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Author: Louise Stanley

Healthy Mum, Healthy Baby, Healthy Future – a year on, what progress has been made?

Written by Louise Stanley on . Posted in Maternal health.

“We cannot allow another 40 years to pass by with no new medicines for pregnant women” – Professor Katie Morris reflects on BHP’s Pregnancy Policy Commission and its work since the publication of the Healthy Mum, Healthy Baby, Healthy Future report in 2022. 

Most pregnant women will have a healthy pregnancy and give birth to healthy babies. An increasing number of women, however, will either have one or more health conditions before they become pregnant which require on-going treatment, or they may develop complications of pregnancy which require treatment.

The care of these women is severely hampered by a lack of suitable medicines, that we definitively know to be safe and effective for use in pregnancy or during breastfeeding. As a consequence, women and babies worldwide continue to become sick and die during or immediately after pregnancy. Despite this, over the last 40 years, only two new medicines have been approved for use in pregnancy.

Birmingham Health Partners‘ 2021 report, ‘Safe and Effective Medicines for Use in Pregnancy: A Call to Action’ highlighted the absence of research and information on the safety of medicines in pregnancy. It also drew attention to the urgent health needs of this neglected group both nationally and internationally, and the potential for saving and improving millions of lives globally.

As a direct response to this report the University of Birmingham and Birmingham Health Partners convened a Policy Commission focussing on the UK, canvassing knowledge and opinions from key parties including patient groups, the pharmaceutical industry, scientists, clinicians, NHS leaders, regulators and insurers. It aimed to explore the scale of the problems that are preventing the evaluation and development of safe medicines for use in pregnancy and collected recommendations for how these could be overcome.

The Commission report was published in May 2022 and entitled “Healthy Mum, Healthy Baby, Healthy Future.” It made a series of eight recommendations related to advocacy, widening participation of pregnant women in clinical trials, updating information on existing medicines, de-risking the insurance process for clinical trials, incentivising industry to develop pregnancy specific medicines, establishing a UK-wide network of research centres, improving the use of routine data, and appointing a UK steering committee to deliver these recommendations.

Over the last year, members of the Commission have been working to develop the steering group and engage with industry and insurance companies to drive forward these recommendations. There are challenges in driving this agenda forwards which can be broadly described as a de-prioritisation of women’s health, and particularly pregnancy, by industry and in the delivery of clinical trials related to workforce and capacity.

Without combined efforts from all stakeholders; public, scientific, clinical, industry, regulatory and governmental sectors, we will not see any progress. The first step will be through co-ordinated efforts via the recently formed steering committee and renewed approaches for engagement with industry and insurance providers.

We cannot allow another 40 years to pass by with no new medicines for pregnant women.

Together these stakeholders must advocate for change, respond to research and funding issues, and, where necessary, work to change official guidance or law to enable progress in this much neglected area.

The UK is well placed to become a global pioneer of maternal health research innovation. We have the health infrastructure of our NHS, with its birth-to-death records. Our medicines regulator is able to fast-track drug development and make changes to streamline the process, as well as working globally with Europe, the US and other regions. We are already a global hub for insurance – and we can support and build on this to add to our potential in becoming a leader in clinical studies for medicines in pregnancy.

There is an urgent need for action to address the underserved area of medicines use in pregnancy. Without it, women and babies will continue to die when they could be saved. They will continue to experience long-term health effects, disability and distress, which might be avoided. It is no longer ethical to deny pregnant women and their unborn babies access to safe, modern medicines that the rest of the population enjoys.

Professor R. Katie Morris MBChB, PhD, MRCOG, Professor of Obstetrics and Maternal Fetal Medicine
Director of Birmingham Clinical Trials Unit
Honorary Consultant Maternal Fetal Medicine, Birmingham Women’s and Children’s Hospital

Birmingham’s world-leading cancer trials unit gets £10m boost

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

A new £10m grant from Cancer Research UK will ensure that adults and children with cancer continue to benefit from world-class clinical trials led by the University of Birmingham.

The news has been hailed as a ‘major boost for patients’ by both clinicians and cancer survivors.

The Cancer Research UK Clinical Trials Unit (CRCTU) at BHP founder-member the University of Birmingham has already achieved significant progress in the treatment of cancer in the UK and internationally, including establishing new standards of treatment for the rare bone and soft tissue cancer, Ewing Sarcoma.

Scientists at the centre have also transformed the management of some types of prostate cancer and introduced treatment innovations for patients with blood cancers.

