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Found 61 results
  1. News Article
    A new treatment to protect babies against a common and potentially dangerous winter virus has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). Respiratory syncytial virus (RSV) is the main reason children under five end up in hospital. In a normal winter, RSV mostly causes coughs and colds which clear up in a couple of weeks - but it can be particularly serious in infants under the age of two, causing severe lung problems such as bronchiolitis and pneumonia. Every year, about 29,000 babies need hospital care for RSV and most have no other health issues beforehand. The new antibody treatment, called nirsevimab, from Sanofi and AstraZeneca, has already been shown to reduce lower respiratory tract infections caused by RSV by 74.5% in trials involving 4,000 babies. It works by preventing RSV from fusing to cells in the respiratory tract and causing infections. But it still needs more research in larger numbers of babies before it can be used on the NHS. Researchers now plan to investigate whether it can cut the number of babies needing hospital care for RSV, and are urging parents to sign up to their study. The study is open to newborn babies and those up to 12 months old. Only one visit for the antibody injection is needed, and follow-up sessions happen via an app. Co-study leader Dr Simon Drysdale, consultant paediatrician in infectious diseases at London's St George's Hospital, said the treatment could eventually be given at birth to offer protection for the first months of life, or during routine immunisations at two months old. Read full story Source: 10 November 2022
  2. News Article
    The coronavirus vaccine candidate being developed by AstraZeneca and Oxford University induces a strong immune response and appears to be safe, according to preliminary trial results. The early stage trial, which involved 1,077 people, has found that the vaccine trains the immune system to produce antibodies and white blood cells capable of fighting the virus. It also causes few side effects. Professor Sarah Gilbert, co-author of the Oxford University study, described the findings as promising but said there “is still much work to be done before we can confirm if our vaccine will help manage the Covid-19 pandemic”. The results came as the UK secured 90 million doses of other promising Covid-19 vaccines, while clinical trials of a new inhaled coronavirus treatment showed it significantly reduced the number of hospitalised patients needing intensive care. Read full story Source: The Independent, 21 July 2020
  3. News Article
    Low dose dexamethasone reduces deaths in patients hospitalised with COVID-19 who need ventilation, according to preliminary results from the RECOVERY trial. The drug was also found to reduce deaths by one-fifth in other hospitalised patients receiving oxygen only, but no benefit was seen among COVID-19 patients who did not need respiratory support. The chief investigators from the University of Oxford trial said that the findings represent a “major breakthrough” which is “globally applicable” as the drug is cheap and readily available. Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and a chief investigator on the trial, added, “This is the only drug that has so far been shown to reduce mortality, and it reduces it significantly. It is a major breakthrough.” Read full story Source: BMJ, 16 June 2020
  4. News Article
    A trial has been launched in the UK to test whether ibuprofen can help with breathing difficulties in COVID-19 hospital patients. Scientists hope a modified form of the anti-inflammatory drug and painkiller will help to relieve respiratory problems in people who have more serious coronavirus symptoms but do not need intensive care unit treatment. Half the patients participating in the trial will be administered with the drug in addition to their usual care, while the other half will receive standard care to analyse the effectiveness of the treatment. Read full story Source: The Independent, 3 June 2020
  5. News Article
    Selected NHS coronavirus patients will soon be able to access an experimental treatment to speed up their recovery, with the health secretary Matt Hancock suggesting it is probably “the biggest step forward’’ in medication since the beginning of the COVID-19 crisis. The anti-viral drug remdesivir will be made available to patients meeting certain clinical criteria to support their recovery in hospital. The drug is currently undergoing clinical trials around the world, including in the UK, and peer-reviewed data showed it can shorten the time to recovery by about four days. Treatment will initially be prioritised for patients who have the greatest likelihood of deriving the most benefit, according to the Department of Health and Social Care (DHSC). Satisfied the drug can help boost recovery, the government’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the use of remdesivir through its early access to medicines scheme. The experimental anti-viral drug was granted emergency authorisation to treat Covid-19 in the US by the Food and Drug Administration earlier this month. Read full story Source: The Independent, 26 May 2020
  6. News Article
    The World Health Organization has said it will temporarily drop hydroxychloroquine — the malaria drug Donald Trump said he is taking as a precaution — from its global study into experimental coronavirus treatments after safety concerns. The WHO’s director-general Tedros Adhanom Ghebreyesus said in light of a paper published last week in the Lancet that showed people taking hydroxychloroquine were at higher risk of death and heart problems than those who were not, it would pause the hydroxychloroquine arm of its solidarity global clinical trial. “The executive group has implemented a temporary pause of the hydroxychloroquine arm within the solidarity trial while the safety data is reviewed by the data safety monitoring board,” Tedros said on Monday. “The other arms of the trial are continuing,” Read full story Source: The Guardian, 25 May 2020
