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Found 61 results
  1. Content Article
    Cancer Research UK, in partnership with London-based tech company Stitch, are piloting an app for patients to use whilst participating in a clinical trial. The Trialmap app, which was co-created with patients, is being piloted on a clinical trial run by Cancer Research UK’s Centre for Drug Development. The aim of the app is to ensure patients feel valued for their participation, and to improve patient experience during clinical trials. This article looks at how the app: allows patients to easily view information about the trial gives reminders about appointments and what patients might need to do to prepare for them gives patients the opportunity to provide real-time feedback regarding their time on the trial.
  2. News Article
    German public research funder Deutsche Forschungsgemeinschaft (DFG) is conducting an audit of the clinical trials it has supported in the past. The audit was announced in response to a request from TranspariMED asking DFG for a list of all its trials completed between 2009 and 2017, to which DFG replied that it currently has no such comprehensive dataset. DFG stated that it is "currently preparing an evaluation of its clinical trials programme. In the framework of this evaluation the data you requested will be collected and analysed, as the outcomes of trials supported by DFG is of high interest including for DFG itself." TranspariMED, an organisation which aims to end evidence distortion in medicine, sees this development as a good opportunity for DFG to check whether and when clinical trials were registered and their results made public. Previous research has shown that nearly a third of German academic trials never make their results public. This not only wastes public money, but also harms patients because it leaves gaps in the evidence base on the efficacy and safety of drugs, medical devices, and non-drug treatments. Due to gaps in German law, there is still no legal obligation to make the results of many German clinical trials public. Read full story Source: TranspariMed, 20 December 2022
  3. Content Article
    On 31 January 2023, the clinical trial information system (CTIS) will become the single entry point for sponsors and regulators of clinical trials in the European Union (EU). The CTIS includes a public searchable database for healthcare professionals, patients and the public. This webpage contains information on how clinical trials are regulated in the EU, and what changes the CTIS will make to how clinical trials are registered, performed and regulated.
  4. News Article
    With flu cases rising, UK Covid scientists are turning their attention to finding the best life-saving drugs to fight the winter virus. A trial will run across 150 hospitals this year and next, recruiting thousands of patients. Flu vaccines help prevent infection but each year some people become very sick. And antiviral tablets - given within a couple of days of symptoms developing - are designed to reduce the severity of these bad infections. One of the pills the Imperial College London team will be testing is oseltamivir, or Tamiflu. It is recommended to treat severe flu - but whether it saves lives is unclear. Funded by the National Institute for Health and Care Research, the Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia (Remap-Cap) will study how good the treatments are at reducing deaths and intensive care admissions. Chief investigator Prof Anthony Gordon told BBC News: "We want to learn at pace what works, just like we did during Covid. "We'll test multiple treatments in different combinations. Some are antivirals that stop the virus, others are steroids or other treatments that work on how the body responds to infections. "We hope that our trial will help to find urgently needed flu treatments rapidly. Our Covid trial changed clinical practice globally and we hope we can impact flu treatment and reduce winter pressures on the NHS in the same way." Read full story Source: BBC News, 29 November 2022
  5. 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
  6. Content Article
    This paper in the Journal of Patient Safety and Risk Management addresses the issue of untested products being used on the basis of 'equivalent' products having undergone regulatory testing. Manufacturers of competing products often use each other’s evidence, arguing that the published evidence is generally applicable even if the original tests and trials were performed on only one specific product. In this study, the authors looked at prophylactic dressings for pressure injury prevention to demonstrate how patient safety may be compromised if study conclusions are projected onto unstudied products.
  7. Content Article
    Clinical trials are the foundation of modern medicine, but regulators, doctors and patients often do not get to see the full picture about how safe and effective drugs and treatments are. The results of around half of all clinical trials remain hidden and there are international efforts to resolve this issue; even government agencies often lack access to the information they need to decide whether treatments are safe and effective.  The paper analyses six case studies in which lack of transparency in medical research has directly harmed patients, taxpayers and/or investors. It illustrates how these harms could have been avoided through three simple solutions promoted by the AllTrials campaign: trial registration, results posting, and full disclosure of trial reports.
