Tag: clinical trials

Clinical trial for new endometriosis treatment offers hope to millions of women

UK clinical trial for potential new endometriosis treatment, funded by Wellbeing of Women and the Scottish Government, offers hope to millions of women  

  • Researchers have been awarded nearly £250,000 by Wellbeing of Women and the Scottish Government to investigate if a drug called dichloroacetate is an effective treatment for endometriosis 
  • If successful, the drug could be the first ever non-hormonal and non-surgical treatment for endometriosis – and the first new treatment in 40 years  
  • Endometriosis is a debilitating condition that affects around 1.5 million women in the UK, yet it is chronically under-funded and treatment options are limited 
  • Wellbeing of Women and the Scottish Government are working in partnership to improve endometriosis treatment and care – a key aim of Scotland’s Women’s Health Plan.  

A clinical trial to study a potential new treatment for endometriosis is set to go ahead thanks to funding made possible by a partnership between leading women’s health charity Wellbeing of Women and the Scottish Government. 

Researchers from the Universities of Edinburgh, Aberdeen and Birmingham will set up and run the clinical trial, called EPIC2, which will involve 100 women with endometriosis in Edinburgh and London. They will investigate whether a drug called dichloroacetate is an effective pain management treatment for those with the condition.  

Endometriosis affects 1.5 million women and those assigned female at birth in the UK. It occurs when tissue similar to the lining of the womb grows elsewhere in the body, most commonly in the pelvic area. This tissue (known as endometriosis lesions) bleeds during a period but has nowhere to go – and causes inflammation, pain and the formation of scar tissue.  

Earlier research, funded by Wellbeing of Women, discovered that cells from the pelvic wall of women with endometriosis behave differently compared to those without the condition. Researchers from the University of Edinburgh found that these cells produce higher amounts of lactate, a chemical generated by the body to give us energy when there is a lack of oxygen. This creates an environment that supports the development and growth of endometriosis.   

When these endometriosis cells were treated with dichloroacetate, a drug previously used to treat rare metabolic disorders in children, lactate production decreased to normal levels and the size of the endometriosis lesions were reduced.  

The EPIC2 research team will build on this knowledge with their clinical trial to determine the optimum dose of dichloroacetate that will provide the most benefit, both in terms of tackling painful endometriosis symptoms and limiting side-effects. 

 

Dr Lucy Whitaker, Wellbeing of Women researcher and Clinical Lecturer in Obstetrics and Gynaecology at The MRC Centre for Reproductive Health, University of Edinburgh, is leading the research.

She said: “We’re grateful to Wellbeing of Women and the Scottish Government for giving us the opportunity to progress our research and hopefully move another step closer to the reality of a new, non-hormonal and non-invasive endometriosis treatment.  

“We know women with endometriosis desperately want more treatment options and better ways to manage the often-debilitating pain that it causes. Our research so far shows promising results that dichloroacetate can make a huge difference. I hope our new trial will confirm this and give women hope that new treatments and a better quality of life are on the horizon.” 

In the EPIC2 clinical trial, which will start recruiting this autumn, half of the women will receive dichloroacetate while the other half will be given a placebo. These will be allocated at random and taken for 12 weeks. Every woman will complete a series of questionnaires and give blood samples over the course of two-and-a-half-years. 

In a move towards personalised medicine, the dose of dichloroacetate for each woman will be determined by which version of a gene called GSTZ1 they carry. This gene is responsible for the speed at which dichloroacetate is metabolised by the body. Some variants do this more slowly than others, which could lead to a build-up of the drug in the bloodstream and increase the risk of side effects unless the dosage is tailored appropriately. 

Janet Lindsay, Chief Executive of Wellbeing of Women, said: “It is completely unacceptable that there have been no new treatments for endometriosis in 40 years. Too many women and girls are suffering from debilitating symptoms, such as chronic pelvic pain, fatigue and even fertility problems, and current hormonal and surgical treatments aren’t suitable for everyone. 

