Author: Louise Stanley

Birmingham academic appointed Clinical Lead of new NIHR network

Written by Louise Stanley on 01/09/2025. Posted in Birmingham Health Partners, Clinical trials.

The National Institute for Health and Care Research (NIHR) has awarded £6.5 million, funded jointly through a public-private partnership with the pharmaceutical industry, to establish a UK-wide Commercial Research Delivery Centre (CRDC) Network. The Network is hosted by University Hospitals of Leicester NHS Trust (UHL), with Birmingham Health Partners’ Managing Director Professor Lorraine Harper as its Clinical Lead, and will commence formally on 1 September 2025.

The new Network will provide strategic coordination of all 21 CRDCs across the the UK. It will play a key role in building research capacity, streamlining the interface between industry and the UK clinical trials delivery infrastructure, and enhancing efficiency to deliver commercial clinical research through harmonised processes, in line with the Government’s call to turbocharge medical research earlier this year.

The Network will:

Provide strategic leadership and national coordination across the 21 CRDCs across the UK
Offer a central point of contact for industry sponsors
Facilitate study feasibility, placement and setup across the UK
Foster collaboration with regulators, wider NIHR and UK-wide delivery infrastructure, and other key stakeholders to advance UK Clinical Research Delivery
Support workforce development, inclusion, and public involvement
Facilitate the integration of the Primary Care CRDCs (PC-CRDCs) in England in autumn 2025, adopting them into the Network

By aligning CRDC efforts and offering a cohesive offer to industry, the Network will ensure that the CRDCs deliver against industry expectations for faster, more efficient set up and delivery of commercial research in the UK.

Lorraine Harper, Professor of Nephrology at the University of Birmingham and Managing Director of Birmingham Health Partners, is the Director of the Central and North West Midlands CRDC and has been appointed Clinical Lead of the new Network. She said: “The vision of the Network is to ensure equitable access, diverse recruitment and a much more efficient model of trial delivery, improving NHS and patient access to trials. With Birmingham Health Partners already leading a regional programme to reduce bureaucracy in clinical trials, and BHP member Birmingham Women’s and Children’s Hospitals hosting the Central and North West Midlands CRDC, this is an exciting opportunity to align all our work and deliver a ‘gold standard’ for commercial clinical trials.”

BHP founding member Birmingham Women’s and Children’s Hospitals NHS Foundation Trust hosts the £7m Central and West North Midlands (C&NWM) CRDC, working closely with regional partners Midlands Partnership University NHS Foundation Trust – host of Staffordshire and Shropshire, Telford and Wrekin Health Research Partnership (SSHERPA) – and the Black Country Provider Collaborative.

The C&NWM region, home to 4.2 million people, includes many of the UK’s most economically deprived communities who face significant health inequalities and higher rates of serious illness. The CRDC will focus on addressing these inequities by increasing access to clinical trials for patients who have the greatest need – dovetailing with BHP’s strategic focus on addressing health inequalities and giving greater opportunities for residents to participate in research.

Professor Melanie Davies, Professor of Diabetes Medicine at the University of Leicester and Honorary Consultant Diabetologist for University Hospitals of Leicester NHS Trust, and Director of the CRDC Network, said: “We are really proud that University Hospitals of Leicester NHS Trust has been awarded this funding to host this federated CRDC Network across the four nations of the UK. We are fully committed to working with our partners across the UK to deliver faster, more efficient set up and delivery of commercial research. We want to drive increased investment from industry and enable even more people to take part in studies that can lead to the future approval of new medicines and devices for the benefit of patients in the UK.”

Dr Maria Koufali, NIHR Life Sciences Industry Director, said: “The UK CRDC Network is a critical part of our national effort to transform UK clinical research delivery. By streamlining trial set-up and expanding access into community and underserved settings, it will help make the UK one of the most attractive destinations globally for commercial research. This means faster access to innovative treatments for patients, greater investment in the NHS and a stronger life sciences sector that boosts the health and wealth of the nation.”

Adding dendritic cell vaccine to liver cancer therapy slows disease progression

Written by Louise Stanley on 29/08/2025. Posted in Clinical trials, Experimental medicine.

Patients with intermediate-stage primary liver cancer who received a vaccine of dendritic cells (DC) alongside their cancer therapy saw a longer time without tumour progression in response to standard treatment – found a study by BHP founding-member the University of Birmingham, funded by the National Institute for Health and Care Research (NIHR).

