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Found 43 results
  1. 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
  2. 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
  3. Event
    The Health Research Authority (HRA) rounds off Make it Public Week with a panel discussion, chaired by Professor Sir Terence Stephenson, HRA Chair. Sir Terence will be joined by a panel representing different parts of the research sector, who will revisit and reflect on the key topics of discussion during the week. We will also be looking forward and at what we – as individuals, organisations, and the sector as a whole – can do next to make research transparent from start to finish, and how we can keep the conversation around research transparency going. Participants can submit questions to the panel ahead of the meeting or live on the day using Slido. You can submit a question in advance when registering for the event. Book now to reserve your free space
  4. Event
    The Health Research Authority is holding its first research transparency week. The effectiveness and relevance of research is improved when opportunities to be involved in research are made more visible, open and accessible to the public. This is because it gives a study the best chance to involve the full range of people who will benefit from the outcomes of research. By having research opportunities more publicly available, researchers will be able to recruit and retain a wide, diverse range of research participants. As a result of increased diversity and better opportunities to access diversity and better opportunities to access research for more people, research will be more relevant, effective, trusted and transparent. At the same time, health professionals, commissioners, researchers, policy makers and funders can use research findings to make informed decisions, which will enhance public trust in research evidence and enhance public accountability. It is equally important to have an awareness and understanding of potential barriers that may restrict members of the public getting involved in research. Identifying these challenges and putting measures in place to counter them is therefore essential in the delivery of transparent research. This will be a two-hour online workshop, chaired by the co-Chairs of the Make it Public campaign group, Matt Westmore, Chief Executive of the HRA, and Derek Stewart, public contributor. The objective for attendees of this workshop will be to work together in facilitated small groups to explore this theme, and produce a set of 'top tips' to support best practice for those active in research. There will also be a short panel discussion, where attendees can hear directly from the study leads and research participants of studies, as well as organisations, working creatively and progressively in this area. NIHR Be Part of Research Patient Research Ambassador scheme, Maidstone and Tunbridge Wells NHS Trust Register for the workshop
  5. Event
    The Health Research Authority is holding its first research transparency week. This workshop will look at the importance of publishing summary results of trials We believe that publishing summary results and data – not just of trials, but of all research – in an open, accessible and public way is a key factor in ensuring research is transparent. Publishing results in a peer-reviewed journal is not always achievable, and findings published in this way may not be accessible to the public. Making the results of research studies public and as easy to access as possible helps builds trust and accountability, whilst ensuring participants are protected from unnecessary studies. It is also a process that helps ensure research funding is maximised by avoiding duplication. This will be a two-hour online workshop, chaired by the co-Chairs of the Make it Public campaign group, Matt Westmore, Chief Executive of the HRA, and Derek Stewart, public contributor. The objective for attendees of this workshop will be to work together in facilitated small groups to explore this theme, and produce a set of 'top tips' to support best practice for those active in research. There will also be a short panel discussion, where attendees can hear directly from the study leads and research participants of studies, as well as organisations, working creatively and progressively in this area. Abbvie Chief Scientist Office Scotland F1000 ISRCTN Registry Register for the workshop
  6. 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
  7. Content Article
    The webpage includes information on: Secure workspaces Searching for clinical trials Training and support Legal framework Transition period
  8. 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
  9. 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
  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
    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
  12. 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
  13. 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
  14. 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
  15. Content Article
    It is well established that menstrual and menopausal hormones interact with certain medications. Varying levels of reproductive hormones throughout a woman’s menstrual cycle and lifespan have resulted in women historically being excluded from clinical trials. Female bodies have been perceived as ‘too hard’ and costly to research and, perhaps, unworthy of the effort. Author of ‘Invisible Women: Exposing data bias in a world designed for men’ Caroline Criado Perez argues that “When [women] are included in tests they tend to be looked at in the early follicular phase of their menstrual cycle, when hormone levels are at their lowest – i.e. when they are superficially most like men. Most medical trials are done on male cells even though female cells react differently.”[1] But this approach has a major flaw – evidence gathered about the safety and effectiveness of a medication will not apply to a patient group that it has not been tested on. Different metabolism of medications between men and women is to be expected, as male and female bodies are biologically different, right down to the cellular level.