The new grant will allow researchers working on more than 100 national and international trials to continue developing safe and effective treatments as well as new tests for cancer over the next five years.

Professor Pamela Kearns, Director of the University of Birmingham-based CRCTU unit and children’s cancer expert, said:

“The renewal of funding for cancer trials in Birmingham is a major boost for our research here and we are delighted to continue working with research teams and patients to find new solutions in cancer care. Our clinical research enables us to translate discoveries from the lab and accelerate the improvement of cancer treatments, giving more patients the best chance of beating their disease.

“As a paediatric oncologist, I am particularly pleased this funding will allow our unique Children’s Cancer Trials Unit at Birmingham to continue to design and run clinical trials to improve the care of children with cancer.

“For example, with support from Cancer Research UK, we are leading International trials for children and young people with difficult to treat cancers like FaR-RMS; a trial testing innovative new treatments for rhabdomyosarcoma and the BEACON 2 trial, testing a range of new combinations of therapies for children and young people with a type of childhood cancer called neuroblastoma, at a stage where they have failed to respond well to standard treatments.”

The Birmingham CRCTU will combine strengths in innovative clinical trial methods with outstanding scientific and clinical expertise nationally and internationally to deliver new clinical trials, across all age groups over the next five years. The CRCTU will work alongside the Birmingham Experimental Cancer Medicine Centre, which is also funded by Cancer Research UK and the National Institute for Health and Care Research on trials to tackle more complex types of cancer and for cancers of unmet need.

Professor David Adams, Head of the College of Medical and Dental Sciences and Pro-Vice-Chancellor at the University of Birmingham said:

“The CRCTU is a jewel in the crown of our research portfolio across the University and I am delighted that with this latest funding we will continue to conduct internationally leading research to find better treatments and tests for cancer.

“Together with the ongoing funding for our Experimental Cancer Medicines Centre, the University is ideally placed to continue advances in cancer research which has a hugely significant role in society today. With unprecedented challenges for our NHS and after the effect that the pandemic has had on waiting lists and access to care, we need more than ever to have quick, effective and safe care for cancer.”

The team coordinates ground-breaking clinical trials across the UK and internationally, as well as regionally through Birmingham Health Partners (BHP) – a strategic alliance between seven higher education and health institutions including the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust and Birmingham Women’s and Children’s NHS Foundation Trust.

Improving outcomes – Francesca’s story

Cancer survivor Francesca Williams was one of 640 patients across Europe to benefit from a trial led by the Birmingham centre that has significantly improved outcomes for children and adults with Ewing Sarcoma.

Diagnosed with a tumour in her rib bone just weeks after her 27th birthday in July 2017, Francesca had 15 sessions of chemotherapy and five weeks of radiotherapy back-to-back over ten months. This was followed by major surgery at Heartlands Hospital in April 2018 to remove the remainder of her tumour and rebuild her chest wall using muscle from her back.

Despite going through medically induced menopause and having no time to store any eggs for fertility treatment, Francesca is expecting her first baby in July.

“I feel so lucky to have been part of the trial,” said Francesca, a 32-year-old English teacher who now lives in Austria.

“The worst thing for me was thinking I wouldn’t be able to have children so to find out I was pregnant last year was incredible. I’m really excited about becoming a mum.”

The European-wide trial EE2012, run by the University of Birmingham’s Cancer Research Clinical Trials Unit, tested the standard chemotherapy treatment plan against a new experimental treatment plan in children and adult patients from ten European countries.

The trial – a shorter treatment than the previous standard – found that six per cent more patients were cancer-free after three years, with fewer toxic side-effects. Results were so conclusive that the trial finished early in 2019 and the new treatment adopted as standard across Europe.

“I was very dubious about the trial to begin with but I’m so glad my dad persuaded me to go for it,” said Francesca. “I had no sickness from the chemotherapy so it’s great to hear that the treatment is now being offered as standard. That’s why I feel so passionately about supporting research. Without improvements like this I wouldn’t be here now.

“It’s such a deadly cancer and it is so aggressive, there isn’t the biggest window of opportunity for treatment. It affects a lot of young adults and children who can lose limbs if it’s found in an arm or a leg, but treatment can be successful if it’s caught early enough.”

BHP members join new Mission for mental health research

Written by Louise Stanley on . Posted in Clinical trials, Early diagnosis and detection, Mental health.

