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Found 83 results
  1. News Article
    The government is aiming for a significant expansion of clinical trials in the UK, and plans to use the NHS app to encourage millions of people in England to take part in the search for new treatments. Patients will eventually be automatically matched with studies based on their health data and interests, via the app. The plans envisage alerting them to the trials using smartphone notifications. NHS trusts that fail to meet targets on trials will also be publicly named, and the best performers will be prioritised for funding, as part of improvements designed to restore Britain’s global reputation for medical research. The strategy is one of the first to emerge from the government’s forthcoming 10-year health plan for England. It aims to take advantage of changes simplifying NHS records by quickly identifying people suitable for a trial. It will also include measures to streamline the paperwork required for the studies. It is hoped the reforms will speed up the trials process and attract more pharmaceutical companies to host them in Britain, as ministers in all departments are ordered to find pro-growth measures. The 10-year health plan will promise to slash set-up times for trials. While it takes about 100 days to set up a trial in Spain, it now takes 250 days in the NHS. The plan will push for commercial clinical trial set-up times to fall to a maximum of 150 days by March 2026. Read full story Source: The Guardian, 16 June 2025
  2. News Article
    As the Trump administration contemplates new clinical trials for Covid boosters and moves to restrict Covid vaccines for children and others, parents whose children participated in the clinical trials expressed anger and dismay. “It’s really devastating to see this evidence base officially ignored and discarded,” said Sophia Bessias, a parent in North Carolina whose two- and four-year-old kids were part of the Pfizer paediatric vaccine trial. “As a parent and also a paediatrician, I think it’s devastating that we might no longer have the option to protect kids against Covid,” said Katherine Matthias, a paediatrician in South Carolina and a cofounder of Protect Their Future, a children’s health organization. Robert F Kennedy Jr, head of the US Department of Health and Human Services (HHS), has called for new trials using saline placebos for each of the routine childhood vaccines recommended by the Centers of Disease Control and Prevention (CDC), even though these vaccines have already been tested against placebos or against vaccines that were themselves tested against placebos. Marty Makary, the head of the US Food and Drug Administration (FDA), and Vinay Prasad, the FDA’s vaccines chief, outlined a plan in a recent editorial to restrict Covid boosters for anyone under the age of 65 without certain health conditions. For everyone else between the ages of six months and 64 years old, each updated Covid vaccine would need to undergo another randomized controlled clinical trial, Makary and Prasad said. It’s not clear when, how or whether this plan will be implemented officially. On Tuesday, top US health officials said on the social media site X that they would remove the recommendation for Covid vaccination from the childhood immunization schedule, and would also cease recommending it for pregnant people, who have much higher risks of illness, death and pregnancy complications with Covid. On Friday, the CDC appeared to contradict that announcement by keeping Covid vaccines as a routine immunization for children – though the agency now says health providers “may” recommend the vaccine, instead of saying they “should” recommend it. Changing recommendations could affect doctors’ and parents’ understanding of the safety and effectiveness of the vaccines. Read full story Source: The Guardian, 2 June 2025
  3. News Article
    Health experts are calling for more UK clinical trials to focus on finding new treatments for women, as “concerning” data reveals they are severely under-represented, with 67% more male-only studies than female-only. Details of thousands of studies were collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and the University of Liverpool. The evidence shows the UK is a hub for pioneering research, with one in eight trials testing humans for the first time, and cutting-edge treatments such as gene therapies becoming a new growth area. But a review of the data by the Guardian found that women were significantly under-represented. Both sexes were included in most trials (90%), but male-only trials (6.1%) were nearly twice as common as female-only studies (3.7%). Pregnant and breastfeeding women were especially under-represented – involved in just 1.1% and 0.6% of trials respectively. Women’s health experts expressed alarm over the figures, which they said meant women and their doctors were having to make decisions about whether to take a drug in a “vacuum of evidence”. Some areas of research are dominated by men at all levels – funders, researchers, consultants and patients – and as a result there could be a “reluctance” to fund female-only trials, the experts added. Dr Amy Brenner, an assistant professor in the clinical trials unit at the London School of Hygiene & Tropical Medicine (LSHTM), said: “It is particularly concerning that there are more male-only trials than female-only trials as, while they may be disease-specific, it is certainly not true that there are more male-only than female-only diseases.” The gender gap had serious implications, Brenner said. “This under-representation means there is a lack of evidence on the safety and effectiveness of many interventions in women.” There was an “urgent need” to correct the disparity in order to improve women’s health outcomes, she added. Read full story Source: The Guardian, 7 May 2025 Further reading on the hub: Medicines, research and female hormones: a dangerous knowledge gap
  4. Content Article
    It’s nearly 30 years since the Food and Drug Administration (FDA) Modernization Act of 1997, when Congress instructed the US Health and Human Services (HHS) secretary to consult with the National Institutes of Health (NIH) director and the pharmaceutical industry to “review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials." In this JAMA article, Rita Rubin examines concerns that the Trump administration’s dismantling of diversity, equity, and inclusion (DEI) efforts at the FDA and NIH will result in a reversion back to the days when new treatments were tested mainly in cisgender White men—and not even all shapes and sizes of them.
