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Central and North West Midlands Awarded Prestigious NIHR Commercial Research Delivery Centre

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

Birmingham Health Partners (BHP) has successfully led a bid to establish one of the UK’s new National Institute for Health and Care Research (NIHR) Commercial Research Delivery Centres (CRDCs) to expand access to innovative clinical trials and deliver life-changing treatments to some of the UK’s most underserved communities.

This transformative £7m investment will establish the Central and North West Midlands (C&NWM) Commercial Research Delivery Centre, hosted by BHP founding member Birmingham Women’s and Children’s NHS Foundation Trust (BWC), 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 new CRDC will make it easier for individuals across the C&NWM region to take part in research trials for cutting-edge healthcare treatments, partnering with drug companies to deliver treatment trials in a safe and responsible way. The new centre will also work closely with local businesses, patient groups and charities to help it reach a broad range of communities, including those that haven’t taken part in research before.

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 Lorraine Harper, Managing Director of Birmingham Health Partners and Director of the C&NWM CRDC, said: “This is an incredibly exciting opportunity to transform the health outcomes of our communities through world-class clinical research.

“By bringing together the expertise, resources, and passion of over 25 clinical and academic partners from across our region, we will create a thriving research ecosystem that not only delivers cutting-edge treatments but also makes clinical trials more accessible to all, including those in underserved populations. The NIHR’s investment will enable us to innovate and collaborate to improve healthcare in the Central and North West Midlands.”

Jeremy Kirk, R&D Director at BWC and Deputy Director of the CRDC said: “The primary objectives of the CRDC are to increase the number of trials in the region, boost participation from diverse communities, and speeding up the clinical trial process through streamlined workflows and innovative trial designs. BHP is already leading work to optimise academic trials and reduce bureaucracy, and so extending this programme into commercial trials is a natural next step.”

Professor Neil Hanley, Executive Director of Birmingham Health Partners and Pro-Vice-Chancellor and Head of the College of Medicine and Health at the University of Birmingham, said: “The success of the Central and North West Midlands CRDC bid is testimony to the deepening relationship between BHP’s partners. All of our academic and clinical member organisations were involved in developing our bid, which will bring tangible benefits to the wider partnership and help drive better health outcomes and economic growth to the region. It is yet more proof of the central importance of the health and life sciences sector to the region and country.”

Innovative approaches such as community-based trial locations, mobile research units, and digital technologies will ensure the CRDC reaches individuals who have never previously participated in research. Public involvement will be central to every stage of the Centre’s work, ensuring that its methods are inclusive, supportive, and effective in addressing local healthcare challenges.

Professor Lucy Chappell, Chief Executive Officer of the NIHR and Chief Scientific Adviser at the Department of Health and Social Care, said: “Clinical trials help improve lives. Boosting the NHS’s capacity to deliver commercial clinical research through these new Commercial Research Delivery Centres will support recruitment across all communities and bring innovative treatments to patients.

“The effects of these centres will be felt right across the four nations, bringing investment into the UK’s life sciences sector.”

£72 million investment

A total of 20 CRDCs are being established across the UK. In addition to the CRDCs in England, there will be four in Scotland, and a one nation approach in Wales and Northern Ireland. As part of the 10 Year Health Plan, the centres will shift clinical trials beyond large hospital trusts and into community settings, meaning those in underserved regions will now be able to participate in research, boosting access to new treatments in the trial stage.

This £72 million investment over seven years, beginning in April 2025, is awarded from the £400 million Voluntary Scheme for Branded Medicine Pricing, Access, and Growth (VPAG) Investment Programme and partly from NIHR in England.

The VPAG programme is a unique partnership between the UK Government and the pharmaceutical industry to boost the global competitiveness of the UK life science sector and stimulate economic growth. It will invest up to £300 million to bolster commercial clinical trial activity and help advance the delivery of new medicines and vaccines to patients.

The full list of C&NWM partners is:

  • HOST: Birmingham Women’s and Children’s NHS Foundation Trust
  • Aston University
  • Birmingham and Solihull Mental Health NHS Foundation Trust
  • Birmingham Community Healthcare NHS Foundation Trust
  • Black Country Healthcare NHS Foundation Trust
  • Dudley Integrated Health and Care NHS Trust
  • East Staffordshire PCN
  • Keele University
  • Midlands Partnership NHS Foundation Trust
  • Modality Partnership Limited
  • NHS Birmingham and Solihull Integrated Care Board
  • NHS Black Country Integrated Care Board
  • NHS Shropshire, Telford and Wrekin Integrated Care Board
  • NHS Staffordshire and Stoke-on-Trent Integrated Care Board
  • North Staffordshire Combined Healthcare NHS Trust
  • Sandwell and West Birmingham NHS Trust
  • Shrewsbury and Telford Hospital NHS Trust
  • Shropshire Community Health NHS Trust
  • Solihull Healthcare Partnership
  • The Dudley Group NHS Foundation Trust
  • The Royal Orthopaedic Hospital NHS Foundation Trust
  • The Royal Wolverhampton NHS Trust
  • University Hospitals Birmingham NHS Foundation Trust
  • University of Birmingham
  • Walsall Healthcare NHS Trust

(BHP member organisations in bold type).

