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Behind the scenes – meet the ROH research team

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

Written for BHP by Ellie Keeling, Lead Research Nurse at the Royal Orthopaedic Hospital

Birmingham is a major research hub with a thriving collaborative ecosystem convened by Birmingham Health Partners. Within this alliance, the Royal Orthopaedic Hospital (ROH) is leading the way in orthopaedic research, conducting clinical trials, observational studies, and laboratory research. Our work focuses on enhancing physiotherapy rehabilitation, developing therapies for bone tissue regeneration, and creating pharmaceutical treatments to reduce invasive surgeries and speed up recovery. ROH’s research aims to improve patient care, facilitate early diagnosis, support new drug development, and offer alternative treatments, consistently contributing new findings to the field.

The majority of this work happens behind the scenes. And the roles that make up this team are varied. They include our lab manager who oversees the management of the Dubrowsky Lab; research nurses; a research tissue bank co-ordinator; study co-ordinators; assistant clinical research practitioners; data managers; and a healthcare technician.

Research nurses play a vital role in delivering clinical research, guiding the patient as they go through the clinical research process and ultimately improving patient care and treatment pathways. It’s an incredibly diverse role, from recruiting patients for studies to collecting and tracking samples, and developing pathways to improve the delivery of trials. Because many clinical trials run over the course of several years, research nurses get to work with the same patients regularly and are able to build up a rapport with them.

Our research tissue bank co-ordinator manages our research tissue bank, which was established over thirty years ago and contains the world’s largest archive of frozen bone tumour samples – currently numbering 32,000 – including all orthopaedic malignancies as well as other benign and non-tumour tissue types. The research tissue bank is used by researchers across the globe who need access to bone and tissue samples that they can’t get elsewhere, with the samples supporting clinical projects to better understand cancers like chondrosarcomas (cancer of the cartilage cells) or develop new treatments for primary bone cancer.

The team is involved in a number of clinical trials, including the BASIS study and the RACER Hip and Knee studies. We are one of the main recruiting centres for the BASIS study, which is trying to find out which type of back brace is best for treating children and young people with scoliosis. The RACER Hip and Knee studies are exploring clinical effectiveness of robotic assisted hip and knee replacement. Pivotal to the success of these studies is patient recruitment – working closely with patients and recruiting them onto these clinical trials with empathy. Our assistant clinical research practitioners (ACRPs) are critical here, as this research couldn’t happen without the generosity of patient donations and their time. In this role, ACRPs work closely with patients to explain what research we are doing, explore how the patient could potentially participate in this research and support them through the process.

It’s essential that patient donations are viable and there are several steps required to ensure this. The role of the healthcare technician is a rare role, but a key one at ROH as it enables a clear and consistent pathway for the effective collection and packaging of patient bone and tissue samples.

Finally, our data managers keep all this work running smoothly by supporting the team with the collection and storing of patient data. This support helps our researchers identify what patient data could support new and existing clinical research as well as retrospective data-led research, all the while ensuring compliance and confidentiality.

While many research roles, especially in hospitals, are perceived as being behind the scenes, they are incredibly important bringing unique skills and knowledge and their contribution is crucial in making breakthroughs that can improve lives.

For more information on The Royal Orthopaedic Hospital’s research activities, visit Royal Orthopaedic Hospital – Research (roh.nhs.uk).

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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.