  7. News Article
    Drugs that could relieve the symptoms of coronavirus in vulnerable patients and help them avoid admission to hospital are to begin trials in homes across the UK. The experiment, led by a team at Oxford University, seeks to test pre-existing treatments for older people in the community who show signs of the disease. Known as Principle, or “Platform Randomised trial of interventions against Covid-19 in older People”, it is the first to take place in primary care settings such as health clinics. Read full story (paywalled) Source: The Independent, 12 May 2020
  8. News Article
    Trials have begun in the UK to test the effectiveness of blood plasma transfusions in treating patients suffering from COVID-19. NHS Blood and Transplant (NHSBT) have started delivering the first units of convalescent plasma, which contains the antibodies of people who have recovered from coronavirus, to hospitals in England. In total, 14 units have been supplied to Guy’s and St Thomas’ NHS Foundation Trust, Imperial College Healthcare NHS Trust and University Hospitals Birmingham NHS Foundation Trust. The first transfusions have been administered, NHSBT confirmed on Wednesday, though the efficacy of the treatment will not be known until the trial ends. Seven hospitals are currently taking part in the trials, which will assess a patient’s speed of recovery and chances of survival, with more expected to join in the coming months as the number of people eligible to donate blood plasma increases. As of Tuesday, more than 6,500 people had signed up while around 400 donations had been made. Gail Miflin, Chief Medical Officer for NHS Blood and Transplant, said: “We’re delighted the first patients are receiving convalescent plasma transfusions thanks to the generosity of our donors." Read full story Source: The Independent, 7 May 2020
  9. News Article
    Southampton researchers are trialling an inhaled drug that could prevent worsening of COVID19 in those most at risk. The trial, led by Tom Wilkinson, Professor of Respiratory Medicince in the Faculty of Medicine and a consultant in respiratory medicine at University Hospital Southampton, will involve 100 patients at Southampton and up to ten other NHS hospitals taking part. Those patients will receive the best current COVID19 care, whilst inhaling either a placebo or SNG001, a special formulation of the naturally occurring antiviral protein interferon beta 1a (IFN-β), for 14 days. The trial will be undertaken with Synairgen, a drug development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. Professor Wilkinson said, “COVID19 cis presenting a major challenge to vulnerable patients, the health service and wider society whilst a vaccine will be key, that could some time away. Right now we need effective frontline treatments to give doctors the tools to treat the most vulnerable and to help patients recover quickly as the pressure on health systems mounts." Read full story Source: University of Southampton, 18 March 2020
  10. Content Article
    In this blog, we take a look at why women have been historically underrepresented in clinical trials and medical research, and the ongoing implications this has on medication safety for women.
  11. Content Article
    Assessment of patient-reported outcomes (PROs) provides valuable information to inform patient-centered care, but may also reveal 'PRO alerts': psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management, Kyte et al. conducted a national survey of personnel involved in clinical trials with a PRO endpoint.
  12. Content Article
    The recording of harm and adverse events in psychological trials is essential, yet the types of harm being captured in trials for talking treatments involving children and young people have not been systematically investigated. The aim of this review from Daniel Hayes and Nur Za’bawas was to determine how often harm and adverse events are recorded in talking treatments for children and young people, as well as the metrics that are being collected.
  13. Content Article
    Guest blogger for PLOS Blogs 'Speaking of Medicine', Trish Greenhalgh, suggests its time for less research and more thinking.
  14. Content Article
    In this article, Robert Greene, Founder and President of HungerNdThirst Foundation, explains why patient advocacy is a vital aspect during the entire clinical trial process. He discusses how a patient advocates help patients communicate with their healthcare providers in order to make an informed decision about their health care, the positives and negatives of participating in clinical trials and how building trust and collaboration between patients, patient advocates, other stakeholders, and clinical trial professionals is important.
  15. Content Article
    In this podcast episode, host Aaron Harmon speaks to Dr Neil Vargesson, chair in developmental biology at the University of Aberdeen, about the importance of Good Laboratory Practice (GLP) and why pre-clinical studies are key to keeping people safe. They discuss the history of Primodos, a hormone-based pregnancy test that was given to women between 1959 and 1978. It was developed before GLP and before standardised testing for teratogenesis (causing birth defects). There are data that suggests Primodos caused birth defects, but more questions remain.