The results of the ImmunoTACE trial, the first clinical trial of its kind, published in Clinical Cancer Research, found improved progression-free survival (PFS) for patients with hepatocellular carcinoma (HCC) who received the cell-based vaccine expanded from their own white blood cells. The vaccine was administered alongside usual treatment with tumour chemoembolisation, a treatment for blood vessels that feed the tumour, plus chemotherapy.

The collaborative trial between the University of Birmingham, fellow BHP members University Hospitals Birmingham, Nottingham University Hospitals NHS Trust and Aintree University Hospital and Clatterbridge saw 48 patients recruited to receive either standard treatment alone or standard treatment plus a cellular vaccine using dendritic cells loaded with cancer antigens to stimulate immune responses against the cancer.

In the experimental arm of the trial the average time to progression of the tumour was 18 months compared with only 10 months in the group who only received standard treatment.

Professor David Adams, Chief Investigator of the study, Emeritus Professor of Hepatology at the University of Birmingham and past Director of BHP, said: “The results from this phase 2 trial are very promising and offer a potential new treatment option for patients with primary liver cancer, one of the highest causes of cancer-related death worldwide.

“As far as we know, ImmunoTACE is the first controlled clinical trial to show that a cell-based vaccine using lab-grown dendritic cells can improve patient outcomes with liver cancer. The results warrant further investigation and could in future offer much needed hope and a better treatment option for patients.”

The vaccine is made with dendritic cells (DC) which help orchestrate the immune system’s response to diseases including cancer by activating immune killer cells to recognise and destroy cancer cells.

The dendritic cells used in the study were expanded from the patients’ own white blood cells by growing them in a purpose-built laboratory for eight days with proteins taken from cancer cells. The cells allow the immune system to see these proteins and then to mount an immune attack on the cancer cells that bear them.

Patients received the DC vaccine at the same time as standard treatment with chemo-embolisation and then monthly for a further three months.

While dendritic cells are produced naturally in the body, studies have shown that in patients with cancer they can become “exhausted” and get stuck within the tumour rather than carrying cellular information back to the lymph nodes where they can activate immune killer cells. The idea of DC vaccine is to restore and uncover immune responses to the cancer. The current trial design reports that this therapy can be both affordable and effective.

Dr Yuk Ting Ma, lead author of the study and Associate Clinical Professor at the University of Birmingham, and an Honorary Consultant in Hepatobiliary Oncology at the University Hospitals Birmingham NHS Foundation Trust said: “These are very promising findings that demonstrate the potential use of dendritic cell vaccines in a widely prevalent and hard to treat cancer. With our approach to developing the vaccine, focusing on stimulation with multiple tumour antigens, we have shown a strong signal that we believe warrants testing in larger trials in patients with liver cancer.

“Dendritic cell vaccines also represent a potential additional immune therapy to add to current checkpoint inhibitors. Future studies will look at whether adding DC vaccination to standard immunotherapy can derive better outcomes for patient with HCC who show only modest responses to current checkpoint inhibitor drugs.”

New trial to test novel diagnostic for bladder cancer recurrence

Written by Louise Stanley on 28/08/2025. Posted in Clinical trials, Early diagnosis and detection.

Nonacus, an early cancer testing company, has announced two West Midlands-based trials to assess a new way of monitoring for recurrence of bladder cancer, using a novel test developed in collaboration with researchers from BHP founding-member the University of Birmingham.

The at-home urine test uses Nonacus’ highly-sensitive liquid biopsy technology, which was developed in conjunction with a panel of biomarkers developed by researchers from the University’s Bladder Cancer Research Centre.

Called Galeas Bladder, the test was developed while the company based itself at the University’s bio-incubator, the BioHub Birmingham, and a previous Cancer Research UK-funded study has already shown that it can accurately and consistently detect the presence of bladder cancer from a urine sample.

Professor Rik Bryan, Director of the Bladder Cancer Research Centre, said: “These trials are the culmination of eight years of collaborative research and development between the University of Birmingham and Nonacus, which has the potential to help the millions of patients at higher risk of bladder cancer across our country and worldwide.”