  5. News Article
    Attorney generals from 22 states filed a lawsuit against the Trump administration on Monday over significant cuts to grant funding for universities, medical centers, and other research institutions last week. The cuts would be “devastating” to staff members and faculty — and could even “prove deadly,” the 59-page lawsuit claimed. The new cap takes effect on Monday. “The reduction of federal funding to the UCs as set forth in the NIH Notice would be devastating for the UC system,” the states noted. The University of California School system is the world's leading public research university system and the state’s third largest employer. “UW has long relied on being able to negotiate these rates for years, and has built out its research facilities and headcount accordingly — nothing could have prepared UW for a sudden and stinging rebuke of the federal government’s previous positions,” they said of the University of Washington. “The impacts would be devastating not only to the many staff members and faculty who would likely lose their livelihood, but could also prove deadly.” “A cut this size is nothing short of catastrophic for countless Americans who depend on UC’s scientific advances to save lives and improve healthcare,” UC President Michael Drake said. “The discovery of new treatments would slow, opportunities to train the next generation of scientific leaders would shrink, and our nation’s science and engineering prowess would be severely compromised,” Harvard University President Alan Garber wrote. Read full story Source: The Independent, 10 February 2025
  6. News Article
    The stop-work order on USAID-funded research has left thousands of people with experimental drugs and devices in their bodies, with no access to monitoring or care. Zsanda Zondi received a startling phone call last Thursday, with orders to make her way to a health clinic in Vulindlela, South Africa, where she was participating in a research study that was testing a new device to prevent pregnancy and HIV infection. The trial was shutting down, a nurse told her. The device, a silicone ring inserted into her vagina, needed to be removed right away. The US Agency for International Development, which funded the study, has withdrawn financial support and has issued a stop-work order to all organisations around the globe that receive its money. The abrupt move followed an executive order by President Trump freezing all foreign aid for at least 90 days. Since then, the Trump administration has taken steps to dismantle the agency entirely. Ms. Zondi’s trial is one of dozens that have been abruptly frozen, leaving people around the world with experimental drugs and medical products in their bodies, cut off from the researchers who were monitoring them, and generating waves of suspicion and fear. In interviews, scientists — who are forbidden by the terms of the stop-work order to speak with the news media — described agonizing choices: violate the stop-work orders and continue to care for trial volunteers, or leave them alone to face potential side effects and harm. In England, about 100 people have been inoculated with an experimental malaria vaccine in two clinical trials. Now, they no longer have access to the clinical trial staff if that vaccine were to cause an adverse reaction in their bodies. Had the trial not been frozen, the participants would be coming to a clinic routinely to be monitored for adverse physical effects, and to have blood and cell samples taken to see whether the vaccine was working. The participants are meant to be followed for two years to assess the vaccine’s safety. An anonymous scientist who worked on the trial said: “It’s unethical to test anything in humans without taking it to the full completion of studies. You put them at risk for no good reason.” Read full story (paywalled) Source: New York Times, 6 February 2025
  7. Content Article
    The EDI Framework is a consensus-based guide developed by the Equality, Diversity, and Inclusion (EDI) Lead and working group of the NIHR’s Clinical Research Network North West London. This work involved analysing challenges to integrating EDI within the clinical research process, for example, in clinical trial protocols as directed by industry sponsors and NHS investigator teams. The framework is targeted at clinical research teams, industry sponsors, and academic investigators. The framework recognises that the lack of diverse clinical research populations fuels health inequalities in the UK and the need to reverse this. It aims to embed equity, diversity, and inclusion processes within clinical trials and health and social care research. Key objectives include: To provide a practical framework for positive action integrating EDI into clinical research design, protocols, and implementation. Establish accountable clinical research systems that are trustworthy to the public and accessible to diverse communities. It advises an interconnected approach to embedding EDI throughout the entire clinical research lifecycle. By following this framework, the EDI working group aspires to guide clinical research towards a more equitable, inclusive, and representative model that better serves the needs of all populations. It highlights the opportunity benefit of embedding EDI processes within clinical research and health care innovation. Integrating EDI is presented as a critical commitment for commercial sponsors and academics beyond profit or reputation.
