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Found 60 results
  1. Content Article
    Participants are vital to the success of any clinical trial. Without the data they provide, our research system would collapse. But being a clinical trial participant is not easy. Financial barriers, transport challenges, and a lack of engagement and support can leave patients feeling marginalised and disconnected. This article looks at what needs to be done to ensure diverse patients from around the world can engage with studies and remain engaged from screening until study completion, regardless of their personal circumstances.
  2. Content Article
    In this article, published by Med Page Today, clinical trials are the cornerstone of evidence-based medicine authors argue that: "All trial results - positive, negative, and neutral - must be made publicly available to allow for transparent decision-making by patients, physicians, and regulators. Without complete data, the evidence gets distorted: harms are downplayed, and benefits are overstated."
  3. Content Article
    TrialResults.com present the results of completed clinical trials in an easy to understand format. The site allows you to search for clinical trials related to different areas and conditions, and filter results by country and sponsor. You can they view and download a Plain English summary of each trial. It was set up by TrialAssure, a global company committed to clinical trial and human health data transparency for the entire pharmaceutical industry.
  4. News Article
    Women are underrepresented in clinical trials, and even lab mice are predominantly male – and the effects show up in almost every aspect of human health Women are twice as likely as men to die from heart attacks; when a nonsmoker dies of lung cancer, it’s twice as likely to be a woman as a man; and women suffer more than men from Alzheimer’s and autoimmune disease. Yet research into these conditions, and many more, generally fails to examine women separately. It’s even less likely to look at disparities affecting women of color – why, for instance, Black women are nearly three times more likely to die in pregnancy than white women are. It’s been 30 years since the US Congress ordered the National Institutes of Health to make sure women were included equally in clinical trials. Despite some progress, research on women still lags, and there’s growing evidence that women and girls are paying the price. “Research on women’s health has been underfunded for decades, and many conditions that mostly or only affect women, or affect women differently, have received little to no attention,” the first lady Jill Biden said in announcing a new White House initiative on women’s health research on 13 November. “Because of these gaps, we know far too little about how to manage and treat conditions like endometriosis, and autoimmune diseases like rheumatoid arthritis. These gaps are even greater for communities that have historically been excluded from research – including women of color and women with disabilities.” Not only do researchers fail to include enough women in clinical trials, they often don’t look for differences between how men and women respond to treatments. Read full story Source: The Guardian, 20 November 2023 Further reading on the hub Dangerous exclusions: The risk to patient safety of sex and gender bias Gender bias: A threat to women’s health Animal testing doesn't work, we need to find new ways of testing the safety of medicines—a blog by Pandora Pound
  5. News Article
    A new report by US healthcare communications agency GCI Health found that Black women aren't avoiding clinical trials due to mistrust. The reasons for their underrepresentation are “more layered and nuanced.” The report is based on a recent summer survey with 500 responses from Black women across the USA. It reveals that, while the majority (80%) are "open" to participating in a clinical trial, 73% have never been asked to do so. While it's commonly believed that Black women are unwilling to participate in trials due to mistrust of the healthcare and biopharma systems, GCI's survey responses unveiled a more complex perspective. The data suggest “that access to information is the largest barrier to participation, rather than mistrust in the medical establishment, as commonly believed,” GCI Health’s report found. “We often hear that Black women are missing from clinical research because they are ‘hard-to-reach’ or reluctant to participate due to mistrust of the medical establishment,” said Kianta Key, group senior vice president and head of identity experience at GCI Health, in a press release. “In talking with women, we heard something more layered and nuanced that deserved exploration.” “Our industry has a responsibility to reverse years of underrepresentation in clinical trials and do more to support better healthcare outcomes for Black women,” said Kristin Cahill, global CEO of GCI Group, in the release. “Equity is critical to ensure new treatments and health interventions work for everyone. This research helps get us closer to understanding what needs to be done to make positive changes that will save lives and create healthier communities.” Read full story Source: Fierce Pharma, 14 November 2023
  6. Content Article
    In this blog, Pandora Pound, Research Director at Safer Medicines Trust, highlights the patient safety issues that come when we rely on animal testing to determine the safety of new drugs for use in humans. She looks at cases where animal testing has led to the belief that medications were safe to test in human clinical trials—with sometimes tragic results. Highlighting innovative technologies that offer a more accurate picture of the safety of medications in humans, she calls on policy makers to lead a move towards human biology-based approaches.
  7. Content Article
    Clinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This study characterises the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the review of oncology trial documents for clinical trial implementation by centralized clinical content specialists. The study demonstrates a gap in patient safety when assessing trial documents for clinical trial implementation. One solution to address this gap is the utilisation of a centralised team of clinical specialists to preemptively review trial documents, thereby enhancing patient safety during clinical trial conduct.