Tony Hickson, Chief Business Officer at Cancer Research UK said: “As funders of much of the world-class, cutting-edge cancer research happening in the UK, we offer unique opportunities to commercial partners looking for early involvement in new discoveries. Having Nonacus on board to help transform promising findings in the lab into a new non-invasive test to diagnosis bladder cancer is a testament to how commercial collaborations have the potential to transform the lives of patients. We are looking forward to seeing the next steps as the test is developed and rolled out to the UK and beyond.”

Jeannie Rigby, CEO of Action Bladder Cancer, said ” Bladder cancer can often be diagnosed late and has a high level of recurrence – which can lead to poor outcomes for patients – and bladder cancer has been neglected in terms of new research in the past. Action Bladder Cancer UK, bladder cancer patients and their families, welcome this exciting development in improving testing for bladder cancer.”

Richard Parker, Mayor of the West Midlands, commented: “Health-tech is about better care for patients, shorter waiting times and more good jobs here in the West Midlands. Through my Growth Plan we are making this one of the best places in the country to develop and roll out new treatments – from expanding our innovation clusters to supporting local medtech businesses to grow and export. The technology I’ve seen today is proof that when we back science, patients and the economy both win.”

Peter Kyle, Secretary of State for Science, Innovation and Technology, added: “In a region renowned for engineering, with Richard Parker as Mayor, the West Midlands is setting the pace for medical technology. Nonacus’ innovative approach to testing for bladder cancer will help save patients time and the NHS money. Life sciences is a growth sector for the West Midlands and the UK as a whole combining the power of our universities, the creativity of our businesses and the strength of our NHS.”

Strict regulations needed to address commercial health self-test concerns

Written by Louise Stanley on 28/07/2025. Posted in Early diagnosis and detection.

Far greater regulation is needed for off-the-shelf health tests, due to considerable concerns over both suitability of the tests for the public, and accuracy of claims made on-package.

In a series of papers published by The BMJ, researchers from BHP founder-member the University of Birmingham funded by the NIHR Birmingham Biomedical Research Centre reviewed a range of commercially-available health tests bought in shops. The work was carried out due to concerns that directions for use, usability of equipment, and incorrect interpretation of results could cause harm.

Thirty self-test kits were purchased from major supermarkets, pharmacies and health and wellbeing shops, including tests for vitamin deficiency, blood cholesterol, menopause and bowel cancer. Accuracy claims were made for 24 of the tests, and most (14/24; 58%) claimed a performance of at least 98% accuracy, sensitivity or specificity. However, evidence supporting these accuracy claims was largely unavailable or didn’t provide sufficient information for the likely end users of such tests.

Where information about the methods used to estimate test accuracy was available in instruction leaflets (17/30 tests), the accuracy of five tests (5/17; 29%) was evaluated against a similar test rather than a more reliable and accurate test. In addition, the descriptions of participants involved in these studies was mostly lacking, preventing an assessment of the relevance of accuracy estimates to the general public.

The study also highlights issues with the usability and safety of tests, with 18 self-tests being identified as having potential to give an erroneous result or action. The team also identified:

11 tests with problems in the equipment
10 with problems in the sampling process
15 with problems in the instructions or the interpretation of the results

Researchers involved in the study are now calling for better regulation and guidance for manufacturers, retailers and healthcare professionals to protect consumers of off-the-shelf health self-tests.

Professor Jon Deeks at the University of Birmingham and corresponding author of the study said: “A plethora of new health self-tests have emerged in recent years and are available to buy from many high street supermarkets and pharmacies in the UK. While these kits have been approved for sale, they are not subject to the same stringent regulations as pharmaceutical products.

“Our recent research raises concerns about the suitability, accuracy and usability of many of the self-testing products available that require users to sample, test and interpret results themselves. In some cases, it is unclear how accuracy claims are supported, and there is no requirement of manufacturers to share the evidence behind these claims.

“Our findings highlight concerns about the value of these self-tests because the instructions for use for many of them recommended seeing a doctor regardless of the test result (positive or negative).”

Dr Clare Davenport, Clinical Associate Professor at the University of Birmingham and co-author of the study said: “The wide range of off-the-shelf tests now available to the public are not endorsed by the NHS and evidence for their benefit is lacking. This is in contrast to well-established self-tests, such as pregnancy tests.

“We are worried that consumers concerned about their health and tempted by the convenience of buying a test over the counter may be harmed if they use these tests in the wrong way.”