[2] Lower body weight, slower digestion, less activity from intestinal enzymes and slower filtration by the kidneys are all factors that cause this difference. Medications can also have varying effects depending on the time they are taken in a woman’s menstrual cycle, as well as affecting the menstrual cycle itself. Where we lack data on these factors, we are left with a dangerous knowledge gap that has a real impact on the safety of women within healthcare. A 2020 research study that found that women experience up to twice as many adverse drug reactions as men.[3] Since the 1990s, there has been growing acknowledgement that understanding interactions between medications and female hormones and bodies is essential for patient safety. However, the impact of this historical issue persists; a 2017 research study found that the effects on different sexes of around one-third of drugs were still unknown.[4] If doctors lack information to safely offer and prescribe certain drugs to female patients, informed consent is undermined at its most basic level. A brief history of women and clinical trials Alongside concerns about additional costs[5] and the perceived complexity of including women in general clinical trials, lies the fact that trials for treatments specific to women have received far less funding and attention than those that affect men.[6] Clinical trials that include women of childbearing age have also suffered from a self-perpetuating cycle of inadequacy. Although the lack of appropriate clinical trials led to the thalidomide tragedy of the 1960s in the first place, in its aftermath researchers became more wary of including women of childbearing age in clinical trials. The US Food and Drug Administration even introduced a precautionary ban on women of child-bearing age taking part.[7] But this move perpetuated the issue and had far-reaching consequences for medication safety for women. As the implications of these exclusions became clearer, US regulators made moves to redress the balance and make the case for including women in more clinical trials. In 1990, the US Office of Research on Women’s Health was established, with one of its aims being to “ensure that women are appropriately represented in biomedical and biobehavioral research studies, especially… clinical trials.” In 1993, the US passed a law that meant women could no longer be excluded from National Institute of Health (NIH)-funded research. It is harder to find information on the history of women and clinical trials in the UK, and a 2005 study reviewing clinical trial participation noted that “the issue of exclusion from trials of women, older people and ethnic minorities has been relatively neglected in the UK research community.”[8] The authors highlighted that, in the sample of trials they looked at, “USA trials were more inclusive than UK/European trials,” suggesting that legislating for inclusion makes a difference to representation. Evidence-gaps with serious consequences There are significant patient safety issues associated with this lack of knowledge. Prescribed dosages rarely take into account the sex of the patient,[9] and because male and female bodies metabolise medications at different rates, women may be prescribed inappropriate doses.[3] Women have been found to be more sensitive to beta blockers, opioids, selective serotonin reuptake inhibitors and antipsychotics.[9] The evidence gap is seen starkly in the link between adverse outcomes for women with heart failure and gender bias in research. Between 1987 and 2012, women made up only 25% of participants over 31 landmark trials for congestive heart failure,[1] and the result of this lack of data is that many heart medications are less effective in women than in men.[10] Add to this the fact that women are 50% more likely to be misdiagnosed during a heart attack, and it paints a worrying picture. Rethinking research during pregnancy and breastfeeding One group that has been excluded perhaps more than any other from clinical trials is pregnant women. As the 2020 Cumberlege Review ‘First Do No Harm: The report of the Independent Medicines and Medical Devices Safety (IMMDS) Review’ states, “The risk of teratogenicity has meant women are largely excluded from clinical trials; as a result only a handful of medicines are licensed for use in pregnancy and the safety profiles of newer medicines in pregnancy are initially unknown.”[11] According to a 2011 study, the teratogenic risk in human pregnancy was “undetermined” for 98% of drug treatments approved by the FDA between 2000 and 2010, and the mean time it took for drugs to be assigned a more precise risk was 27 years.[12] This lack of knowledge about medications in pregnancy means that women struggle to make informed choices about the safest course of action for themselves and their babies. The IMMDS Review highlights the stark consequences of this, addressing the harm caused by the hormone pregnancy pill Primodos and the anti-epileptic drug sodium valproate, both of which cause birth defects. Available evidence suggests that valproate, which was used in the UK from 1971, causes physical malformations in 10% of children and autism and developmental delay in 40% of children when taken by mothers during pregnancy. However, “the system does not know” to this day the exact number of children affected by women taking valproate or Primodos during pregnancy. A register for tracking physical malformations caused by valproate was only established in 1996, in spite of concerns being raised about the drug from 1972, and is only a voluntary measure.[11] The suffering and pain caused to mothers, their children and their families by these drugs is unquantifiable. The Covid-19 pandemic has thrown fresh light on the importance of including pregnant women in medical research. The fact that they were largely excluded from testing vaccines and treatments[13][14] meant that pregnant women were left unprotected from Covid-19 for much longer than most of the population, despite being at higher risk of hospitalisation from the virus.