BHP members the University of Birmingham, Birmingham Women’s and Children’s NHS Foundation Trust and Birmingham & Solihull Mental Health NHS Foundation Trust, are part of the Government’s new Mental Health Mission – designed to develop radical new treatments for mental health conditions.

The £42.7M investment into research aims to improve the speed and accuracy of diagnosis and increase the use of new technologies, as well as novel and targeted treatment approaches for those with mental illnesses – including young people at Forward Thinking Birmingham (FTB), the city’s unique 0-25s Youth Mental Health Service.

The Mission will be delivered through the National Institute for Health and Care Research (NIHR) Mental Health Translational Research Collaboration, a UK wide network of leading investigators specialising in mental health research.

In Birmingham, £9.9 million in funding will enable the establishment of the Midlands Translational Research Centre of Excellence, co-led by the Universityof Birmingham with Birmingham Women’s and Children’s Hospitals and Birmingham & Solihull Mental Health NHS Foundation Trust, with reach across the Midlands through the five years’ funding.

Research will focus on increasing recruitment to new studies to test and validate treatments in early psychosis, depression and children and young people. We will work with people with lived experience to comprehensively understand the best way to test novel treatments. There are also plans to train and support a network of new researchers, partners, NHS staff and young people in the Midlands.

Professor Rachel Upthegrove, Professor of Psychiatry and Youth Mental Health at the University of Birmingham and Mental Health Research and Development Lead at Birmingham Women’s and Children’s NHS Foundation Trust, said: “We’re delighted that the Government is making such a significant investment in mental health research. This funding will allow us to increase and lead large-scale early intervention trials aimed at delaying or preventing the onset of severe mental illness, and its impact, with evidence-based treatments and support.

“The Centre will put research where we need it most, focusing on young, superdiverse, and deprived populations, which may be unfairly missing out on access to research.”

Teams at the Research Centre will work with individuals with lived experience to understand the best way to test treatments. There are also plans to train and support a network of new researchers, partners, NHS staff and young people in the Midlands.  

Building on the priority healthcare missions launched in November 2022 as part of the Life Sciences Vision, the Mental Health Mission will promote collaboration across different sectors to bolster research and attract further investment from industry and research organisations.

Nationally, the Mental Health Mission will be chaired by Kathryn Abel and Husseini Manji. In a joint statement, they said: “We are delighted to be working together to make the new Mental Health Mission a truly revolutionary force behind mental health research. We want the Mission to create tangible differences to the lives of patients, both in the UK and internationally. Between us, we bring a wealth of experience in mental health research and innovation, and a commitment to genuine collaboration with patients, industry and healthcare staff.

“Bringing together the public sector, patients and industry as equal partners, the Mission will work with the Office for Life Sciences and the National Institute for Health and Care Research (NIHR) to support the NHS and NIHR to capitalise on its size and scope, and on the depth of its data resources. Alongside additional investment in mental health research and infrastructure, the Mission will foster a step change in the way we think about mental health, mental illness and its treatment. This will support development of the critically needed treatments across the spectrum of mental illness.

“We want the UK to be the most attractive place to conduct robust, high impact mental health research, ensuring people have access to the best, and newest, treatments. We are confident that the Mission will be unique in its ability to convene and challenge national partners to make this happen.”

 

Cannabinoid-based drug trial for brain tumours launches in Birmingham

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

A major UK clinical trial of an oral spray containing cannabinoids to treat recurrent glioblastoma has opened in the UK. Funded by The Brain Tumour Charity and coordinated by the Cancer Research UK Clinical Trials Unit at BHP founder-member the University of Birmingham, the three-year phase II trial  will investigate whether combining nabiximols and chemotherapy can help extend the lives of people diagnosed with recurrent glioblastoma.

Anyone interested in this study, which is called ARISTOCRAT, should speak to their medical team first to ensure they are eligible to participate.

It will recruit more than 230 glioblastoma patients at 14 NHS hospitals across England, Scotland and Wales in 2023 including Birmingham, Bristol, Cambridge, Cardiff, Edinburgh, Glasgow, London, Liverpool (Wirral), Manchester, Nottingham, Oxford and Southampton.

Professor Pamela Kearns, Director of the Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham, which is co-ordinating the trial, said:

“ARISTOCRAT represents a significant step in our journey towards finding safe and effective treatments for the most aggressive brain tumours. By testing innovative combinations of drugs we hope to improve the outcome for this challenging disease.

“We’re immensely proud to be able to bring this trial to patients with the support of the Brain Tumour Charity and thanks to the generosity of all those who gave to the crowdfunding campaign.”