  8. Content Article
    This study looked at attitudes towards, and perceptions of, participating in clinical trials among patients with cancer and their relatives. It explored what factors are associated with their willingness or hesitation to engage. The researchers carried out a survey of 978 patients with cancer and their relatives in Turkey. They found that willingness to participate and knowledge about clinical trials were limited and highlight the existence of significant gaps in understanding and persistent concerns about participation.
  9. News Article
    Wes Streeting has been accused of causing “distress and uncertainty to trans people” and failing to provide clear information on the puberty blockers trial, which is understood to be starting soon. Puberty blockers were banned indefinitely in the UK for under-18s in December after the Cass Review found there was insufficient evidence to show they were safe. It recommended a clinical trial to determine the effectiveness and safety of the medication. It is understood the Department for Health and Social Care (DHSC) expects the trial to begin within the next few weeks and conclude in 2028. But NHS sources told The Independent they are not expecting to publish any details about the trial until February – just one month before it is set to begin – leaving young people wanting to access the medication guessing if they will be part of the trial. Trans charities and campaign groups have so far received little to no information on who will be able to participate in the trial, how they will access it and when it will start, with Stonewall urging the government to “provide certainty to an extremely vulnerable group”. Meanwhile, Tammy Hymas, head of communications and advocacy at charity Mermaids, told The Independent the “severe delays and complete absence of details” on the clinical trial has “left trans youth feeling abandoned”. Read full story Source: The Independent, 26 January 2025
  10. News Article
    A new study by researchers from the Brown University School of Public Health found that pregnant women are regularly excluded from clinical drug trials that test for safety, raising concerns for the efficacy of these medications for maternal and child health. The study, published in the American Journal of Obstetrics and Gynecology, analyzed 90,860 drug trials involving women ages 18 to 45 from the past 15 years and found that only 0.8% included pregnant participants. About 75% of the studies excluded them, potentially leaving critical safety and efficacy questions unanswered. “When pregnant women are excluded from drug trials, it is harder to know if the medication is safe for mothers and their children,” said Alyssa Bilinski, an assistant professor of health services, policy and practice and of biostatistics at Brown’s School of Public Health. “In practice, this means that some people might decide to take medications even absent rigorous evidence, which could lead to harmful side effects. At the same time, others might avoid medications that could actually help them because there’s not enough data to give them confidence about safety.” Read full story Source: Brown University School of Public Health, 17 January 2025
  11. Content Article
    This guidance from the World Health Organization (WHO) updates and adapts the previous work of WHO on research capacity for well-designed and well-implemented clinical trials as framed in resolution WHA75.8 (2022). It aims to enhance clinical research efficiency, minimise research waste and provide guidance on sustained clinical trials that are always functional and active for endemic conditions and can pivot in time of emergency or pandemics.
  12. Content Article
    Racial and ethnic disparities in thyroid cancer care may be reduced by improving enrolment of more diverse patient populations in clinical trials. This study in the journal Surgery looked at trial eligibility criteria and enrolment to assess barriers to equitable representation. The authors found that over the last 3 decades: 1 in 13 thyroid cancer–related clinical trials excluded patients based on language. In the fraction of published studies to report on racial and ethnic demographics, Asian/Native Hawaiian, Black and Hispanic patients were under-represented. They concluded that improving the reporting of demographics in published studies and eliminating exclusion criteria such as language could improve equitable representation of patients in thyroid cancer clinical trials.