New medicines or interventions must undergo a stringent regulatory process, including clinical trials and registration with the MHRA. In contrast, medical self-test devices are subject to less stringent checks by Notified Bodies, and this has allowed certain self-tests to be sold in the UK, despite them raising concerns.

New regulatory standards should ensure better reporting of studies of self-tests to support transparency of test claims, according to the research team. The researchers also assert that more emphasis should be placed on ensuring the clinical studies of self-tests are conducted appropriately. In particular, self-tests should not only be tested in laboratories, but they should also be evaluated by the people and for the purposes for which they are intended to be used.

Dr Clare Davenport said: “The same consideration given to pharmaceuticals should be given to self-testing where some, such as pregnancy tests, could be sold over the counter and others that carry greater risk of misuse are sold only with the support of a pharmacist. These latest studies have also shown that information and data that support claims of accuracy, specificity or sensitivity needs to be available to the public.”

Professor Jon Deeks said: “Current regulations for the use of self-testing kits in a commercial setting are not adequately protecting consumers. Several of the self-test manufacturers refused to provide us with reports of their studies, which support their claims, stating that they were “commercially confidential”. Legally, they do not need to share this information. However, for all matters of our health, it really is important that the evidence upon which health decisions are made is available and can be scrutinised.”

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Pardeep Janjua and Carlos Chan take home summer BHP People awards

Written by Louise Stanley on 24/07/2025. Posted in BHP People, Birmingham Health Partners.

July’s BHP People awards have been awarded to Pardeep Janjua, Research Data and Systems Officer at Sandwell and West Birmingham Hospitals (SWB) and Carlos Chan, Research Development Coordinator at the Royal Orthopaedic Hospital (ROH).

Our reward and recognition scheme is designed to spotlight our colleagues who play a vital role in the success of research studies and clinical trials, and whose work is integral to groundbreaking scientific endeavours.

Pardeep was nominated by SWB’s Head of Research & Development Kelly Hard, who said: “Over the last two years Pardeep has worked tirelessly to provide robust quality datasets across the organisation that can be utilised for all areas of research. He has co-designed these reports with the needs of clinicians, researchers and leaders in mind, which has enabled better oversight of all elements resulting in increased awareness, understanding and ultimately, better outcomes.

“Pardeep has presented this work at two international conferences and it has also earnt him an internal Trust award. He has been upscaling this work across the Black Country and is now in discussions to extend beyond.

“These data sets and report not only aid in decision making for individual projects and researchers but have enabled us to baseline and benchmark departments to enable new initiatives.”

We met with Pardeep to find out a little more about his journey from pharmacy to data management, and the challenges and opportunities of scaling his work from SWB across the region more widely. Read his story here: “BHP People – the ultimate goal is to make research more accessible”.

Nominating Carlos, the ROH’s Head of Research, Audit and Development Gareth Stephens, said: “Carlos came to R&D at ROH after relocating his family from Hong Kong to the UK. He started with us in a Band 2 administrative role; however, his project management and IT skills were very quickly apparent. These skills have seen him successfully climb the ladder within R&D, initially as a Data Manager and now as a Research Development Coordinator, within our Governance team.

“Carlos has an unrivalled work ethic, diligence and attention to detail that makes him ideally suited to research. Furthermore, his courteous manner, ‘can-do’ attitude and positivity make him a popular and supportive member of staff. Carlos has significantly improved our data capture and analysis capabilities, especially concerning study set up times. As a result of his work, we are seeing our processes become more efficient and set-up times reducing. We have no doubts that Carlos will continue to develop within the coming years.”

We sat down with Carlos to find out a little more about his career journey to date, and how his work has helped enable faster, more efficient study set-ups and reporting. Read his story here: “BHP People – one team, one goal”.

By championing individuals including research nurses, statisticians, pharmacists and many others, BHP People also highlights the incredible diversity of careers in research and the essential contributions that these professionals make. As well as celebrating individual excellence, the initiative reflects the shared dedication of our diverse partner organisations to driving collaborative research.

Meet our previous winners

BHP People – “one team, one goal”

Written by Louise Stanley on 24/07/2025. Posted in BHP People, Birmingham Health Partners.

Carlos Chan, Research Development Coordinator at the Royal Orthopaedic Hospital, is the Trust’s first recipient of the BHP People recognition award.