Glioblastoma is the most aggressive form of brain cancer with an average survival of less than 10 months after recurrence.

In 2021, a phase I clinical trial in 27 patients found that nabiximols could be tolerated by patients in combination with chemotherapy, and has the potential to extend the lives of those with recurrent glioblastoma.

Should the trial prove successful, experts hope that nabiximols could represent a new, promising addition to NHS treatment for glioblastoma patients since temozolomide chemotherapy in 2007.

In August 2021, a fundraising appeal by The Brain Tumour Charity, backed by Olympic champion Tom Daley, raised the £450,000 needed for this phase II trial in just three months, and Jazz Pharmaceuticals has generously agreed to provide nabiximols and matched placebo free-of-charge to patients on the ARISTOCRAT trial.

Participants will self-administer nabiximols or a placebo spray and will undergo regular follow-ups with the clinical trial team, including blood tests and MRI scans. This will also be one of the first trials to integrate with The Brain Tumour Charity’s app BRIAN.

Principal Investigator, Professor Susan Short, Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds, said:

“We are very excited to open this trial here in Leeds and very much look forward to running the study which will tell us whether cannabinoid- based drugs could help treat the most aggressive form of brain tumour.

“The treatment of glioblastomas is extremely challenging. Even with surgery, radiotherapy and chemotherapy, nearly all of these brain tumours re-grow within a year, and unfortunately there are very few options for patients once this occurs.

“Cannabinoid-based drugs have well-described effects in the brain and there has been a lot of interest in their use across different cancers for a long time now. Glioblastomas have receptors to cannabinoids on their cell surface, and laboratory studies on glioblastoma cells have shown these drugs may slow tumour growth and work particularly well when used with temozolomide.

“We now have the opportunity to take these laboratory results, and those from the phase I trial and investigate whether this drug could help glioblastoma patients live longer in this first-of-a-kind randomised clinical trial.”

How can I take part in the trial?

Your treating oncologist will be aware of the study if it is open in your hospital or can refer you to a treating centre if necessary. Please speak to your treatment team about eligibility for the trial.

For more information visit the ARISTOCRAT web page on the Cancer Research UK Clinical Trials Unit website. 

£2m study aims to improve early stage ovarian cancer diagnosis

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

A £2 million study will see an advanced test used at GP surgeries in the West Midlands to diagnose early-stage ovarian cancer – potentially saving thousands of lives a year.

The project involves BHP members Sandwell and West Birmingham (SWB) NHS Trust and the University of Birmingham collaborating with Walsall Healthcare NHS Trust (WHT) and primary care provider Modality, to offer a blood test called ROMA to patients experiencing symptoms of ovarian cancer.

Signs of the disease include bloating, stomach pain, needing to urinate more often and always feeling full.

If symptoms persist or are severe, frequent or out of the ordinary, women are urged to see their GP where – usually – a CA-125 blood test will be carried out, which has around a 50% detection rate of early-stage cancer.

However, the advanced ROMA test used during this trial at Modality-run GP services in Walsall, Sandwell and West Birmingham, will identify key markers of this particular disease at an earlier stage.

If a patient has tested positive, they will be referred to their local Trust to attend a new one stop clinic where they’ll see a consultant, undergo a specialist scan and then a further consultation where the results will be shared. They will be referred for further treatment if needed.

Speaking about the study, called SONATA (tranSforming Ovarian caNcer diAgnostic paThwAys), Sudha Sundar, Professor of Gynaecological Cancer at the University of Birmingham and Consultant Surgeon at SWB NHS Trust, said: “Ovarian cancer is rare and there is a need to increase the understanding and awareness of the symptoms associated with it among our population and GPs.

“We know that 90% of women diagnosed with ovarian cancer at stage one will survive, but this drops drastically to 15% if it is picked up during stage four.

“Research conducted with my team at the University of Birmingham found out that the ROMA test is significantly better than current tests (CA125 and ultrasound) used in both pre and postmenopausal women*.

“A previous study had found that the ROMA test detects up to 20% more early-stage cancers than the current test which only picks up 50% of early-stage cancers**. We are putting this research into practice by carrying out this trial.”

“With Modality-run GP surgeries trialling the ROMA test we will be able to establish if it is acceptable to patients and clinicians. By testing many samples across two large laboratories, we will be able to confirm whether the ROMA test has a higher chance of detecting this cancer earlier than the current CA-125 blood test used and whether implementing this across the NHS will be cost-effective.”

Leading on the project, Dr Aamena Salar, medical director for Modality Partnership Community Services, said: ‘Our aspiration is to transform the care of ovarian cancer by earlier detection and better outcomes for our patients.”

Nina Jhita, programme director at Modality, added: “This is true innovation; we (primary care) are delighted to collaborate with key system partners across the West Midlands to really make a difference to the lives of women while demonstrating how this solution can be scaled across the UK.”

The final part of the study will see 41,000 primary care samples sent to the Black Country Pathology Service and South Tyne and Wear laboratories to accurately establish whether using the ROMA test rather than CA125 will be cost effective for the NHS. The results from the study, funded by the NHS Cancer Programme and the Small Business Research Initiative, will be analysed and used to change the way this cancer is diagnosed in the future.

Professor Sundar added: “It’s an exciting study which is a great example of integrated working between all the organisations involved. We are looking forward to finding out the results so that we can change the way this cancer is detected in the future and drastically improve survival rates.”

*Abstract published in July 2023: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011964.pub2/full
**Further information can be found here: https://pubmed.ncbi.nlm.nih.gov/27540691/

UHB launches mRNA cancer vaccine trial for colorectal cancer

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

BHP founder-members University Hospitals Birmingham NHS Foundation Trust (UHB) has become the UK’s first site to launch the BioNTech Messenger RNA (mRNA) cancer vaccines trial which aims to recruit 10,000 people across the UK.

Launching within the NIHR Clinical Research Facility (CRF) at Queen Elizabeth Hospital Birmingham, mRNA vaccines are one of the most exciting experimental developments to emerge from the COVID-19 pandemic – with strong indications that they could become powerful anti-cancer treatments.

Traditionally, vaccines use dead or weakened viruses to stimulate the immune system into recognising or creating harmless antibodies, so when exposed to the real virus, the body is better placed to fend off an overwhelming infection. mRNA is a genetic material that copies instructions found in DNA, using them to make proteins that carry out functions in the body.

Efficiency and speed are part of the appeal of mRNA vaccines. The manufacture of traditional inactivated virus vaccines takes months as scientists are required to grow these on a huge scale, inactivate the virus, and then formulate it to administer in the general population. mRNA vaccine manufacture only requires the right sequence of genetic instructions.

At UHB, this mRNA trial aims to recruit patients with high-risk stage II and stage III colorectal cancers where there is no standard of care treatment to offer the patient following surgery. Each mRNA vaccine delivered will be personalised to the individual patient.

Around 42,900 people are diagnosed with colorectal cancers in the UK each year. It is the 4th most common cancer in the UK. In Birmingham and Solihull alone, almost 700 people are diagnosed with a colorectal cancer each year.

Dr Victoria Kunene, Consultant Oncologist and Principal Investigator for the trial at UHB, said: “I am really very excited that we have been able to lead the way in setting up this arm of the trial, and am looking forward to being part of the wider vaccine program at UHB.

“We are proud to have an impressive team aptly capable of safely delivering these studies here in the West Midlands, and it is a real pleasure to be part of this transformational trial.”

Prof Simon Ball, Chief Medical Officer, said: “A diagnosis of cancer is devastating for patients and their families; this trial represents a monumental step forward in providing not just hope, but a real promise of delivering better outcomes for patients with colorectal cancer, for whom there is not always a standard of care treatment available following surgery.

“Our research teams, supported by the NIHR, have a proven, distinguished track record in delivering vital trials that make significant contributions to medical and scientific discovery with the patient at the very heart; we’re immensely proud to be able to play a strong part in this here in the West Midlands.”

Participants randomised to receive the study treatment will receive 15 treatments of over one year, followed up for at least 36 months. The treatment is, in essence, a personalised medicine for post-operative patients with high-risk stage II/III colorectal cancer, for whom there is no standard of care treatment and involves the development and testing of an individualised cancer treatment called RO7198457.

UHB is the first site open for this trial – a multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457, versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection.

‘Individualised’ means that the treatment is made individually for each participant according to their unique cancer. This is then tested for mutations which create a unique fingerprint. The goal of an individualised cancer treatment approach is to help train the immune system to recognise and attack cancer cells.

Participants who are randomised to the observation group will be followed up for at least 48 months and visit the research site every three months. Care is provided to ensure safety during trial participation, including an informed consenting process, regular follow up where biomarkers and all reported outcomes are collected and analysed.