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Showing results for tags 'Clinical trial'.
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News ArticlePfizer’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
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News Article
Russian Covid vaccine shows encouraging results
Patient Safety Learning posted a news article in News
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 -
News Article
Pfizer coronavirus vaccine is 90% effective, early data suggest
Patient Safety Learning posted a news article in News
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 -
EventuntilJoin 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
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Content ArticleEach 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.
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Content ArticleIn 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.
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Content ArticleThe 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.
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Content ArticleClinical 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.
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Content ArticleThis 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
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Content ArticleThe NIHR-funded and supported study RECOVERY (Randomised Evaluation of COVid-19 thERapY) has announced that the steroid dexamethasone has been identified as the first drug to improve survival rates in certain coronavirus patients.
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Content ArticleProfessor Anne-Sophie Darlington speaks to ecancer at the 2019 EORTC Groups Annual Meeting (EGAM) about the importance of including the patient's experiences and voice during clinical trial assessments. Professor Darlington details the use of questionnaires to measure these patient parameters and how these must be carefully developed to allow flexibility to withstand the evolving environment of clinical trial research.