One year in: Birmingham Health Partners drives progress in reducing bureaucracy in clinical trials

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

Birmingham Health Partners (BHP) is marking a year of transformative work on its Reducing Bureaucracy in Clinical Trials programme, which launched in November 2023 with the aim of establishing Birmingham a leader in delivering cutting-edge clinical research more efficiently. The ambitious initiative was established in response to the national drive for innovation, as outlined in the Lord O’Shaughnessy and Tickell reviews.

A year in, the programme has made significant progress toward streamlining clinical trial processes and developing pragmatic solutions, with active participation from our partner organisations. focusing on areas such as grants, contracting and site setup. Work is ongoing to: develop tools to help researchers navigate the complex research landscape more effectively, including piloting an e-request form; standardise template agreements across the partnership and establish standard operating procedures (SOPs) for pre-award grants; and create a consistent NHS-academic costing model.

Amy Smith, Senior Programme Lead, said: “This first year has been about laying a strong foundation for transforming how clinical trials are delivered across Birmingham. We’re particularly appreciative of the 100+ individuals who submitted responses to our survey over the summer, allowing us to understand the researcher experience and tailor our programme accordingly.

“By working collaboratively, we are making real progress in reducing the administrative burden on researchers and getting vital innovations to our patients faster. We’re excited to see what the next year brings as we continue to refine and expand this work – starting with a report on the results of our survey which we will be publishing soon, and a Town Hall event where investigators and researchers can learn more about our programme, ask questions and share their thoughts.”

Register for the online Town Hall event – Monday 9 December at 2.30pm – at the following link: https://forms.office.com/e/4Tu7Q4u1pg

This initiative comes at a pivotal time, with Lord Darzi’s independent investigation underscoring the essential role of research in preparing the NHS for the future and the newly elected Labour Government setting out bold ambitions for the NHS – including speeding up clinical trial recruitment, improving diversity, and reducing the time it takes to introduce high-impact innovations to patients. Other reforms aim to move away from hospital care to more services delivered in the community, digitising healthcare, and prioritising prevention rather than focusing only on treating illness.

At a national level, the Health Research Authority (HRA) has made strides by meeting or exceeding targets for trial setup times, and the transition from Clinical Research Networks (CRNs) to Research Delivery Networks (RDNs) on October 1st marked a shift towards research in broader health and care settings. Despite these advances, national performance indicators suggest there is still progress to be made, particularly in commercial trial setups and recruitment of first patients.

BHP remains committed to transforming Birmingham’s healthcare through high-impact innovation – delivering research that matters to patients.

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Birmingham opens Europe’s first pancreatic cancer mRNA vaccine trial

Written by Louise Stanley on . Posted in Cancer outcomes, Clinical trials, Experimental medicine.

Researchers at BHP founding-members University Hospitals Birmingham NHS Foundation Trust (UHB) and the University of Birmingham have opened a trial to study how messenger RNA (mRNA) cancer vaccines may be used to prevent recurrence of pancreatic cancer. The Queen Elizabeth Hospital Birmingham (QEHB) is the first hospital in Europe to recruit into such a trial.

Pancreatic cancer is among the deadliest cancers globally, with a survival rate beyond 10 years of just 5% in England (2013-2017). It is often only when the cancer has reached an advanced stage that physical symptoms appear, at which point it becomes more difficult to treat.

The trial aims to recruit patients undergoing surgery to remove pancreatic ductal adenocarcinoma (PDAC), an extremely aggressive disease that accounts for 90% of all pancreatic cancers.

Patients enrolled in the study will either receive an investigational cancer vaccine combined with chemotherapy (treatment group) or standard chemotherapy alone (control group).

In this investigational therapeutic cancer vaccine, mRNA is used to deliver the instructions for building several proteins (neoantigens) found in a person’s cancer. In doing so, the trial vaccine aims to train the immune system to recognise and attack the set of proteins (usually found on microscopic cancer cells) when it encounters it again.

Following surgery, samples of the patients’ tumour tissue and blood are sent to laboratories, to design and manufacture the investigational cancer vaccine. For the patients eligible for the trial, a mRNA-based cancer treatment is manufactured with mRNA specific to the proteins in that individual’s tumour.