  13. Content Article
    The laws which regulate the way clinical trials are carried out in the UK are changing. The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been working for the past two years to draft proposals to update clinical trials regulations. The updated regulations will be debated in the new year and after a 12 month implementation period will come into force in early 2026. Updating this law started in 2022 with a public consultation which asked for feedback on how the regulation of clinical trials could be improved and strengthened in the UK. The statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 was laid before Parliament on 12 December 2024. This article explains the changes to the regulations which aim to create a faster, more efficient, more accessible and more innovative clinical research system in the UK.
  14. Content Article
    Guidelines for blood pressure (BP) measurement recommend arm support on a desk with the midcuff positioned at heart level. Still, nonstandard positions are used in clinical practice (eg, with arm resting on the lap or unsupported on the side). This study looked at the effect of commonly used arm positions on blood pressure (BP) measurements compared to the standard, recommended position. It found that commonly used, nonstandard arm positions during BP measurements substantially overestimate BP, highlighting the need for standardised positioning.
  15. 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.
  16. 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.
  17. 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. A disaster unfolds It’s 2016 and in Rennes, North West France, six healthy male volunteers are taking part in the trial of a drug intended to treat a range of conditions including anxiety, chronic pain and neurodegenerative disorders such as Parkinson’s disease. So far, BIA 10-2474 has been tested in mice, rats, dogs and monkeys, and has been tolerated in humans at doses of up to 20mg. This trial is to assess its safety in humans at a daily dose of 50mg. However, after five days on this dose one man becomes ill and is hospitalised with symptoms similar to a stroke. On the sixth day, four of the five other men are hospitalised with similar symptoms, including headache, memory impairment and altered consciousness. Less than a week later, the first man to become ill lapses into a coma and dies. The remaining five survive, but two are left with residual neurological impairments.[1] A year later, Dr Annelot van Esbroeck and colleagues test the drug on human cells. They discover that the drug deactivates multiple proteins, causing disruption to the metabolism of human nerve cells, effects that could not have been identified in tests on animals.[2] Had such human biology-based tests been conducted prior to the first human trials of BIA 10-2474, disaster may well have been averted. The Rennes disaster came only 10 years after the infamous ‘Elephant Man’ clinical trial at Northwick Park, London, which saw six young men go into multiple organ failure minutes after receiving experimental drug TGN1412. This drug had also undergone extensive tests in animals which had raised no cause for concern.[3] So why do we continue to rely on animal tests? Faulty reasoning New drugs are tested on animals prior to human trials to study toxicity and to gain an idea of how the drug behaves in a whole living organism. The trouble is, while this may provide valuable information on how a drug behaves in a mouse, rat, dog or monkey, it gives only limited information on how that drug will behave in a human. The insights may translate to humans, or they may not. The differences between species make this translational process inherently unreliable and risky. If a drug is found to be toxic in animals, then it won’t proceed to human trials. Conversely, if it is found to be safe in animals it will likely proceed to tests in humans. Unfortunately, as the above disasters illustrate, just because a drug is safe in animals does not mean it will go on to be safe in humans. The only time we know how it will behave in humans is when the first human takes it. As I explain in my book ‘Rat Trap: The capture of medicine by animal research–and how to break free’,[4] volunteers and patients receiving experimental drugs frequently suffer serious and sometimes fatal reactions to experimental drugs. In the field of stroke, for example, the experimental drugs diaspirin, enlimomab, selfotel and tirilazad all improved outcomes in animals, but each led to a greater number of serious adverse events and deaths in stroke patients who took the drugs, compared with those in control groups. But even drugs that proceed successfully through the various stages of testing and go on to be approved and licensed can cause adverse reactions and deaths when used in the wider population. Troglitazone, for example, was approved in 1997 in the US for the treatment of diabetes but had to be withdrawn in 2000 after reports of deaths and severe liver failure. Animal studies had not identified any cause for concern, but a study conducted after the disaster found that tests on human cells and tissues showed strong indications that the drug would adversely affect the liver.