“Endometriosis is an extremely under-funded area of women’s health, so we are very pleased to partner with the Scottish Government and invest in medical research that could transform how the condition is treated for millions of women.

“Dichloroacetate has the potential to be the very first non-hormonal and non-invasive treatment for endometriosis, which will be truly ground-breaking.

With limited options currently available and no cure, advances like this are long overdue.” 

Maree Todd, Women’s Health Minister for Scotland, said: “Scotland is the first country in the UK to introduce a Women’s Health Plan, with endometriosis being one of its early priorities.

“The Plan includes several actions to help improve care and support for those with endometriosis, including a vital action to invest in further research to develop much needed improvements into treatment and management options for the condition. 

“I am pleased that we are jointly funding research with Wellbeing of Women into what could be the first non-hormonal treatment for endometriosis. It is a stepping stone to ensuring that those with endometriosis are given treatment choices that suit their needs.” 

Dr Ranee Thakar, President of the Royal College of Obstetricians and Gynaecologists, said: “It is really positive news that funding has been secured to research this potential new drug treatment.

“We know current endometriosis treatment options don’t work well for everyone, leaving many women with symptoms that can have a serious impact on their quality of life, affecting their physical and mental health.   

“We look forward to the results of this trial and its potential to improve the day-to-day lives of women and people living with endometriosis.” 

Clinical trial offers more than a glimpse into eye treatments

A new clinical trial researching treatment for patients with sight loss as a result of diabetes has shown a type of laser treatment to be both cost effective and non-invasive, offering the best option for patients and healthcare providers.  

There are currently several treatment options offered to people with Diabetic Macular Oedema (DMO), including two types of laser treatment and eye injections. DMO is the most common sight-threatening complication of diabetes, affecting over 27 million adults. This new research provides much-needed evidence to enable patients and healthcare professionals to be better informed on treatment options. 

DMO happens when blood vessels in the retina at the back of the eye leak, causing fluid build-up at the macula, which provides central vision. The leakage occurs when high blood sugar levels damage blood vessels. 

The severity of DMO is most often determined by measuring the thickness of the macula, which in-turn will determine the treatment offered. Patients with more severe DMO (with thickness of 400 microns or more) are treated with injections into the eye of drugs, known as anti-VEGFs.

Patients with mild DMO (with thickness of less than 400 microns) can be treated with macular lase, which can be standard threshold laser or subthreshold micropulse laser. The former produces a burn or scar on the retina.  The latter, which is a more recent technology, works without leaving a burn or scar or any type of visible change or mark on the retina. 

The research,  published in Ophthalmology, found that subthreshold micropulse laser, which does not create a burn on the retina, was effective in maintaining a patient’s vision. This also requires much less frequent visits to the clinic and is much more cost effective than treatment via eye injections, with eye injections costing almost ten times more than laser treatments. 

Professor Noemi Lois, Clinical Professor of Ophthalmology at Queens University and Honorary Consultant Vitreoretinal Surgeon at the Belfast Health and Social Care Trust and lead author on the study, explains: “The absence of a scar or burn following subthreshold micropulse laser led to some healthcare professionals to doubt its effectiveness compared to the standard threshold laser.

“However, our research addressed this by demonstrating that subthreshold micropulse laser is as good as standard threshold laser for helping people’s vision, reducing macula thickness, allowing people to meet driving standards, and maintaining their quality of life, both in general terms and for vision in particular.” 

The research team set out to compare both types of available laser treatment through a large randomised clinical trial, known as DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser SML). They recruited 266 patients across 16 NHS hospitals around the UK, with half receiving standard threshold laser and the other half receiving subthreshold micropulse laser. Unique to this trial, patients were involved in selecting the outcomes, including how driving standards would be met following treatment. At the end of the two-year trial, DIAMONDS found both laser treatments to offer equivalent benefits. 