  8. News Article
    An NHS body is encouraging women with breast cancer from minority backgrounds to take part in more clinical trials, after research found they are under-represented in studies that can offer life-saving treatment. The pilot project, supported by the NHS Race and Health Observatory, is intended to improve representation in breast cancer clinical trials partly through culturally sensitive communications to people from racially diverse backgrounds. Research from the UK Health Security Agency suggests young black women are more likely to have aggressive breast cancer tumours, experience poorer care and have higher mortality rates, but are significantly under-represented in clinical research. Their lack of inclusion in trials could be partly down to distrust of the research process and a lack of knowledge, according to research by the UK’s National Institute for Health Research. The project, which works in conjunction with Macmillan Cancer Support and the pharmaceutical company Roche, will run for a year and look at developing new ways for people with breast cancer to access clinical trials. It will develop action plans to improve representation and provide enhanced support for patients. Read full story Source: The Guardian, 31 August 2023
  9. 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.
  10. 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
  11. News Article
    A vaccine that promises to protect infants and the over-75s from a lung infection which adds to pressure on the NHS each winter has been backed by government advisers. Respiratory syncytial virus (RSV) is a leading cause of pneumonia in the very young and elderly. It typically causes between 22,000 and 30,000 hospital admissions of small children a year. RSV’s impact on the elderly is less well understood but important, and experts believe that an effective vaccine could significantly lessen winter pressures on the health service. After 60 years of research, vaccines for older adults from Britain’s GSK and its US rivals Pfizer and Moderna are in the final stages of development. The Joint Committee on Vaccination and Immunisation (JCVI) believes that they could be licensed this year or early next year and trial data suggest that they work well. Read full story (paywalled) Source: The Times, 23 June 2023
  12. News Article
    Elon Musk's attempt to implant microchips into human brains has been rejected by US medical regulators over concerns about the safety of the technology. Mr Musk's Neuralink business, which is hoping to insert tiny chips into people's skulls to treat conditions such as paralysis and blindness, was denied initial permission for clinical trials last year. US medical regulators were said to have "dozens" of concerns over the risks posed by the device, Reuters reported. Concerns include fears that tiny electrodes could get lodged in other parts of the brain, which could impair cognitive function or rupture blood vessels. Neuralink's chips are designed to be threaded into the brain using tiny filaments and harness artificial intelligence technology to pick up brain activity using a so-called "brain computer interface". Read full story (paywalled) Source: The Times, 3 March 2023
  13. News Article
    The state of clinical trials in the NHS is “much worse than it has been in years” with patients losing access to cutting-edge cancer and dementia treatments, one of the UK’s most senior clinicians has warned. Sir John Bell, the regius professor of medicine at the University of Oxford and a government life sciences adviser, said the UK’s approach needed “a full overhaul, top to bottom” to prevent a collapse in the number of clinical trials being conducted in the NHS. “I don’t think there’s any doubt that companies are choosing not to evaluate their drugs in the UK,” he said. “The risks [to patients] are much bigger than have been alluded to.” The intervention comes after the government launched an independent review led by the former health minister James O’Shaughnessy into why the NHS had seen a 44% drop in participants recruited to commercial clinical trials in the past five years. The UK is rapidly losing ground to countries such as Spain, Poland and Australia, falling from fourth to 10th internationally for phase III trials. Reduced access to trials is particularly concerning for patients with limited routine treatment options, such as the roughly 3.5 million people living with rare diseases and patients with dementia and advanced cancer. Read full story Source: The Guardian, 27 February 2023
  14. 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
  15. News Article
    A blood test which can detect 50 cancers before symptoms start to show could be offered to a million people in a pilot programme from next summer, according to the head of the NHS. Amanda Pritchard, NHS chief executive, said the Galleri test has the potential to “transform cancer care forever”, according to reports. The liquid biopsy detects tiny fragments of tumour DNA in the bloodstream and alerts doctors as to whether a cancer signal has been detected and predicts where in the body that signal may have originated. If early results are successful, a pilot screening programme involving one million patients over two years is scheduled to begin next summer. The test is expected to find 5,000 potential cases of the disease every year. Read full story Source: The Guardian, 15 June 2023
  16. News Article