  16. Event
    until
    The Health Research Authority (HRA) rounds off Make it Public Week with a panel discussion, chaired by Professor Sir Terence Stephenson, HRA Chair. Sir Terence will be joined by a panel representing different parts of the research sector, who will revisit and reflect on the key topics of discussion during the week. We will also be looking forward and at what we – as individuals, organisations, and the sector as a whole – can do next to make research transparent from start to finish, and how we can keep the conversation around research transparency going. Participants can submit questions to the panel ahead of the meeting or live on the day using Slido. You can submit a question in advance when registering for the event. Book now to reserve your free space
  17. Event
    until
    The Health Research Authority is holding its first research transparency week. The effectiveness and relevance of research is improved when opportunities to be involved in research are made more visible, open and accessible to the public. This is because it gives a study the best chance to involve the full range of people who will benefit from the outcomes of research. By having research opportunities more publicly available, researchers will be able to recruit and retain a wide, diverse range of research participants. As a result of increased diversity and better opportunities to access diversity and better opportunities to access research for more people, research will be more relevant, effective, trusted and transparent. At the same time, health professionals, commissioners, researchers, policy makers and funders can use research findings to make informed decisions, which will enhance public trust in research evidence and enhance public accountability. It is equally important to have an awareness and understanding of potential barriers that may restrict members of the public getting involved in research. Identifying these challenges and putting measures in place to counter them is therefore essential in the delivery of transparent research. This will be a two-hour online workshop, chaired by the co-Chairs of the Make it Public campaign group, Matt Westmore, Chief Executive of the HRA, and Derek Stewart, public contributor. The objective for attendees of this workshop will be to work together in facilitated small groups to explore this theme, and produce a set of 'top tips' to support best practice for those active in research. There will also be a short panel discussion, where attendees can hear directly from the study leads and research participants of studies, as well as organisations, working creatively and progressively in this area. NIHR Be Part of Research Patient Research Ambassador scheme, Maidstone and Tunbridge Wells NHS Trust Register for the workshop
  18. Event
    until
    The Health Research Authority is holding its first research transparency week. This workshop will look at the importance of publishing summary results of trials We believe that publishing summary results and data – not just of trials, but of all research – in an open, accessible and public way is a key factor in ensuring research is transparent. Publishing results in a peer-reviewed journal is not always achievable, and findings published in this way may not be accessible to the public. Making the results of research studies public and as easy to access as possible helps builds trust and accountability, whilst ensuring participants are protected from unnecessary studies. It is also a process that helps ensure research funding is maximised by avoiding duplication. This will be a two-hour online workshop, chaired by the co-Chairs of the Make it Public campaign group, Matt Westmore, Chief Executive of the HRA, and Derek Stewart, public contributor. The objective for attendees of this workshop will be to work together in facilitated small groups to explore this theme, and produce a set of 'top tips' to support best practice for those active in research. There will also be a short panel discussion, where attendees can hear directly from the study leads and research participants of studies, as well as organisations, working creatively and progressively in this area. Abbvie Chief Scientist Office Scotland F1000 ISRCTN Registry Register for the workshop
  19. Community Post
    Hi there, I represent a team of researchers in Reading, who are submitting ethical approval for a project investigating pain research and knee surgery. Part of this process is receiving feedback from an NHS ethics committee and addressing this for the benefit of the science, patients and clinicians involved. One suggestion they have made is that we involve patients within the review of our information sheets, which detail the procedures (both medical & research) that they may consent to. There is no requirement of expertise or experience from any patient who wishes to be involved, we are just very eager to make sure our information is clear, free of jargon and doesn't come across as confusing or intimidating. The committee have indicated this is an optional recommendation, but it is one that I am very keen to engage with. As it's optional, we are unable to shift our deadline for this, and I would unfortunately need the documents reviewed and submitted by Thursday 26th November. If this is something that anybody would be willing to help us with, I'd be very grateful. One information sheet is 2 pages, and the other is 7 pages, if this offers a good idea of how much time it may require. My hope it it would take no more than 30 minutes. If you are able to volunteer your time, please contact me on rich.harrison@reading.ac.uk, and I will forward you the documents for your review. Once again, thank you in advance! Richard
  20. Content Article
    Investigations suggest that, in some fields, at least one-quarter of clinical trials might be problematic or even entirely made up. This article in Nature looks at the findings of researchers who have been studying clinical trials and calling for greater regulatory scrutiny. It particularly examines the work of John Carlisle, NHS anaesthetist and editor at the journal Anaesthesia, who scrutinised over 500 studies with randomised controlled trials, over a period of three years. Carlisle found that 26% of the papers had problems that were so widespread that the trial was impossible to trust, either because the authors were incompetent or because they had faked the data. He called these ‘zombie’ trials because they had the semblance of real research, but closer scrutiny showed they were masquerading as reliable information.