We spoke to Carlos about his rapid progression from administrator to integral member of the ROH’s growing research team.

Q: Can you briefly run us through your career so far and how you came to work at ROH?

CC: My career began at a multinational nutrition science company in Hong Kong, where I worked as a brand manager and was heavily involved in new product development and commercial research. When I relocated to the UK I was keen to pursue a career in research, as it aligned closely with my personal values – especially the goal of contributing to better health for future generations. That’s when I had the opportunity to join the ROH Research Team.

I initially started as a band 2 administrator, which gave me invaluable insight into how the Trust operates and allowed me to build strong relationships across departments. My curiosity and desire to contribute more deeply led to a promotion to Data Manager where, with the support of a fantastic team, we significantly improved study delivery – streamlining referrals and communication for the ICONIC osteosarcoma study and hitting recruitment targets for the RADICAL pain management trial. We also achieved the highest response rate in the West Midlands for the 2023 NIHR Participant in Research Experience Survey (PRES).

I’m now working as a Research Development Coordinator, where I draw on my project management and liaison skills. Thanks to the collaborative culture and my earlier experience in delivery, we’ve streamlined processes and reduced setup times. It’s been a journey full of support and inclusion, and I’m excited for what’s ahead!

Q: In your current role, what are some of the tasks and duties you’re involved in most frequently?

CC: I’m responsible for coordinating research projects from the feasibility stage through to activation, and then managing amendments throughout the study’s life cycle.

I work closely with internal and external partners, including trial units, Principal Investigators, clinicians, research nurses, data managers, and pharmacy technicians. I also liaise with national bodies like the NIHR, HRA, and HSCNI to resolve governance queries.

My duties include performing local governance checks, securing cost approvals, managing risk assessments, and finalising contracts. This ensures that our site is ready and capable of opening each study.

Q: Have you experienced any particular challenges in your role, and how have you overcome them?

CC: Like any collaborative environment, we do encounter challenges – particularly when coordinating across departments or working through complex processes. When this happens, I always return to the principle of “one team, one goal.” I try to clearly identify our shared objective and assess what’s realistically achievable based on the resources available. We then openly discuss the pros and cons of different approaches. This collaborative decision-making ensures we move forward with the most effective solution, even if it’s not perfect for everyone involved.

Q: You’ve played a major role in improving data capture and reducing study set-up times – can you tell us more about the changes you introduced and the impact they’ve had?

CC: When I stepped into my current role, I noticed an opportunity to improve our study set-up tracking. I integrated our existing local governance processes into a custom-programmed Gantt chart which allows us to track every milestone and subtask, assign responsibilities, and monitor lead times. It has dramatically improved our visibility into each study’s progress. Additionally, we created a performance dashboard using PowerBI. This automation reduced the time required for reporting from several hours to just a few minutes. These tools have not only streamlined workflows but also enabled us to spot delays early and proactively address them – leading to faster, more efficient study setups.

Q: Can you tell us about some of the studies (past or present) that you’ve found particularly rewarding to be part of?

CC: One standout project is the ICONIC study, a UK-wide osteosarcoma research initiative which collects clinical and biological data to enhance our understanding of this rare cancer. As a surgical site without chemotherapy services, we had many referrals and patient transfers, which added complexity. Maintaining data integrity and a positive patient experience across sites was a challenge we tackled through strong collaboration with the trial unit and teams across the UK. The study is now at the end of recruitment, and I’m incredibly proud of our contribution.

More recently, we launched the FORENSIC trial, sponsored by the University of Oxford and led locally by Professor Adrian Gardner. It investigates whether lumbar fusion surgery is more effective than conservative care for persistent lower back pain. ROH was the first site to open and recruit for this trial, and I’m thrilled to see its early success.

Q: Looking ahead, what are your goals for your role in research development, and what areas of improvement or innovation are you most excited about?

CC: I hope to gain experience with a wider variety of studies, including device and pharmaceutical trials. One of the best things about working in research and development is the constant opportunity to learn and take on new challenges.

I also want to support the setup of more studies at ROH, enabling more clinicians and patients to engage in cutting-edge research that leads to better treatments and outcomes.

Above all, I hope every participant enjoys their research experience and feels encouraged to share it with others. By building a positive research culture, we can collectively advance healthcare and improve lives.

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