    Lord O’Shaughnessy has carried out a widespread review of clinical trials in Britain and found it is falling behind in medical research. He has suggested a raft of reforms, which include financial incentives for GPs who carry out community drugs and treatments trials on their patients at local surgeries or in their own homes. Patients who receive genomic testing on the NHS should also be automatically asked to consent to their genetic data being used for research, the report recommends. The Medicines and Healthcare products Regulatory Agency (MHRA) has been told to cut red tape and speed up approvals for medicines. It has also been asked to approve clinical trials within 60 days of submission. Writing in The Telegraph, Will Quince, Minister of State for Health and Secondary Care, said: “Cutting the time it takes for new medicines to reach patients is vital and has a direct impact on how patients recover faster or better manage conditions. “We want to make it easier for more people to be a part of life-changing research and giving the option to take part in trials virtually will improve the scope of who wants to, or can take part. “From cancer to obesity, these research studies can lead to billions of pounds in savings for the NHS and cut waiting lists through faster diagnosis and enhanced treatment.” Read full story (paywalled_ Source: The Telegraph, 26 May 2023
  17. News Article
    A proposed exercise trial for Long Covid is being criticised by some of the patients the government-funded researchers want to study. The trial is part of the Researching COVID to Enhance Recovery (RECOVER) initiative, funded by the US government for $1.15 billion over four years. It aims to study Long Covid and help find treatments for the millions of people experiencing a range of long-lasting symptoms, including extreme fatigue, brain fog and shortness of breath. The exercise study protocol has not been finalised, but it will test physical therapy at different intensity levels, tailored to the patient’s capabilities, and aim to improve endurance, said Adrian Hernandez, executive director of Duke Clinical Research Institute. Some Long Covid advocates, however, say that any exercise trial could be potentially dangerous for long-covid patients with myalgic encephalomyelitis (ME/CFS), also known as chronic fatigue syndrome. Studies show that people with ME/CFS don’t have the same response to physical exertion as healthy individuals, and many ME/CFS patients report a worsening of symptoms after even small amounts of activity. This crash is called post-exertional malaise. Advocates now worry that Long Covid patients with ME/CFS could be similarly harmed if they take part in any exercise study. Read full story (paywalled) Source: Washington Post, 22 May 2023 Further reading on the hub: Understanding Covid-19 as a vascular disease and its implications for exercise
  18. News Article
    Investors are pouring billions into companies claiming they can analyse DNA to find the disease early. But some scientists question if they really work. A pioneering group of people in the US and UK who have elected to take part in a new form of cancer screening known as multi-cancer early detection tests (MCED). The tests use gene sequencing or other novel technologies to detect fragments of DNA expelled by cancerous cells which circulate in people’s blood, allowing the identification of multiple types of cancer from a single blood draw. They have been hailed as “revolutionary” and “cutting edge” by British and US health chiefs. Health bodies in both nations have set up MCED clinical trials in the hope that the tests can be rolled out to the population at large. The UK’s NHS is participating in a clinical trial of the Galleri test involving 140,000 patients. But not everyone is convinced the tests live up to the hype. Several health experts and scientists told the Financial Times that the tests could harm rather than help some patients due to risks associated with misdiagnosis, over-diagnosis and over-treatment. Read full story (paywalled) Source: The Financial Times, 17 May 2023
  19. News Article
    The world is “on the cusp of a first generation of treatments for Alzheimer’s disease”, experts have said, as a new drug was found to slow cognitive and functional decline. The drug donanemab, made by Eli Lilly and Company, slowed decline by 35% to 36% in a late-stage phase 3 clinical trial, the company said. Donanemab appeared to slow the decline associated with Alzheimer’s compared to placebo in 1,182 people with early-stage disease based on those with intermediate levels of a protein known as tau. The drug also resulted in 40% less decline in the ability to perform activities of daily living, according to the firm. Dr Susan Kolhaas, executive director of research and partnerships at Alzheimer’s Research UK, said: “This is incredibly encouraging, and another hugely significant moment for dementia research". “The treatment effect is modest, as is the case for many first-generation drugs, and there are risks of serious side effects that need to be fully scrutinised before donanemab can be marketed and used. “However, this news underlines the urgency of preparing the NHS to make these treatments available should regulators deem them safe and effective". Read full story Source: The Independent, 3 May 2023
  20. 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.
  21. 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.
  22. 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.
  23. Content Article
    This article by Till Bruckner of Transparimed outlines how a new UK law will affect how clinical trial results are reported. The UK Government will introduce a legal requirement to make the results of all clinical trials public within 12 months of trial completion. Any company or university breaking the law will be refused permission to start new trials.
  24. Content Article
    This article in BBC Science Focus looks at the factors driving an increase in testosterone prescribing for women in the UK. The author, Dr Michelle Griffin, highlights the need to ensure that there is a strong evidence base for prescribing testosterone to women. While there have been some clinical trials and studies around testosterone as a treatment for low libido, there is concern that patients, doctors and pharma companies are relying on anecdotal accounts of its effectiveness to treat symptoms such as low mood, poor concentration and tiredness. She also highlights that testosterone prescribing is just one example of the lack of research going into women's health issues and treatments, and argues that this is contributing to health inequity.
  25. 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
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