The total cost of the care of patients enrolled in the trial (including the laser treatment and any other treatments required as well as the costs of the follow-up visits) over two years was similar for both patient’s groups. Over the two-year period, the cost per patient was just under £900 (£897.83) for patients in the subthreshold micropulse laser arm of the trial compared to £1125.66 for those in the standard laser arm.  

Professor Lois adds: “Some ophthalmologists advise patients with milder forms of DMO to have injections of anti-VEGFs, rather than laser, despite laser being less invasive and requiring less visits to the clinic.

“Laser treatment costs significantly less than eye-injections of anti-VEGFs. With an average of ten injections required over two years, the total cost of eye injections per patient amounts to approximately £8,500 for the drug alone. This is almost ten times the cost of subthreshold micopulse laser without taking into account additional costings such as staff time. 

“Until we published these findings, there was no robust evidence comparing these types of laser treatments. A lack of information led some healthcare professionals to favour standard laser over subthreshold micropulse laser. We now have robust evidence to show that both laser treatments are not only effective in clearing the fluid from the retina and maintaining vision for at least two years, but both are also cost-effective.”  

“Armed with this knowledge, it’s likely that patients will opt for micropulse subthreshold laser, which doesn’t burn the retina and is comparable to standard laser. Whilst we didn’t directly compare laser treatments to treatment via eye injections of anti-VEGFs, hopefully we have shown that laser is an effective treatment, while remaining much less invasive to the patient and much less costly to the NHS.”  

The research was funded by the Health Technology Assessment (HTA) of the National Institute for Health and Care Research (NIHR). 

Groundbreaking COVID-19 treatments to be fast-tracked through clinical trials

  • UK Government awards multi-million-pound funding to phase 1 clinical trial platform to fast-track innovative treatments
  • NHS patients could receive cutting-edge COVID-19 treatments in months rather than years
  • Move will bring in the world’s best researchers to trial treatments in the UK

The move marks a landmark development in COVID-19 research that could see results for brand new treatments in months rather than years, and will enable the government to get even more safe and effective treatments to the NHS rapidly through a more streamlined process.

Currently, the government funds phase 2 and 3 trials, such as the RECOVERY trial, which brought life-saving treatments dexamethasone and tocilizumab to the NHS. Phase 1 trials, usually arranged by the researchers, are the earliest stage of human trials that ensure treatments are safe and show a signal of benefit in treating a disease.

The funding has been awarded to expand the AGILE clinical trial platform and will allow for global innovators to progress cutting-edge treatments for COVID-19 through all 3 clinical trial phases in the UK, further protecting our supply chain. This in turn will attract the brightest of researchers and manufacturers from around the world to trial their medicines here in Britain.

Health and Social Care Secretary Matt Hancock said: “Today’s news will ensure all phases of clinical trials for new treatments are done in the UK, protecting our supply chain and securing the world’s best treatments for NHS patients at a much faster rate.

“I am immensely proud of the work that’s been undertaken by the brilliant scientists behind these treatments and the thousands of UK patients who have taken part in the trials.

“Together, we can continue to ensure the UK is one of the best countries in the world for trialling and deploying the most groundbreaking medical advancements for both COVID-19 and for dangerous diseases in the future.”

The funding has been awarded by the Medical Research Council (MRC) and co-funded though the National Institute for Health Research (NIHR).

A phase 1 trial is the earliest stage of human trials and is an essential first step that ensures treatments are safe. Once they pass phase 1, they then go into larger-scale phase 2 and 3 trials, such as RECOVERY or PRINCIPLE, before being made available on the NHS once proven to be effective.

The UK has proven throughout this pandemic to be a world leader in medical research and life sciences, stepping up quickly to the task of finding effective therapeutics for a completely new virus and supported by millions in funding by the UK government.