  8. Content Article
    This joint position statement from The Royal College of Physicians (RCP) and National Institute for Health and Care Research (NIHR) sets out a series of recommendations for making research part of everyday practice for all clinicians. Its recommendations are aimed at stakeholders across the health and care system, with the overall aim of embedding research in clinical practice: Trusts, health boards and integrated care systems (ICSs) Health Education England and NHS England and statutory education bodies and the departments of health in the other UK nations Regulators Funders
  9. Content Article
    Each year, up to 100 million people in the US experience acute or chronic pain, mainly because of short-term illnesses, injury and medical procedures. It is therefore important that patients are offered effective treatment options to reduce symptoms and improve function. Nonopioid management is the preferred option, but there are circumstances for which short-term opioid therapy is appropriate and beneficial. Finding the balance between these approaches is an ongoing problem in the management of acute noncancer pain. This cluster randomised clinical trial featured in JAMA Health Forum, aimed to assess whether clinician-targeted interventions prevent unsafe opioid prescribing in ambulatory patients with acute noncancer pain. The authors found that the use of comparison emails decreased the proportion of patients with acute pain who had never taken opioids receiving an opioid prescription. The emails also reduced the number of patients who progressed to treatment with long-term opioid therapy or were exposed to concurrent opioid and benzodiazepine therapy. They concluded that healthcare systems could add clinician-targeted nudges to other initiatives as an efficient, scalable approach to further decrease potentially unsafe opioid prescribing.
  10. Content Article
    In this article, Maryanne Demasi looks at the continued prescription of Makena, an injectable synthetic hormone approved by the US Food and Drug Administration (FDA) to women who are at high-risk of premature delivery. Makena claims to reduce the risk of pre-term birth and was approved in 2011 on an accelerated pathway by the FDA following an initial trial that showed positive outcomes. However, Demasi explains, the study has been discredited as flawed in its methods and findings, and a confirmatory trial conducted by the manufacturer showed that Makena does not actually prevent preterm birth. In spite of this, and in the face of known risks, Makena is still being prescribed to pregnant women as the manufacturer has refused to withdraw it from the market. She highlights the dangers of the FDA not taking stronger action against the manufacturer of Makena, by looking at the example of Diethylstilbestrol (DES), a synthetic hormone use by women from the 1930's to the 1970s to prevent miscarriages and premature births. DES was later found to cause cancers, immune and cardiovascular disorders and other abnormalities in pregnant women, their children and their grandchildren.
  11. Content Article
    The Covid-19 pandemic presented the need for fast decision-making in a rapidly shifting global context. This article in BMJ Evidence Based Medicine looks at the limitations of traditional evidence-based medicine (EBM) approaches when investigating questions in the context of complex, shifting environments. The authors argue that it is time to take a more varied approach to defining what counts as ‘high-quality’ evidence. They introduce some conceptual tools and quality frameworks from various fields involving what is known as mechanistic research, including complexity science, engineering and the social sciences. The article proposes that the tools and frameworks of mechanistic evidence, sometimes known as ‘EBM+’ when combined with traditional EBM, may help develop the interdisciplinary evidence base needed to take us out of this protracted pandemic.
