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Month: August 2021

Birmingham Health Partners plays key role in report calling for Government reform of regulation of medical devices

Experts within Birmingham Health Partners (BHP) have significantly contributed to a new independent report calling on the UK Government to reform the regulation of medical devices.

Lessons learned from issues around the regulation of diagnostic tests for COVID-19 which led to many substandard tests on the market, and opportunities for the UK to update the way it regulates medical devices now that it has left the EU, form part of the insights outlined in four reports by leading scientists from BHP.

BHP is a strategic alliance between the University of Birmingham, the West Midlands Academic Health Science Network, Birmingham Women’s & Children’s NHS Foundation Trust, and University Hospitals Birmingham NHS Foundation Trust, with members collaborating to bring healthcare innovations through to clinical application.

BHP’s Centre for Regulatory Science and Innovation was commissioned by the Regulatory Horizons Council (RHC), to produce four reports which have formed part of RHC’s ‘Report on Medical Devices Regulation’ calling for action from the government for regulatory reform of medical devices.  RHC is an independent expert committee that identifies the implications of technological innovation, and provides government with impartial, expert advice on the regulatory reform required to support its rapid and safe introduction.

The BHP reports were based on a combination of literature reviews, semi-structured interviews, a multidisciplinary stakeholder workshop and a post-workshop survey.  Stakeholders involved included leading experts from a range of policy and industry organisations such as the National Institute for Health and Care Excellence (NICE), Innovate UK, the Association of British HealthTech Industries (ABHI) and the British In Vitro Diagnostic Association (BIVDA), as well as patient and public contributors.

The reports produced by the BHP team focused on four critical areas defined through cross-stakeholder consultation undertaken by the RHC:

      • Report 1 – details a study examining lessons learned from COVID-19 in relation to regulations of in vitro diagnostics (IVDs – medical devices intended for use in diagnosis of disease or other conditions), and sets out the regulatory challenges such as the development of substandard diagnostic COVID-19 tests and lack of availability of reliable information during the pandemic. The report also sets out a series of recommendations on how the government could increase efficiency in test development and distribution in the event of a future infectious disease outbreak.
      • Report 2 – details a study consulting on the mitigations for the move to the United Kingdom Conformity Assessed mark from July 2023, as a result of the end to the use of the EU CE mark for medical devices. The cost and complexity of complying with the new UK regulation to medical device companies means companies may prioritise non-UK markets, potentially reducing availability and choice of medical devices for UK healthcare.
      • Report 3 – details a study looking at alternative routes to market for medical devices, probing the UK’s unique opportunity post-Brexit to update the way it regulates medical devices to promote patient outcomes, stimulate innovation, and ensure that the UK remains at the forefront of the global life sciences sector.
      • Report 4 – summarises ideas and evidence around the opportunities and risks for future UK regulatory reform of medical devices in four key areas: patient and public access to high quality medical devices; international investment and innovation; patient and user safety; and global standing in regulation of the life sciences sector.

Reports author Xiao Liu, a leading post-doctoral researcher at the University of Birmingham and an ophthalmologist at University Hospitals Birmingham NHS Foundation Trust, said: “With the UK’s exit from the EU, Europe’s transition of its regulatory framework, and the global urgency of the COVID-19 pandemic, now more than ever we need to identify how we can reform regulation so the UK can encourage international investment, innovation and improve safety of medical devices.”

Reports author Melanie Calvert, Professor of Outcomes Methodology and NIHR Senior Investigator at the University of Birmingham, and Director of the Birmingham Health Partners’ Centre for Regulatory Science and Innovation, added: “Among our findings is a clear need to build a patient-centred regulatory system that accelerates innovation, captures outcomes that matter to patients, protects patient safety and has increased patient engagement in medical device development and regulation.  We are proud to have made such a significant contribution to RHC’s report and we hope it will lead to wide-ranging reform of the regulation of medical devices.”

In the foreword of RHC’s report, Sir Bruce Keogh, Chair of Birmingham Women’s and Children’s NHS Foundation Trust which is part of BHP, says: “This report from the Regulatory Horizons Council is a timely call for action.  Importantly this report is firmly patient-centred: accelerating innovation, assuring safety, and increasing engagement of patients with the process of development and regulation.  The opportunities are enticing. Effective implementation of the recommendations will bring tangible economic benefits and enable our patients to benefit from the very best of UK and global innovations more rapidly than at present.”