  • AGILE is a UK phase 1 and 2a clinical trial platform designed for rapid clinical evaluation of potential COVID-19 treatments
  • It is a collaboration between the University of Liverpool, the University of Southampton Research Unit, and other external partners
  • The innovative design of the trial means that multiple potential treatments can be evaluated in parallel and important testing stages can be completed in months rather than years, while maintaining a high level of safety at all times
  • Patients in early stages of COVID-19 infection will be recruited to AGILE from the community, in addition to patients who have been hospitalised with COVID-19
  • Treatments that show a signal of benefit in AGILE will be rapidly considered for advancement into later phase clinical trial platforms, such as PRINCIPLE and RECOVERY, where the effectiveness of treatments can be proven in greater patient numbers
  • The Therapeutics Taskforce will work with innovators to support them to progress their promising treatments through clinical trial phases
  • 4 treatments have so far been selected for AGILE:
    • EIDD-2801 (Molnupiravir), an antiviral
    • VIR-7831 and VIR-7832, both monoclonal antibodies
    • Niclosamide, an anthelminthic
  • Future treatments to enter AGILE will be selected by the UK COVID-19 Therapeutics Advisory Panel (UK-CTAP), who lead the process of reviewing and evaluating proposals for treatments to enter UK national trial platforms – read more about UK-CTAP and how drug proposals can be made
  • The UK was the first in the world to find a treatment which was proven to significantly reduce the risk of death: dexamethasone, found through the government-funded RECOVERY trial
  • On Thursday 11 February, RECOVERY also found the drug tocilizumab, when administered to hospitalised patients on oxygen with dexamethasone, further reduces the risk of death by 14% and length of hospital stay for patients by 5 whole days, on top of the benefits of dexamethasone – which will mean once rolled out to patients will significantly reduce pressures on the NHS
  • REMAP-CAP, which also received government funding, last month published results showing tocilizumab reduced the length of time in hospital by 10 days when administered to patients with 24 hours of being admitted to intensive care

Coronavirus: Valneva vaccine clinical trials get underway

  • Valneva begins first UK clinical trials for its promising COVID-19 vaccine, being developed in Livingston, West Lothian
  • the UK government has pre-ordered 60 million vaccine doses
  • follows a multi-million-pound UK government investment in Valneva’s manufacturing facilities, boosting its capacity to supply up to 250 million vaccine doses

Valneva has started UK clinical trials for its promising COVID-19 vaccine, currently being developed in Livingston, West Lothian.

Speciality vaccine company Valneva’s candidate will initially be tested on 150 UK volunteers at four National Institute for Health Research (NIHR) testing sites in Birmingham, Bristol, Newcastle and Southampton. These early phase 1 and 2 trials will show whether the vaccine produces a safe and effective immune response against COVID-19.

Should this early trial prove successful, larger clinical trials will be planned for April 2021 with over 4,000 UK volunteers testing 2 doses of the vaccine in 2 groups: those aged between 18-65 years and over 65s.

The UK government has already pre-ordered Valneva’s vaccine candidate and should studies prove it to be safe and effective, 60 million doses could be made available to the UK by the end of 2021.

This latest milestone follows a multi-million-pound up-front investment announced in August by the UK government and Valneva to expand its Livingston facility. This supports over 100 highly skilled jobs for technicians and scientists at the West Lothian site, while advancing Scotland’s vaccine manufacturing capacity.

Through this investment, if Valneva’s vaccine candidate proves successful, this permanent facility will potentially have the capacity to supply up to 250 million vaccine doses to the UK and internationally.

Valneva’s vaccine is the fifth to enter clinical trials in the UK, alongside Oxford/AstraZeneca, Imperial College London, Novavax and Janssen, whose studies are currently ongoing.

Business Secretary Alok Sharma, said: As we take the monumental steps in rolling out the first COVID-19 vaccine, we must remember that we need to have a range of vaccines available to protect the British public now and long into the future.

“Today we have more welcome news that life-saving clinical trials will begin across the country to test the safety and effectiveness of Valneva’s vaccine, which is being clinically developed right here in the UK.

“Having visited Valneva’s state-of-the art facility in the Summer, I have seen first-hand the incredible work our scientists and researchers are doing to develop this vaccine.

“Thanks to significant investment from the UK government, we are doing all we can to ensure our country has the capabilities in place to produce hundreds of millions of doses of this vaccine for the UK, and for those around the world.”

Secretary of State for Scotland Alister Jack said: “Today marks an important milestone not only in the UK’s fight against coronavirus but for the hundreds of staff at the Valneva facility in Livingston who have worked tirelessly over the last few months to develop this vaccine. This is a great example of the work of Scotland’s world-class life sciences sector.

“The UK government is doing everything it can to support all parts of the country throughout the pandemic including ordering and paying for vaccines for the whole of the UK. We are investing in Valvena’s manufacturing facility in Livingston, supporting hundreds of highly skilled jobs.

“With a number of other vaccines in development, this gives us all hope for the months ahead.”

The UK was the first country in the world to both procure and authorise the Pfizer/BioNTech COVID-19 vaccine, ordering 40 million doses – enough for around a third of the population. The UK was also the first country in the West to start a mass COVID-19 vaccination programme, which began on 8 December.

In total, the UK government has developed a portfolio of 7 different vaccine candidates and secured access to 357 million doses to date, putting the UK in the best position for a vaccine and increasing chances of finding vaccines that work for different people.

Chief Executive Officer of Valneva Thomas Lingelbach said: “Our teams have been working extremely hard to develop our differentiated vaccine candidate and I would like to thank them, as well as the UK government, for their dedication and support.

“While conducting our first clinical trials, we are already ramping-up our manufacturing capacities and commencing production at full-scale so that we can make the vaccine widely available across the world assuming the vaccine is safe and effective.

Interim Chair of the government’s Vaccines Taskforce Clive Dix: “Huge progress has been made in developing a successful COVID-19 vaccine. While this is very positive, we must remember there is no one size fits all approach, and we need to continue developing different types of vaccine so we can vaccinate the UK population.

“We believe that Valneva’s vaccine is promising and has the potential to tackle coronavirus now and into the future, which is why we have pre-ordered 60 million doses and are investing to help them expand their UK manufacturing facility. This will not only support them in manufacturing hundreds of millions of vaccines for the whole world but boost the UK’s resilience against possible future heath crises.

Chief Investigator for the Valneva study Professor Adam Finn said: “We are really pleased to be initiating this first-in-man phase 1 study in Bristol and continuing it in several other centres across the country in the New Year.

“This is a more traditional vaccine design than those that have been in the news recently, consisting of the whole SARS CoV2 virus that has been chemically inactivated. This kind of viral vaccine has been in widespread use for 60 years.

“Our team will be working hard through the Christmas holiday period to get the first participants enrolled and vaccinated. We are pleased to be adding further to the research already done via the NIHR in Bristol over recent months to test COVID-19 vaccines and we are really grateful to the many members of our community who continue to come forward and volunteer to take part in this important work.”

Lothian MSP, Miles Briggs said: “This is excellent news that Valneva, based in Livingston, are moving forward with clinical trials.

“The management of Covid-19 will take time and the Valneva Covid-19 vaccine will be part of the long term plan for beating the virus.

“I wish Valneva all the best with their clinical trials, so that a larger trial can be carried out early next year.”

Some of the volunteers taking part in Valneva’s clinical trials came through from the NHS Vaccines Registry, allowing the UK public to support the national effort to speed up vaccine research. Over 364,000 people have already signed up to the Registry, with more needed.

Additional information about volunteering for clinical studies can be found by visiting the NHS site to join the NHS Vaccine Research Registry.

The Registry was launched by the UK government in partnership with the NIHR, NHS Digital, the Scottish and Welsh governments and the Northern Ireland Executive in July. It aims to help create a database of people who consent to be contacted by the NHS to take part in clinical studies, to help speed up the development of a safe and effective vaccine.