This novel treatment approach is aimed at training the immune system to recognise and attack cancer cells, to potentially prevent cancer recurrence and increase the prospect of a patient being cured.

Dr Shivan Sivakumar, Principal Investigator of the trial, Associate Professor in Oncology at the University of Birmingham and Consultant Medical Oncologist at QEHB said: “We are incredibly proud that the Queen Elizabeth Hospital Birmingham is the first site in Europe to enrol a patient to this investigational pancreatic cancer vaccine trial. This achievement highlights Birmingham’s leading role in advancing cancer treatment, offering new hope for patients battling one of the most challenging cancers we face today.

“We recently also became the first site in Europe to open an immunotherapy study in cholangiocarcinoma (bile duct cancer), another deadly cancer. Birmingham is positioning itself to be a leading centre in Europe to test novel treatments for these hard-to-treat cancers and I find it humbling that patients in the Midlands have been able to enrol onto this trial, before anyone else in Europe.”

Professor Kiran Patel, Chief Medical Officer at UHB, which operates QEHB, added: “We are very fortunate to have exceptional infrastructure and world-class talent that positions us perfectly to lead in vital areas of cancer research.

“This trial showcases the expertise and dedication of our medical professionals, and the fantastic teams supporting them, who are at the leading edge of clinical research here in Birmingham.

“To be the first site to open in Europe, reaffirms our role as a national and international centre for cutting-edge oncology and highlights our commitment to improving patient outcomes through pioneering approaches.”

Jo Gray, Head of Research and Development Operations at UHB, said: “Through the National Institute for Health and Care Research (NIHR) Wellcome Trust Clinical Research Facility (CRF), we are able to provide expert care to patients receiving experimental therapies. Birmingham is the first site outside of North America to open and to enrol a patient onto this complex, early phase trial, that addresses an important need to identify better post-surgery treatments for pancreatic cancer.”

Professor Neil Hanley, Head of the College of Medical and Dental Sciences at the University of Birmingham, said: “This work epitomises why the University of Birmingham and its tremendous partnership with UHB is delivering life-changing impacts.

“Whilst such approaches were being investigated before 2020, we now know the power of mRNA vaccines from the COVID-19 pandemic; to tilt those discoveries from a time of tremendous challenge towards a much-needed world of new cancer treatments is inspiring for all of us.

“Birmingham is the ideal place to open this trial, with one of the leading pancreatic cancer units in the UK and serving a super diverse population. The chemistry between the university and hospitals is clear. By working as one team under the banner of Birmingham Health Partners, we are delivering the kind of cutting-edge research leading to transformational clinical care that befits Birmingham as an innovative city at the forefront of health and life sciences.”

Dr Chris Macdonald, Head of Research at Pancreatic Cancer UK, said: “For too long we have had so few treatment options for people with pancreatic cancer. Surgery is currently the only potential cure and yet, tragically, in 75% of cases the cancer reoccurs within a year. Finally, there is hope on the horizon.

“We are absolutely delighted that Queen Elizabeth Hospital Birmingham is the first site in Europe to enrol a patient to an individualised pancreatic cancer vaccine trial. We will be following the results with great interest, as the potential here cannot be understated. If this research proves successful, the vaccine could be a vital new weapon against the deadliest common cancer.”

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Birmingham launches pioneering trial to improve pregnancy outcomes for severe haemolytic disease

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

A pioneering study that took place at Birmingham Women’s Hospital has found an antibody that can improve the survival rate of unborn babies with rare, early-onset fetal anaemia, as a result of haemolytic disease of the fetus and newborn (EOS-HDFN).

Pregnant mothers have taken part in the UNITY trial, which has found that nipocalimab, an investigational, fully human, monoclonal antibody, has the potential to improve the survival rate of these babies.

BHP members the University of Birmingham (UoB) and Birmingham Women’s and Children’s NHS Foundation Trust (BWC) were a study site for a global, multicentre, open-label trial, in which nipocalimab was given for the treatment of pregnancies at high risk of severe EOS-HDFN, and evaluated safety, efficacy and the maternal metabolism of the monoclonal antibody.

Site investigator Mark Kilby, Emeritus Professor of Fetal Medicine at UoB and Honorary Consultant of Fetal Medicine at BWC said: “For mothers with severe HDFN the outcome not only of the condition but of the treatment, can be devastating. This is why the search for therapies to reduce the consequences of the maternal immune response has been focused on this cohort of women. The clinical study has found that nipocalimab is well tolerated and greatly increases the chance of unborn babies surviving severe EOS-HDFN, requiring less in-utero transfusion therapy.”

