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Showing results for tags 'Clinical trial'.
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Community PostHi 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
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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 -
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News ArticleThe 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
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News ArticleLow 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
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Content ArticleRECOVERY was established in March 2020 as a randomised clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone (a corticosteroid). As an urgent public health study, the trial has been prioritised for delivery across the UK by the NIHR. Through the NIHR’s Clinical Research Network, over 11,500 patients have so far been enrolled into RECOVERY from over 175 NHS hospitals in the UK. A total of 2104 patients were randomised to dexamethasone once per day for ten days and were compared with 4321 patients randomised to usual care alone. Among the usual care control group, 28-day mortality was highest in those on ventilators (41%), intermediate in those on oxygen only (25%), and lowest among those who were not receiving any respiratory intervention (13%). The study, conducted at the University of Oxford and led by Professor Peter Horby and Professor Martin Landray, found that dexamethasone reduced the risk of dying by one-third in ventilated patients and by one fifth in other patients receiving oxygen only. There was no benefit among those who did not need respiratory intervention.
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News ArticleA 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
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News Article
Blood transfusion trial begins for COVID-19 patients in UK
Patient Safety Learning posted a news article in News
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 -
News Article
Coronavirus drugs trial to begin at UK homes and GP clinics
Patient Safety Learning posted a news article in News
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 -
News Article
WHO halts hydroxychloroquine trial for coronavirus amid safety fears
Patient Safety Learning posted a news article in News
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 -
News ArticleSouthampton 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
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News Article
Coronavirus: NHS to offer drug that can shorten recovery time by four days
Patient Safety Learning posted a news article in News
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