Through the government’s Vaccines Taskforce, the UK has secured early access to 357 million doses of 7 of the most promising vaccine candidates, including:

  • BioNTech/Pfizer – Phase III – 40 million doses secured
  • Oxford/Astra Zeneca – Phase III – 100 million doses secured
  • Moderna – Phase III – 7 million doses secured
  • Novavax – Phase III – 60 million doses secured
  • Janssen – Phase III – 30 million doses secured
  • GSK/Sanofi – Phase I / II – 60 million doses secured
  • Valneva – Phase I / II – 60 million doses secured, with an option to acquire a further 130 million if the vaccine is proven to be safe, effective and suitable.

‘HELP IS ON IT’S WAY’

Green light for coronavirus vaccine rollout

Vaccinations to start next Tuesday in Scotland

The UK has become the first country in the world to approve a coronavirus vaccine for widespread use.

It’s understood that a public vaccination programme, using the Pfizer/BioNTech vaccine, could be under way as early as NEXT WEEK.

Health Secretary Matt Hancock said this morning: “2020 has been just awful but 2021 now looks so much better. I can now say with certainty that help is on it’s way. This will take time to roll out but I am confident now, that from Spring, from Easter onwards, things are going to be better and we wll have a summer that everybody can enjoy.

“We still face a difficult winter – but dawn is on the horizon.”

British regulator, the MHRA, says the jab, which offers up to 95% protection against Covid-19 illness, is safe for roll out next week.

A Department of Health and Social Care spokesperson said his morning: “The Government has today accepted the recommendation from the independent  Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s COVID-19 vaccine for use.

“This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.

“The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.

“The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.

“To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed.

“Further details will be set out shortly.”

TUESDAY START FOR VACCINATIONS IN SCOTLAND

Deliveries of the first coronavirus (COVID-19) vaccine to Scotland are expected to be made next week with injections being given from Tuesday 8 December.

The Medicines and Healthcare Products Regulatory Agency has confirmed that the vaccine developed by Pfizer and BioNTech has been authorised for use in the UK.

The vaccine, which must be stored at well below freezing, will be transported to 23 locations around the country in temperature controlled lorries.

Everyone being vaccinated will need two vaccines, between 21 and 28 days apart.

Those giving the vaccination to others will receive the injection first. The programme will then follow the independent advice received from the Joint Committee on Vaccination and Immunisation (JCVI), which recommends prioritising those with the greatest clinical need – including those aged over 80, and health and social care workers. The storage requirements mean logistics around delivery to care homes are more challenging and they are currently under consideration.

Health Secretary Jeane Freeman said: “Today’s announcement confirming that a safe and effective vaccine can now be used is the best news than any of us have heard about the virus since the pandemic began.

“As long as we receive the first doses of vaccine when we expect to, we will begin vaccinating from Tuesday next week.

“It is of course worth remembering that everyone will require two vaccines, with the second vaccine between 21 and 28 days after the first,  so even for those who are among the first, there will be very few completed until early next year.

“We intend to vaccinate the vaccinators first, followed by the priority groups recommended by the JCVI, however we also need to take account of  the conditions attached to the authorisation to supply the vaccine which will present challenges around transporting the vaccine to care homes and individual homes.

“We are therefore in the process of working through how we can ensure people in priority groups in those settings can be vaccinated.

“For all the difficulties that lie ahead, it should give us all real hope that the end of the pandemic is in sight.”

Landmark Clinical Trial on MND Begins in Glasgow

A groundbreaking clinical trial for motor neurone disease (MND) begins this week at the Queen Elizabeth University Hospital (QEUH) in Glasgow.
 
The pioneering trial MND-SMART is testing multiple drugs, rather than a single treatment at a time, and so aims to speed up the time it takes to find medicines that can slow, stop, or reverse the progression of MND.
 