[5] I’m not just selecting a few failures from a sea of successes here. An analysis of animal and human toxicity data for over 2,000 drugs found that while the presence of toxicity in animals correlates (although not very reliably) with the presence of toxicity in humans, an absence of toxicity in animal tests is unable to reliably predict an absence of toxicity in humans.[6] So as we’ve seen, if a drug appears safe in animals it can nevertheless go on to be toxic in humans. In other words, animal tests are failing to safeguard humans. Human biology-based approaches Organ chips are tiny, about the size of a computer memory stick. They contain microscopic channels which can be lined with living human cells taken from an organ, through which blood, air and nutrients can be pumped. They are intended to recreate the microenvironment that cells are exposed to within the human body – a home from home for cells. In 2022, Dr Lorna Ewart and colleagues reported an amazing study. They used 870 liver chips to test 27 drugs that, based on evidence from animal studies had been judged safe for human use, but which had gone on to cause serious adverse reactions in humans, including liver failure and death. The liver chips were able to detect toxicity in almost 7 out of every 8 drugs that were toxic to the human liver, far outperforming tests in animals.[7] And it’s not just organ chips that are revolutionising drug development. Computer modelling and AI are playing a significant part too. In the US, software known as DILIsym© has been developed to predict whether new drugs will cause liver injury. It predicted that two migraine drugs would be toxic to the human liver, leading to their development being terminated (despite animal studies failing to raise any significant safety concerns) and it predicted that a related drug would be safe, a finding subsequently confirmed in human trials and resulting in its approval by the FDA.[8],[9] The way forward Animal research and testing is not just an ethical issue for animals, but for humans too. For all our sakes we need to put pressure on our politicians to recognise this and lead a transition away from a reliance on animal testing and towards the more sophisticated, human biology-based approaches which have so much potential to keep us safe. References 1. Kerbrat A, Ferré J-C, Fillatre P, et al. Acute Neurologic Disorder from an Inhibitor of Fatty Acid Amide Hydrolase. N Engl J Med. 2016;375(18):1717-1725 2. van Esbroeck ACM, Janssen APA, Cognetta AB, et al. Activity-based protein profiling reveals off-target proteins of the FAAH inhibitor BIA 10-2474. Science (80- ). 2017;356(6342):1084-1087 3. Attarwala H. TGN1412: From Discovery to Disaster. J Young Pharm. 2010;2(3):332-336 4. Pound P. Rat Trap: The Capture of Medicine by Animal Research - and How to Break Free. Troubador Publishing; 2023. 5. Dirven H, Vist GE, Bandhakavi S, et al. Performance of preclinical models in predicting drug-induced liver injury in humans: a systematic review. Sci Rep. 2021;11(1):6403 6. Bailey J, Thew M, Balls M. An analysis of the use of animal models in predicting human toxicology and drug safety. ATLA Altern to Lab Anim. 2014;42(3):181-199 7. Ewart L, Apostolou A, Briggs SA, et al. Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology. Commun Med. 2022;2(154):1-16 8. Watkins PB. DILIsym: Quantitative systems toxicology impacting drug development. Curr Opin Toxicol. 2020;23-24:67-73 9. Smith B, Rowe J, Watkins PB, et al. Mechanistic Investigations Support Liver Safety of Ubrogepant. Toxicol Sci. 2020;177(1):84-93
  18. 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.
  19. 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
  20. 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
  21. 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
  22. 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.
  23. 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.
  24. 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.
  25. News Article
    The true scale of the number of medical trials using infected blood products on children in the 1970s and 80s has been revealed by documents seen by BBC News. They reveal a secret world of unsafe clinical testing involving children in the UK, as doctors placed research goals ahead of patients' needs. They continued for more than 15 years, involved hundreds of people, and infected most with hepatitis C and HIV. The trials involved children with blood clotting disorders, when families had often not consented to them taking part. The majority of the children who enrolled are now dead. Documents also show that doctors in haemophilia centres across the country used blood products, even though they were widely known as likely to be contaminated. Luke O'Shea-Phillips, 42, has mild haemophilia - a blood clotting disorder that means he bruises and bleeds more easily than most. He caught the potentially lethal viral infection hepatitis C while being treated at the Middlesex Hospital, in central London, which was administered because of a small cut to his mouth, aged three, in 1985. Documents seen by the BBC suggest he was deliberately given the blood product - which his doctor knew might have been infected - so he could be enrolled in a clinical trial. Read full story Source: BBC News, 18 April 2024
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