  21. Content Article
    In February 2023, the government commissioned an independent review to offer recommendations on how to resolve key challenges in conducting commercial clinical trials in the UK and transform the UK commercial clinical trial environment. The review sets out 27 recommendations, including both priority actions to progress in 2023 and longer-term ambitions for UK commercial clinical trials. The review was conducted by Lord James O’Shaughnessy, Senior Partner at consultancy firm Newmarket Strategy, Board Member of Health Data Research UK (HDR UK) and former Health Minister, who was appointed as review Chair. During the review, Lord O’Shaughnessy consulted closely with industry and a wide range of stakeholders across the UK clinical trials sector. The government response welcomes all recommendations from the review, in principle, and makes 5 headline commitments backed by £121 million. An implementation update, setting out progress made against these commitments and a comprehensive response to the remaining recommendations, will be published in the autumn.
  22. Content Article
    For decades the NHS has collected routine data on millions of patients. In a world where big data has increasing value, the UK has an opportunity to truly leverage its health data assets to benefit people in the UK and across the world—both through better health and through the generation of more research and development and economic growth. This report by the Institute of Global Health Innovation at Imperial College London provides a broad overview of the UK’s health data policy landscape. It identifies strategic and technical recommendations to move towards a health data policy ecosystem that allows clinical, societal or financial value to be more readily extracted from patient data.
  23. News Article
    Over-50s and younger adults with underlying health conditions are being urged to participate in a study of life-saving treatments for COVID-19. The study is open to those who test positive for Covid and had symptoms develop in the previous five days. Volunteers will be given pills to take at home. The study will help decide how antiviral drugs will be used, Prof Sir Jonathan Van-Tam, the deputy chief medical officer for England, said. Health Secretary Sajid Javid asked everyone eligible to "step forward" and "help us to learn more about medicines which could save thousands of lives". Antivirals were "part of our approach as we learn to live with Covid, by preventing the most vulnerable from being hospitalised", he said. The UK regulator has licensed both for treating Covid, with molnupiravir the first to be given the green light, in November. Both have completed clinical trials and shown promising results at reducing the risk of serious illness or death. Launched in December, it already has 4,500 people signed up but needs 6,000 more as soon as possible. You can sign up at the study website now or your GP may contact you to ask you to participate if you test positive for Covid. Read full story Source: BBC News, 25 January 2022
  24. News Article
    Health experts have expressed fears over the impact tighter Covid restrictions in England could have on cancer patients as alarming new figures reveal that the number taking part in clinical trials plummeted by almost 60% during the pandemic. Almost 40,000 cancer patients in England were “robbed” of the chance to take part in life-saving trials during the first year of the coronavirus crisis, according to a report by the Institute of Cancer Research (ICR), which said COVID-19 had compounded longstanding issues of trial funding, regulation and access. Figures obtained from the National Institute for Health Research by the ICR show that the number of patients recruited on to clinical trials for cancer in England fell to 27,734 in 2020-21, down 59% from an average of 67,057 over the three years previously. The number of patients recruited for trials fell for almost every type of cancer analysed. Health experts said the relentless impact of Covid on the ability of doctors and scientists to run clinical trials was denying many thousands of cancer patients access to the latest treatment options and delaying the development of cutting-edge drugs. Read full story Source: The Guardian, 9 December 2021
  25. News Article
    Researchers have launched a major clinical trial investigating whether people on long-term immune-suppressing medicines can mount a more robust immune response to COVID-19 booster jabs by interrupting their treatment. The VROOM trial will have implications for people on immune-suppressing medicines, who are among the millions of clinically vulnerable patients advised to ‘shield’ during the pandemic. The study is funded by an NIHR and the Medical Research Council (MRC) partnership, and led by a team at the University of Nottingham. Approximately 1.3 million people in the UK are prescribed the immune-suppressing drug methotrexate for inflammatory conditions such as rheumatoid arthritis, and skin conditions such as psoriasis. Many of them were among the 2.2 million clinically extremely vulnerable people advised to shield during the first phase of the pandemic, depending on specialist advice and on their risk factors. While methotrexate is effective at controlling these conditions and has emerged as first line therapy for many illnesses, it reduces the body’s ability to generate robust responses to flu and pneumonia vaccines. Researchers will recruit 560 patients currently taking methotrexate, to investigate whether taking a two week break in this drug immediately after they receive the COVID-19 booster jab improves their immune response to vaccination, while preventing flare-ups of their long-term illness. The study will take between one to two years to complete. All participants will have had the Pfizer-BioNTech vaccine as their third jab, as part of the national vaccination programme against COVID-19. Professor Andy Ustianowski, NIHR Clinical Lead for the COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said: “Although the vaccine rollout has saved many lives and helped drive down the effects of the pandemic, there are still groups of vulnerable people who can’t always mount robust immunity against the virus. " “It’s important to establish if people can safely improve protection from their booster jabs by taking a break from their immune-supressing medicines, and this pivotal study will help develop our understanding of immune responses in people taking this widely prescribed medicine." Read full story Source: NIHR, 12 November 2021
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