  12. News Article
    The parents of a teenage girl who died from an allergic reaction to a Pret a Manger baguette have set up a clinical trial to make "food allergies history". Nadim and Tanya Ednan-Laperouse's daughter Natasha, 15, died in 2016 after eating a baguette containing sesame, to which she was allergic. The trial will investigate if everyday food products can be used as treatment. It is a unique opportunity to establish immunotherapy as a practical treatment, according to an expert. The trial, set up by the family from Fulham in west London, will see whether commonly available food products, such as milk and peanuts, can be used under medical supervision to treat those with food allergies. After a 12-month desensitisation period, those involved will be tracked for two further years. Mr and Mrs Ednan-Laperouse's daughter died in 2016 after she ate an artichoke, olive and tapenade baguette containing sesame seeds, bought from a Pret a Manger at Heathrow Airport. The wrapper did not have any allergy information, and, as it was made on the premises, this was not required by law at the time. In October, "Natasha's Law" was brought in, making allergy information a requirement for food made on site. Read full story Source: BBC News, 18 May 2022 Related articles on the hub Why allergies are the Cinderella service of the NHS – a blog by Tim McLachlan
  13. Event
    until
    Join the National Academies of Sciences, Engineering, and Medicine’s Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials and Research as it discusses its newly released report Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. This new report makes a compelling case for why we need more equitable participation in clinical trials and clinical research, including an economic analysis on the cost of health disparities in the United States. It provides a review of the barriers to having more equitable participation in clinical trials, describes strategies to overcome those barriers, and provides actionable recommendations to drive lasting change on this issue. The webinar will take place at 11:00-13:00 EST (16:00-18:00 GMT+1) Register for the webinar
  14. 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.
  15. 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
  16. 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
  17. 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.
  18. 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
  19. News Article
    Pfizer’s oral antiviral drug paxlovid significantly reduces hospital admissions and deaths among people with COVID-19 who are at high risk of severe illness, when compared with placebo, the company has reported. The interim analysis of the phase II-III data, outlined in a press release, included 1219 adults who were enrolled by 29 September 2021. It found that, among participants who received treatments within three days of COVID-19 symptoms starting, the risk of covid related hospital admission or death from any cause was 89% lower in the paxlovid group than the placebo group. Commenting on the announcement, England’s health and social care secretary, Sajid Javid, said, “If approved, this could be another significant weapon in our armoury to fight the virus alongside our vaccines and other treatments, including molnupiravir, which the UK was the first country in the world to approve this week.” Read full story Source: BMJ, 8 November 2021
  20. 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.
  21. 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.
  22. 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.
  23. 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
  24. News Article
    Early results from trials of a Covid vaccine developed in Russia suggest it could be 92% effective. The data is based on 20 cases of COVID-19 from 16,000 volunteers given the Sputnik V vaccine or a dummy injection. While some scientists welcomed the news, others said the data had been rushed out too early. It comes after Pfizer and BioNTech said their vaccine could prevent 90% of people getting Covid-19, based on a study of 43,500 people. Although the Sputnik data is based on fewer people being vaccinated and fewer cases of Covid developing during the trial, it does confirm promising results from earlier research. The Sputnik V vaccine, developed at the National Research Centre for Epidemiology and Microbiology in Moscow, is currently going through phase III clinical trials in Belarus, UAE, Venezuela and India. So far there are no safety issues, with Russian researchers saying there were "no unexpected adverse events" 21 days after volunteers received their first of two injections. Read full story Source: BBC News, 11 November 2020
  25. News Article
    Pfizer and BioNTech have said that their coronavirus vaccine may be more than 90% effective, after the two pharmaceutical firms released interim data from their ongoing large-scale trial. Preliminary analysis, conducted by an independent data monitoring board, looked at 94 infections recorded so far in the vaccine’s phase 3 study, which has enrolled nearly 44,000 people in the US and five other countries. Of those participants who were infected with COVID-19, it is currently unclear how many had received the vaccine versus those who had been given a placebo. The current efficacy rate, which is much better than most experts expected, implies that no more than eight volunteers will have been inoculated. The data have yet to be peer-reviewed, and Pfizer said the initial protection rate might change by the time the study ends. The longevity of the immune response provoked by the mRNA-based vaccine also remains unknown. However, the findings are the most promising indication to date that a vaccine will be effective in preventing disease among infected individuals, handing humanity a crucial tool in tackling the pandemic. Pfizer and its German partner BioTech will continue with the phase 3 trial until 164 infections have been reported among volunteers - a figure that will give regulatory authorities a clearer idea of the vaccine’s efficacy. This number is expected to be reached by early December in light of the rising US infection rates, Pfizer said. The two companies said they have so far found no serious safety concerns and expect to seek US emergency use authorisation later this month. Read full story Source: The Independent, 9 November 2020
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