The trial, based at the QEUH, will welcome participants from across the NHS Greater Glasgow and Clyde region which cares for the largest number of people living with MND.
 
Motor neurone disease (MND), also known as amyotrophic lateral sclerosis or ALS, is a progressive condition that causes muscle to waste away. It occurs when nerve cells called motor neurons, which send messages from the brain and spinal cord to the body’s muscles, stop working properly.
 
More than 1,500 people are diagnosed with MND in the UK each year. There is no cure and half of people die within two years of diagnosis.
 
MND-SMART is a pioneering clinical trial in its reach and design and is recruiting hundreds of people living with MND across the UK to take part in tests of potential treatments.  Unlike typical clinical trials which test a single treatment at a time, MND-SMART is testing multiple drugs and so aims to speed up the time it takes to find medicines that can slow, stop, or reverse the progression of, MND.


 
Dr George Gorrie, Consultant Neurologist and Lead for Motor Neurone Disease Greater Glasgow and Clyde, said:  “The MND-SMART trial launching in Glasgow is some good news at a time when there isn’t much around. 
 
“Ensuring the safety of people taking part in MND-SMART is the research team’s highest priority and we will follow all government requirements relating to COVID-19 and research.
 
“The pandemic and ensuring practices are COVID-19 compliant will impact how quickly people can be recruited to the trial but we are delighted to be able to start seeing participants.”
 
Those who have already registered online interest in the trial and who live in the Greater Glasgow and Clyde area will be contacted by the Glasgow trial team over the coming months to discuss taking part.
 
The trial was first announced in January and centres are due to open across the UK. Glasgow is the third such centre after Edinburgh and Dundee. 
 
The trial has been developed by people with MND and clinical trial experts from across the UK. The study is led by the Euan MacDonald Centre for MND Research at the University of Edinburgh.
 
Funding for the trial has been provided by the Euan MacDonald Centre, substantial private donations, MND Scotland and the My Name’5 Doddie Foundation.
 
For further information about the trial please visit www.MND-SMART.org

Cancer clinical trials back on track

Throughout the COVID-19 pandemic, patients across Lothian and the south-east of Scotland have continued to receive cancer treatment through a range of clinical trials.

Recently, with pandemic restrictions easing, more patients have resumed participation in cancer trials. And today (29 July) teams in the South East Scottish Cancer Research Network (SESCRN) are pleased to announce that any remaining trials that have been on hold in the region are all now able to reopen and would like to reassure patients that all trial options will be available to them.

The SESCRN teams – based in the Edinburgh Cancer Centre at the Western General Hospital – are also recruiting patients to take part in a series of new clinical trials.

Stefan Symeonides, a Consultant Oncologist and Clinical Lead for SESCRN, said: “COVID-19 presented us with significant challenges – and still does – but our teams have worked hard to minimise disruption caused by the pandemic.

“We’ve had to adapt how trials are delivered to patients, implementing a range of infection prevention and control measures required as a result of COVID-19, including social distancing. This enabled all patients already started on clinical trials for cancer treatment to remain on those trials.”

However, COVID-19 has restricted access to clinical trials for other patients who would have started treatment during the peak of the COVID-19 challenges.

“We share the concern and frustration experienced by these patients, which is why we are pleased that the recent easing of pandemic restrictions has allowed us to open trials back up again and widen patient access to other trials,” said Stefan Symeonides. “We are now able to reopen all remaining studies and we are excited to have started recruiting patients to new clinical trials.”

Dot Boyle, Network Manager with SESCRN, said: “Colleagues across the Network have made monumental efforts to continue clinical trials.

“For example, we were able to keep some trials running, where there were no safety concerns for patients and, since June, a range of other trials have resumed. We are currently engaged in over 100 clinical trials, half of which are open, with the other half now due to open imminently.

“In addition, every day, our teams work in collaboration with a range of partners to help facilitate more and more new trials, the first of which have opened, covering a range of different areas, including cancer of the bladder, breast and kidney.”

Professor Charlie Gourley, Professor and Honorary Consultant in Medical Oncology, Western General Hospital, said: “Clinical trials offer cancer patients new opportunities, either in addition to standard treatments, or after standard therapies have failed.

“They provide patients with hope and are a vital part of our armoury. The South East Scotland Cancer Research Network is rapidly reinstating these studies in order to offer our patients the best possible treatment options.”

Patients sign up for COVID-19 clinical trial

Over 100 patients are taking part in a clinical trial for COVID-19 treatment at NHS Greater Glasgow and Clyde. 

Patients in Glasgow have started receiving potential treatment for COVID-19 as part of a clinical trial at NHS Greater Glasgow and Clyde, with 120 patients recruited so far. The RECOVERY clinical trial is one of the fastest growing trials looking at potential treatment of COVID-19.

NHS Greater Glasgow and Clyde anaesthetists, respiratory physicians, emergency medicine consultants, pharmacy teams and nurses are leading the board’s involvement in this UK-wide study, funded by the UK government.

The RECOVERY trial aims to find effective treatment for coronavirus patients by testing pre-existing medicine. This includes steroids, antivirals and antimalarial agents. Antibiotics may also be added at a future amendment.

The trial is adaptive in design so treatments that show promise will be used more frequently.

All patients with COVID-19 that are treated at Queen Elizabeth University Hospital, Glasgow Royal Infirmary, IRH and RAH will be offered to take part in the clinical trial. It is a randomised-controlled trial where patients are given an active drug or standard care.

This is part of NHS Greater Glasgow and Clyde’s efforts to move forward research and development related to COVID-19 as fast as possible.

Dr Jennifer Armstrong, Medical Director of NHS Greater Glasgow and Clyde, welcomed the move and said: “Our teams have been incredible in rising up to the challenge of COVID-19.

“Not just in the care and treatment of patients but also their dedication to improving our knowledge of the virus through clinical trials. This means our patients are receiving the most up to date treatment available.”

Professor Julie Brittenden, Research and Development Director, NHS Greater Glasgow and Clyde, said: “I want to thank all of our staff for their efforts during this incredibly challenging time.

“Our research, development and innovation teams are working hard to improve the diagnosis and treatment of COVID-19.

“We’ve been able to rapidly mobilise our teams to take part in clinical trials like RECOVERY and this is a testament to their dedication to the cause.”

Dr Kathryn Puxty, Intensive Care Consultant at Glasgow Royal Infirmary, said: “As we care for more and more patients with COVID-19, we are seeing first-hand the need for effective treatment.

“We will be asking patients with COVID-19 who we treat in hospital, if they want to be involved in this study in the hope that we can improve care as quickly as possible.”

Working with partners across UK, Scotland is leading, enabling and delivering world-class COVID-19 research as part of coordinated efforts to gather reliable evidence.

Facilitated through the Chief Scientist Office (CSO) of Scottish Government and NHS Research Scotland, a single, national prioritisation process for COVID-19 research draws on expert advice across the UK. This prioritises studies which hold the most potential, prevents duplication of effort and ensures the resources and capacity of the health care system are not exceeded.

Charles Weller, General Manager, NHS Research Scotland said: “RECOVERY has been the fastest growing clinical trial in medical history; and a crucial part of our efforts to better understand and tackle COVID-19. I want to thank all teams for their commitment and professionalism to this national priority study.”

First MND drug trial in twenty years comes to Scotland

MND Scotland has announced the launch of the first Motor Neurone Disease (MND) clinical drug trial in Scotland, in over 20 years. MND Scotland, who is part-funding the study in Glasgow, is committing over £1.5 million into MND drug trials in Scotland, with MIROCALS being the first investment.   Continue reading First MND drug trial in twenty years comes to Scotland