[15][16] Pregnant women and their doctors were unable to make informed decisions about the risks posed by the vaccine because the data simply didn’t exist. Great care needs to be taken in deciding whether there is a benefit to including pregnant women in medical research, but the reality is that pregnancy and ill health are not mutually exclusive conditions, as Katherine Shubert of the Society for Women's Health Research notes, “People who are sick or have chronic conditions can become pregnant, and those who are pregnant can get sick or develop health conditions.” So there is a clear need to find out which treatments are effective and safe for pregnant women and their unborn children. In 2017, the US Government established a Task Force on Research Specific to Pregnant women and Lactating Women, which made recommendations and published an implementation plan to address barriers to including pregnant and breastfeeding women in research. In the UK, the recent development of standard definitions and grading for adverse events in pregnant women [17] has the potential to speed up progress in developing new treatments for use during pregnancy. Encouraging women to take part in research studies and clinical trials This narrative that women, particularly pregnant women, shouldn’t take part in medical research may also have the effect of discouraging women from applying to take part. The US NIH has posited that women may be reluctant to take part because of fear and distrust of researchers, lack of knowledge about trials and interference with work or family responsibilities,[18] but there is limited research on the issues women see as barriers, and how to overcome them. Some research shows that women declined more often to participate because they perceived a higher risk of harm from trial participation than men.[19] Under-diagnosis also means fewer women are eligible for trials in certain areas, such as cardiovascular disease.[18] A more balanced future There is a way to go in closing the knowledge gap around sex and medications, but participation has improved over the last decade,[20] and work is being done to balance representation of the sexes in clinical trials. In the UK, the NIHR launched the INCLUDE Project in 2018 to increase participation of underserved groups in medical research, including women of child-bearing age and pregnant women.[21] As part of the 2017 EU Clinical Trial Regulation No 536/2014, trials based in the EU are obliged to ensure “the subjects participating in a clinical trial … represent the population groups, for example gender and age groups, that are likely to use the medicinal product investigated.”[22] Technology is also being used to make clinical trials more representative. An increasing number of trials are being designed to operate ‘virtually’, using remote monitoring and telemedicine to decrease the logistical burden of participating.[23] Some organisations are also using AI to more effectively match candidates to trials,[24] but existing bias will need to be taken into account when developing these algorithms. As we gain more knowledge of the unique ways in which female bodies and hormones interact with medications, there will be an ongoing need to make sure that both doctors and patients understand and can apply this information to use medications more safely. References 1 Gender data gap: Caroline Criado Perez on how healthcare is “systematically discriminating against women”. Evening Standard. 26 September 2019 2 Straface E, Gambardella L, Brandani M et al. Sex differences at cellular level: "cells have a sex". Handbook of experimental pharmacology. 2012:214:49-65 3 Zucker I, Predergast B. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biology of Sex Differences. 2020:11:32 4 Karlsson Lind L, von Euler M, Korkmaz S et al. Sex differences in drugs: the development of a comprehensive knowledge base to improve gender awareness prescribing. Biol Sex Differ. 2017:8:32 5 Ravindran T, Teerawattananon Y, Tannenbaum C et al. Making pharmaceutical research and regulation work for women. The BMJ. 2020:371 6 'Women have been woefully neglected': does medical science have a gender problem? The Guardian. 18 December 2019 7 Fang A. Sex Bias in Pharmacological Studies. The Public Health Advocate. Spring 2021 8 Bartlett C, Doyal L, Ebrahim S et al. The causes and effects of socio-demographic exclusions from clinical trials. National Institute for Health Research. 2005:9:38 9 Whitley H, Lindsey W. Sex-Based Differences in Drug Activity. Am Fam Physician. 2009:80(11):1254-1258 10 Crompton S. Should medicine be gendered? Science Focus. 1 May 2019 11 Cumberlege J. First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review. Crown copyright. 2020. 12 Adam M, Polifka J, Friedman J. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet. 2011:157:175-182 13 Whitehead C, Walker S. Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. Lancet. 2020:395:92 14 Taylor M, Kobeissi L, Kim C et al. Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action. Lancet Glob Health. 2021:9:366-71 15 Zambrano L, Ellington S, Strid P et al. Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–October 3, 2020. Weekly. 2020:69(44):1641-1647 16 Coronavirus infection and pregnancy: Information for pregnant women and their families. Royal College of Obstetricians & Gynaecologists website. Accessed 7 March 2022 17 Spencer R, Hecher K, Norman G et al. Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. Prenat Diagn. 2022:42(1):15- 26 18 Kim S, Menon V. Status of Women in Cardiovascular Clinical Trials. Arteriosclerosis, Thrombosis, and Vascular Biology. 2009:29:279–283 19 van Diemen J, Verdonk P, Chieffo et al. The importance of achieving sex- and gender-based equity in clinical trials: a call to action. European Heart Journal. 2021:42:2990-2994 20 Are medications and medical devices more dangerous for women? Canadian Institutes of Health Research. 18 July 2019 21 Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project. National Institute for Health Research. 7 August 2020 22 Sundseth, H. Right from the Start - Including more women in Clinical Trials. European Federation of Pharmaceutical Industries and Associations. 5 March 2020 23 Longworth C. International Women’s Day: The gender gap in clinical trials. Pharmaphorum. 8 March 2021 24 Sikora S. Intelligent clinical trials: Transforming through AI-enabled engagement. Deloitte Centre for Health Solutions. 2020 Related reading Misogyny is a safety issue: a blog by Saira Sundar The normalisation of women’s pain ‘Women are being dismissed, disbelieved and shut out’ (Stephanie O'Donohue, November 2020) Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies