – including inappropriately identified drug allergies which have a considerable impact on patient safety and the rational use of medicines.”

Dr Richard Baretto, Clinical Service Lead for the Department of Allergy and Immunology at UHB, added: “This prestigious award from the World Allergy Organisation is testament to the efforts of all the members of the clinical teams, providing excellent care for our patients with allergic disease. It emboldens us all to strive for continued improvement in our service through regular review, research and innovation.”

Professor Adel Mansur, Lead for Birmingham Regional Severe Asthma Service, commented: “On behalf of the Birmingham Regional Severe Asthma Service I am delighted of the news of extending our status as World Allergy Organisation Center of Excellence, recognising the excellent work done in Birmingham. Over the last three years tremendous work and development have been achieved to further strengthen our Center in areas of research, education and training and to lead on clinical excellence in allergy, asthma and clinical immunology.”

“We have adopted various initiatives to improve our patients outcomes, access and equity of service delivery and provide conducive environment for our trainees to learn and develop skills and further their career.  Our national and international contribution to research and education in these fields are also important developments and targets to progress further over the next 4 years which I look forward to with excitement.”

Dr Gareth Walters, NHS consultant in occupational respiratory medicine and interstitial lung diseases in Birmingham, also added: “On behalf of the Birmingham Regional NHS Occupational Lung Disease Service , we are very pleased that our status as a World Allergy Organization Center of Excellence has been renewed for a further 4 years. This is testament to the hard work and dedication of our multi-disciplinary team, who go above and beyond to diagnose and manage a range of occupational lung diseases.”

The Allergy, Asthma and Immunology Center will continue to lead global healthcare innovation and pursue its commitment to excellence in research and education for another term commencing in 2024 to 2028. 

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Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions

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

During pregnancy, women and pregnant individuals who do not identify as women* can develop a range of pregnancy-specific conditions, such as preeclampsia and gestational diabetes, that can adversely affect both their own health and that of the developing foetus during the pregnancy. These conditions can affect the lifelong health of both mother and child. Despite the danger that these conditions present to mother and baby, there are few approved, safe and effective medicines to treat them, and limited investment in novel therapy development.

To map out key barriers and potential enablers of preclinical research and experimental medicine to support the development of new medicines for pregnancy-specific conditions, the Academy of Medical Sciences, Birmingham Health Partners, and Concept Foundation organised a multi-sectoral FORUM workshop in September 2023. People with lived experience joined representatives from academia, the commercial sector, clinical practice (including doctors and midwives), regulatory authorities, funding bodies, charities, and patient advocacy groups at the meeting.

The result of this workshop is a new report – Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions – which highlights the need to raise awareness of the importance of research in pregnancy, and give women opportunities to participate.

> Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions – view and download the report here

This work builds upon the BHP-led Pregnancy Policy Commission which in 2022 published its Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe, Effective and Accessible Medicines for Use in Pregnancy report, proposing a clear roadmap to improve the lives of millions of people, not just for women while they are pregnant, but for future generations.

Professor Peter Brocklehurst, Emeritus Professor at BHP founder member the University of Birmingham, commented: “We need to better understand the biological mechanisms of pregnancy-specific conditions so that we can develop therapies that target these processes. To do this, we need more health data and biological samples from women with those conditions.”

Forum participants identified the following six priority areas for next steps:

    1. A cross-sectoral and cross-speciality network or coalition, including women with lived experience, to provide a platform for collaboration and to coordinate efforts to promote the development of new medicines for pregnancy-specific conditions.
    2. Additional interdisciplinary research and cross-sector collaboration to address key knowledge gaps (including the biology of the placenta, of the early stages of pregnancy, and of pregnancy-specific conditions), to enable appropriate use of animal models and physiologically based pharmacokinetic (PBPK) modelling, and to leverage routinely collected health data and patient samples.
    3. The establishment of a more enabling environment for research in pregnancy, for example through development of a stronger research base and a more supportive regulatory environment.
    4. Greater engagement with women to raise awareness of the importance of research into pregnancy and of opportunities to participate in this research, including when women contact the healthcare system.
    5. Education and training of healthcare professionals, including midwives, to promote research in pregnancy.
    6. Advocacy to secure greater prioritisation of research in pregnancy (and women’s health more generally) by policymakers, funders, and higher education institutions.

The workshop was chaired by Professor Peter Brocklehurst FMedSci, Emeritus Professor of Women’s Health at the University of Birmingham, and Dr Pauline Williams CBE FMedSci, an independent pharmaceutical medicine consultant and former Senior Vice-President and Head of Global Health R&D at GlaxoSmithKline.

* The Academy acknowledges that not all pregnant people identify as women. While the terms ‘woman’ and ‘mother’ are used here, many of the learnings from the workshop about obstetric/pregnancy-specific conditions are expected to be widely applicable. It is recognised that there will be specific experiences and challenges associated with obstetric conditions among pregnant individuals who do not identify as women that were not explored at the workshop given the lack of specific research in this area. 

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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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