Haemolytic disease of the fetus newborn (HDFN), which is also sometimes referred to as Rhesus disease, is caused by a system of red blood cell antigens (most commonly of Rhesus D type) which raises the pathological antibody response in a pregnant person. These ‘pathological antibodies’ or alloantibodies can cross the placenta to the fetus and destroy its red cells, leading to progressive fetal anaemia and – if untreated – death of the fetus. 

Professor Kilby added: “These are fantastic results. In this group of pregnant women with severe HDFN, the medical management with nipocalimab has significantly reduced the need for early-onset in-utero fetal transfusion and improved the survival of these babies, reducing risks of miscarriage and stillbirth. Furthermore, and very importantly, nipocalimab seems to be well tolerated and safe for the mother and her unborn/newborn baby.   

“This research is a huge step forward for mothers who experience severe HDFN, as well as their partners, extended families, and of course, their children.”

Rosemary and Darren from Ireland were expecting baby Nessa when they took part in the clinical trial. Rosemary had had a previous in-utero transfusion for HDFN, and the couple had a child following treatment. Sadly, the couple lost a second baby after another in-utero transfusion. 

She was desperate to avoid another in-utero transfusion and was referred to the Fetal Medicine Centre at Birmingham Women’s Hospital eight weeks into her pregnancy after seeing news of the trial online and contacting her doctors at Dublin’s Rotunda Hospital. She had cell-free fetal DNA testing to confirm the baby was ‘suspectable’ to the antibodies she had produced. Rosemary then had maternal infusions of nipocalimab intravenously at weekly intervals from 14 to 35 weeks. 

Baby Nessa was born at 36 weeks weighing six pounds and 13 ounces and without the need for any IUTs.

Rosemary said: “When we were accepted onto the trial, we were both relieved and excited. Following the loss of our little girl Liliana, we were advised not to have any further pregnancies and we were devastated. This trial gave us hope of having another baby.”

“We were pregnant during the COVID lockdowns and as I was commuting from Ireland to Birmingham, it was a big worry but throughout our involvement in the trial, we felt supported, informed, understood and safe. We are forever grateful, the level of professionalism, compassion and empathy shown towards us is something we will never forget.” 

“Our two sons, Ollie and Joey now have a little sister, Nessa, who is a bubbly happy healthy four-year-old, full of mischief, giggles, and fun. To think the trial has given us what we believed was impossible, is a dream come true. To hear the trial has also given others living healthy children is fantastic. In a situation where we, like so many others felt was hopeless, to now know there is a treatment is like a miracle.”

Fitness app could transform care of rheumatoid arthritis patients

Written by Louise Stanley on . Posted in Clinical trials, Inflammation and chronic disease.

Researchers at BHP members Sandwell and West Birmingham NHS Trust and the University of Birmingham aim to transform the care of rheumatoid arthritis (RA) patients by developing an app which links to the Fitbit – a popular activity tracker.

The rheumatology medical team and researchers are leading the groundbreaking clinical trial to create the app which they hope will ease the pain of patients suffering from the crippling disease and provide extra support.

It’s called MISSION-RA which stands for MovIng to Support Sustained Improvement of Outcomes iN Rheumatoid Arthritis.

Sally Fenton, Chief Investigator for the study, said: “The app will be specifically designed for and by people with RA.

“This will be done in two ways. Firstly, a series of interviews, co-design studies and workshops will be carried out to develop the app. Then, artificial intelligence will be used within the app to provide personalised support for people living with RA, based on symptoms such as pain, fatigue and mobility. It is expected the app will be available to download for free so it can be used on a Fitbit in the future.”

RA leads to inflammation of the joints and surrounding tissues which causes flare ups – this is when symptoms become worse. One of the ways to help ease these episodes of pain can be through exercise, physiotherapy and occupational therapy.

Dr Sangeetha Baskar, Clinical Specialty Lead for Rheumatology and Principal Investigator for MISSION-RA explained: “Rheumatoid arthritis is an extremely painful, tiring, psychological and physically debilitating disease. Patients face countless challenges while doing basic daily activities such as dressing, cooking and walking and often become dependent on family members to perform some of their daily tasks. Through this innovative study and the mobile app, we are hoping to help patients increase their physical activity tailored for them and improve their quality of life.”

The first patient from the Trust has already been recruited into the study.

Ana Duarte, Clinical Research Practitioner (CRP) and also Associate Principal Investigator, said: “Overall, the MISSION-RA study has overcome our initial expectations. Patients are very keen and have enjoyed their experience so far. This has also been a great opportunity for the study staff which has led to progression in their careers. Most importantly, this we hope will place SWB’s R&D department and rheumatology team as international leaders in healthcare AI and machine learning.”

MISSION-RA is being delivered in partnership with the National Institute for Health and Care Research (NIHR) and National Rheumatoid Arthritis Society (NRAS).

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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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