Recommendations within RHC’s report are centred on:

      • Building a regulatory system for medical devices that works for patients
      • Increasing capacity to address present needs and emerging opportunities
      • International leadership and partnership in medical devices
      • Using medical devices as a template to help enable regulatory innovation that improves patient safety, system efficiency and UK growth
      • Building resilience and preparing for future threats

A spokesperson for the Regulatory Horizons Council (RHC) said: “We are very grateful to Birmingham Health Partners for the stakeholder engagement and four reports they produced, which provided a useful evidence base for our recommendations.”


      1. Lessons learned from COVID-19 in relation to IVD regulations –
      2. Mitigations for the move to the UKCA mark from 01 July 2023 –
      3. Alternative routes to market for medical devices –
      4. Opportunity and risks around future UK regulatory reform of medical devices –

New Birmingham-Roche collaboration targets new treatments for inflammatory bowel disease

A new £850k collaboration between Birmingham Health Partners (BHP) and global biotechnology leaders Roche is set to improve both diagnosis and care of patients with inflammatory bowel disease (IBD) by investigating promising biomarkers and inflammatory mechanisms in the search for new treatment targets.

IBD affects around 250,000 people in the UK in the form of ulcerative colitis and Crohn’s disease, and is characterised by an imbalance in gut bacteria which causes debilitating damage to the intestines.

Current treatments, which target the body’s immune response, are ineffective for the majority (around two-thirds) of patients, meaning many of them eventually have to undergo invasive surgery. These diseases affect mainly younger people of working age, and as the precise cause is not yet fully understood, there is a pressing need to identify non-surgical therapies which can improve quality of life.

As host to the largest IBD clinic in Europe, BHP founder-member University Hospitals Birmingham NHS Foundation Trust (UHB) will lead the new active translational research collaboration with Roche scientists, alongside BHP colleagues at the University of Birmingham’s Institute of Cardiovascular Sciences (ICVS) and Microbiome Treatment Centre. Newly-diagnosed IBD patients will be seen weekly at new clinics across sister UHB sites Queen Elizabeth Hospital Birmingham and Heartlands Hospital.

This unique patient cohort will provide invaluable biological samples taken before they begin treatment – allowing researchers to investigate biomarkers identified by Dr Asif Iqbal of ICVS. Dr Iqbal’s team will study disease pathology including the role of immune cells, the microbiome and metabolome in driving the various inflammatory mechanisms associated with IBD.

Professor Tariq Iqbal, Consultant Gastroenterologist at UHB and Director of the Microbiome Treatment Centre at the University of Birmingham explained: “IBD is an underfunded disease area and the potential benefits to patients which will arise as a result of this collaboration are likely to be lifechanging for many. Those participating in the trial will help build the first clinical resource of its kind from which we aim to promote earlier diagnosis and more effective treatments.

“Cross-discipline collaboration, facilitated by BHP, will be crucial in unlocking these advances as we tap in to expertise in specialties such as genomic sequencing as well as the University’s Microbiome Treatment Centre.”

Dr Asif Iqbal commented: “This project will demonstrate the power of combining basic science with translational clinical research for patient benefit. Through identifying targets in immune cells which drive this chronic inflammatory disease, we hope to develop a range of novel therapeutics.”

The collaborative research award of £844,163 from Roche funds two combined IBD projects from March 2021 to January 2023. UHB is aiming to recruit 60 patients to the study.

World-first trial to assess ‘life-extending’ cannabis-based drug for thousands with aggressive brain tumours

BHP founder member the University of Birmingham will co-ordinate a major UK trial to analyse the efficacy of cannabis-based drug Sativex in treating the most aggressive form of brain tumours.

The new phase II trial, to be funded by The Brain Tumour Charity, is to launch at 15 NHS hospitals and follows promising results from a phase I study in 27 patients. The phase II trial will assess whether adding Sativex (an oral spray containing cannabinoids THC and CBD) to chemotherapy could extend life for thousands diagnosed with a recurrent glioblastoma, which currently has an average survival of less than 10 months*.

In a phase I trial in glioblastomas earlier this year**, the drug — already used in treating multiple sclerosis — was found to be tolerable in combination with chemotherapy, with the potential to extend survival.

While the phase I study observed that more patients were alive after one year in the Sativex arm compared to the placebo arm, the study was not sufficiently powered to show survival impact.

The new three-year phase II trial (called ARISTOCRAT), led by Professor Susan Short at the University of Leeds and co-ordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham, is due to begin recruiting over 230 patients across all UK nations in early 2022, subject to sufficient funds being raised.

Having seen its income drop by over 25% last year due to the pandemic and been forced to pause its regular research grant funding programme, The Brain Tumour Charity has today launched an appeal to raise the £450,000 needed to open the trial as soon as possible.

Experts hope that, should the trial prove successful, Sativex could represent one of the first additions to NHS treatment for glioblastoma patients since temozolomide chemotherapy in 2007.

Glioblastomas are the most common and most aggressive form of brain cancer, with around 2,200 people diagnosed each year in England alone***. They are usually fast-growing and diffuse, with poorly-defined boundaries and thread-like tendrils that extend into other parts of the brain.

Almost all glioblastomas recur even after intensive treatment including surgery, radiotherapy and chemotherapy, and average survival is just 12-18 months from first diagnosis****.

Over the last decade, there has been significant global interest within both patient and scientific communities about the activity of cannabinoids in brain tumours, with the view that cannabinoid-based products may not only help relieve symptoms but could also have a positive impact on survival.

Several pre-clinical laboratory studies***** have suggested that cannabinoids THC and CBD may reduce brain tumour cell growth and could disrupt the blood supply to tumours – however, to date, clinical evidence that they could treat brain tumours has been limited.

In this new phase II trial, researchers will assess whether adding Sativex to the current standard chemotherapy treatment (temozolomide) could offer extra time to live for adults diagnosed with a recurrence of their glioblastoma after initial treatment.

The trial plans to recruit 232 participants across a minimum of 15 hospitals******: two thirds of the participants will be given temozolomide plus Sativex, while one third will be given temozolomide plus placebo*******.

Sativex, manufactured by GW Pharma, is an oromucosal spray containing 1:1 THC (Delta-9-tetrahydrocannabinol) and CBD (cannabidiol), with the active ingredients being absorbed in the lining of the mouth, either under the tongue or inside the cheek.

Participants will be asked to administer up to 12 sprays per day (or to the maximum dose they can tolerate if fewer than 12) of Sativex or placebo oral sprays. Participants will then undergo regular follow-up including clinical assessment (every four weeks), blood tests, MRI scans (every eight weeks), and they will complete quality of life questionnaires. This will also be one of the first trials to integrate with The Brain Tumour Charity’s app BRIAN.

The trial will measure whether adding Sativex to chemotherapy extends the overall length of patients’ lives (overall survival), delays the progression of their disease (progression-free survival) or improves quality of life.

Professor Pam Kearns, Director of the Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham, which is co-ordinating the trial, said: “Our mission at the CRCTU is to translate cutting-edge science and research into improved patient care by identifying novel therapies that will save lives. It is vital that trials like this, investigating the role cannabis or the chemicals in it can play treat cancer, are carried out.”

Principal Investigator, Professor Susan Short, Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds, said: “The treatment of glioblastomas remains 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.

“Cannabinoids 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. Glioblastoma brain tumours have been shown to have receptors to cannabinoids on their cell surfaces, and laboratory studies on glioblastoma cells have shown these drugs may slow tumour growth and work particularly well when used with temozolomide.

“It’s really exciting that we’re now at the point where we can run a definitive, well-designed study that will tell us the answer to whether these agents could help treat the most aggressive form of brain tumour. Having recently shown that a specific cannabinoid combination given by oral spray could be safely added to temozolomide chemotherapy, we’re really excited to build on these findings to assess whether this drug could help glioblastoma patients live longer in a major randomised trial.”

Dr David Jenkinson, Interim CEO at The Brain Tumour Charity, which is funding the trial, said: “We hope this trial could pave the way for a long-awaited new lifeline that could help offer glioblastoma patients precious extra months to live and make memories with their loved ones.

“With so few treatments available and average survival still so heartbreakingly short, thousands affected by a glioblastoma in the UK each year are in urgent need of new options and new hope.

“We know there is significant interest among our community about the potential activity of cannabinoids in treating glioblastomas, and we’re really excited that this world-first trial here in the UK could help accelerate these answers. The recent early-stage findings were really promising and we now look forward to understanding whether adding Sativex to chemotherapy could help offer life-extension and improved quality of life, which would be a major step forward in our ability to treat this devastating disease.

“But we also know that for many, this trial won’t come soon enough. In the meantime, while other cannabis-based products may help alleviate symptoms, there is insufficient evidence to recommend their use to help treat brain tumours. For anyone considering using cannabis-based products or other complementary therapies, it’s vital that you discuss these with your medical team first, as they could interact with other treatments such as anti-epileptic medicines or steroids.”

Stephen Lee, 62 from Leyland in Lancashire, took part in the phase I trial of Sativex in 2015 after his glioblastoma returned following initial treatment. Stephen was first diagnosed in 2010, just a few months after he had very sadly lost his older brother to the same disease. Stephen said: “My diagnosis was very sudden and was one of those days you never forget. Having had to leave work early with a severe headache and a stabbing pain in my right eye, my wife insisted that we go straight to hospital after what my brother had experienced.

“I was admitted that same day, had a scan and that’s when they identified it was a brain tumour. I had the operation the following week, and beforehand my wife and I agreed that we wanted to stay positive, to keep living our lives and to enjoy however much time we had together.

“I joined the early trial of Sativex in the hope that it could improve my quality of life, but I also thought it was important to do so as the chemotherapy and radiotherapy I was having had all been trialled by other people before it could be used safely. I thought it only right and proper that I followed in their footsteps and joined a trial to help prove a new drug which could benefit so many people in the future with a recurring glioblastoma.

“I took the oral spray 10 times a day, and it was easy as I could take it wherever we were going, even while out for dinner. While I don’t know whether I had Sativex or the placebo, since the trial finished in 2016, all my MRI scans have been clear.

“This new trial is so important as it will give people hope that there could be life beyond a glioblastoma diagnosis and that there are other treatments being trialled to support them to live their lives.”
Anyone affected by a glioblastoma can speak to The Brain Tumour Charity on 0808 800 0004.


*Twelves et al. A phase 1b randomised, placebo-controlled trial of nabiximols cannabinoid oromucosal spray with temozolomide in patients with recurrent glioblastoma. Br J Cancer 124, 1379–1387 (2021).

**The initial phase 1b trial, led by the same authors, was published in the British Journal of Cancer in February 2021. The study assessed the safety and potential effectiveness of adding Sativex to temozolomide for patients with a newly recurrent glioblastoma (GBM) – finding it could be tolerated, did not appear to interfere with temozolomide treatment and had the potential to improve survival. In the first part of the study, 6 patients received a personalised regime of Sativex of up to 12 sprays per day, alongside their temozolomide therapy – and the side-effects were recorded and reviewed. In the second part of the study, 21 patients were randomised to receive either Sativex with temozolomide (12 patients) or placebo with temozolomide (9 patients) for a total duration of 12 months. 10 out of 12 (83.3%) patients receiving Sativex were still alive after one year, compared to 4 out of 9 (44.4%) patients in the placebo arm.

***Greenberg et al. Incidence and outcomes for cerebral glioblastoma in England, Public Health England; Brodbelt, A., Greenberg, D., Winters, T., Williams, M., Vernon, S. and Collins, V.P. Glioblastoma in England: 2007–2011. Eur. J. Cancer 2015, 51, 533–542.

****The prior figure (‘less than 10 months’) is the average survival from the point of tumour recurrence following initial treatment, whereas the ‘12-18 months’ figure is the average survival from first diagnosis.

****Rocha et al. Systematic review of the literature on clinical and experimental trials on the antitumor effects of cannabinoids in gliomas. J Neurooncol, 2014. 116(1): p. 11-24; Dumitru, C.A., I.E. Sandalcioglu, and M. Karsak, Cannabinoids in Glioblastoma Therapy: New Applications for Old Drugs. Front Mol Neurosci, 2018. 11: p. 159; Torres, S., et al., A combined preclinical therapy of cannabinoids and temozolomide against glioma. Mol Cancer Ther, 2011. 10(1): p. 90-103.

******The recruiting centres include: Leeds General Infirmary; Guy’s and St Thomas’, London; Queen Elizabeth Hospital, Birmingham; Addenbrooke’s Hospital, Cambridge; Western General Hospital, Edinburgh; The Beatson, Glasgow; The Clatterbridge Cancer Centre, Liverpool; The Christie, Manchester; Queen’s Medical Centre, Nottingham; John Radcliffe Hospital, Oxford; Southampton General Hospital; Southmead Hospital, Bristol; Charing Cross Hospital, London; Velindre Cancer Centre, Cardiff, and the Royal Victoria Hospital, Belfast.

*******Both Sativex and the placebo are being provided free-of-charge for the duration of the trial by GW Pharma.