UK clinical trial sector progress ‘remarkable', says former health minister
Two years on from the publication of his review, and on Clinical Trials Day (20 May), O'Shaughnessy said that the Medicines and Healthcare products Regulatory Agency (MHRA) is once again taking a global lead.
'The progress the MHRA has made in the two years since I published my review has been remarkable. Despite its global reputation for excellence, by 2023, trial approval set-up times had slipped badly,' O'Shaughnessy said.
'The MHRA is now delivering consistently good approval times while introducing further reforms to add speed and flexibility to the process. With a clear mandate from the prime minister to reduce trial set-up times to 150 days, which would be genuinely world-leading, the MHRA is once again taking a global lead.'
Lord O'Shaughnessy became a well-known name in the clinical trial sector after his review was published in May 2023. The review made 27 recommendations where action should be taken by the government and delivery partners, including the MHRA, to address key challenges and transform the UK's commercial clinical trials environment.
MHRA chief executive Lawrence Tallon also reflected on the new regulations by the agency, which help to create patient-centric trials and provide a faster and more streamlined approval system.
Tallon said: 'The UK is already a research powerhouse driven by innovation, with one in eight trials in the UK testing treatments in humans for the first time.
"But we want to go further. Last month, we began implementing the most significant update to UK clinical trials regulation in over two decades. These reforms will address the research sector's need for a more risk-proportionate regulatory framework for clinical trials and will help get cutting-edge new treatments to the NHS as quickly as possible.'
Last month, the MHRA placed the UK as a global leader in clinical trials once again following a collaborative report with the University of Liverpool, which was published in the British Journal of Clinical Pharmacology.
On top of April's regulation, which was first announced in December 2024, the MHRA is launching a six-week consultation on the use of real-world data (RWD) for external control arms of clinical trials, which has the potential to help accelerate the approval of treatments, especially when randomised controlled trials may not be ethical or feasible.
The new guidance is for those planning a clinical trial that may include an RWD external control arm to support a regulatory decision on a medical product.
In April 2025, the UK Government announced it would invest £600m ($764m) into a new Health Data Research Service to support researchers. The investment will provide researchers with a secure access point to national datasets to be used in research.
The regulation implemented last month should reduce unnecessary administrative burdens on trial sponsors without compromising patient safety. They are also designed to protect trial participants, facilitate the development of new medicines, remove obstacles to innovation, and ensure that legislation enables trial sponsors to work across countries.
The legislation is part of a broader overhaul by the MHRA, supported by health system partners including the Health Research Authority (HRA), academia and researchers.
The new regulations will be accompanied by guidance from the MHRA and HRA to embed meaningful public involvement in clinical trials and increase participant diversity. The regulatory bodies hope this will demonstrate the UK's potential as a research base that can improve care and minimise health inequalities.
The MHRA has also improved its processing of clinical trial applications, with 100% of clinical trials and investigations applications having been handled within statutory timescales since September 2023.
"UK clinical trial sector progress 'remarkable', says former health minister" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Medscape
2 minutes ago
- Medscape
Vaccine Skepticism Is Spreading, but You Can Turn the Tide
Vaccines today prevent or significantly reduce the impact of around 30 dangerous and potentially life-threatening diseases. Consistent vaccination programs have been crucial in ensuring that most of these illnesses no longer pose a public health threat, as a large portion of the population is immunized before encountering the infections. Vaccines and vaccination programs thus represent one of the greatest success stories in infectious disease prevention. However, few medical interventions spark as much skepticism in certain populations as vaccination. The specific effects of these doubts — ranging from hesitancy about particular vaccines to outright refusal — are hard to quantify, especially because other factors can also lead to low vaccination rates. For example, conducting vaccination campaigns in crisis or war zones remains challenging, even when sufficient vaccine supplies exist and most eligible people want to be vaccinated. Threat to Infectious Disease Control It is well-established that diseases such as polio and measles could be eradicated through consistent immunization of a sufficiently large segment of the population. Likewise, severe illness among especially vulnerable individuals — who cannot be vaccinated due to medical reasons — can be prevented through herd immunity, thereby reducing individual suffering. Yet, those with skeptical or anti-vaccine views often ignore or deny these facts. Instead, they argue that vaccination is a personal decision to be made solely between the individual and their healthcare provider. In this view, national vaccination plans designed to protect both individuals and the community are given lesser importance. Not Without Consequences In 2019, before the COVID-19 pandemic brought renewed focus to vaccination, the World Health Organization (WHO) identified vaccine skepticism as one of the top 10 global health threats. The WHO defines vaccine skepticism as the 'delayed acceptance or refusal of vaccines despite the availability of vaccination services.' Experts at WHO are particularly concerned that such skepticism threatens to reverse significant progress made in recent decades against vaccine-preventable diseases. Despite numerous efforts to educate the public objectively about vaccines and increase acceptance, vaccine-skeptical views continue to gain influence in societal discourse and among decision-makers worldwide. Social media plays a key role in this trend. Misinformation can spread rapidly and often goes uncorrected, amplifying fears and bringing latent anxieties to the surface. These platforms act as multipliers: Individuals who have long harbored vaccine skepticism find their concerns reinforced by reports of potential dangers from supposedly insufficiently tested new vaccines, while those previously neutral or positive about vaccination become uncertain. Both groups share their fears and false beliefs, fueling further spread within networks of similarly doubtful people. COVID-19 as a Catalyst Vaccine skepticism and opposition are not new — they have existed since the earliest days of vaccination. Edward Jenner, the English country doctor who administered the first smallpox vaccine in 1796, faced resistance despite the widespread acclaim for his discovery. By 1866, the first organized anti-vaccination group, the British 'National Anti-Vaccination League,' had formed. Opponents feared vaccination might cause more harm than good. Caricatures depicting people growing cow heads from their arms after vaccination circulated, and early anti-vaccine publications appeared. Since then, criticism and opposition have accompanied nearly every new vaccine introduced. The COVID-19 pandemic significantly accelerated the spread of anti-vaccine content, acting as a catalyst for alarmist and conspiratorial narratives that had previously remained largely under the public radar. With COVID-19, organized anti-vaccine movements gained unprecedented visibility and influence. The effects have been long-lasting. In vulnerable populations, vaccine myths not only influenced decisions regarding COVID-19 vaccination but also fueled broader skepticism toward vaccines in general. Experts are now exploring ways to reverse this trend. Recent research into modifiable underlying attitudes and concerns across different populations offers promising avenues for intervention. Modifiable Risk Factors A mixed-methods study conducted by doctors and psychologists from the universities of Oxford and Oslo, involving comparable populations from Norway and the UK, identified five key modifiable risk factors associated with COVID-19 vaccine skepticism: The illusion of invulnerability, Doubts about vaccine effectiveness, Distrust of (health) authorities, Downplaying the societal impact of COVID-19, and Health-related fears concerning the vaccine. These risk factors have strong predictive value and can be strategically addressed by public health organizations to reduce vaccine hesitancy. Both vaccine opposition and hesitancy stem largely from misconceptions about the actual risks, benefits, and potential side effects of vaccines and their adjuvants. Most people who remain undecided do not reject vaccines out of firm conviction. There are multiple opportunities to address uncertainties and counter misinformation with well-founded evidence. Traditional educational approaches have proven to be as effective as newer motivational interventions aimed at increasing personal motivation to get vaccinated. Both strategies have helped raise vaccination rates. However, there is still a lack of high-quality studies evaluating the effectiveness of motivational methods in more detail. Can Anti-Vaccine Movements Be Reversed? Anti-vaccine activism is not confined to the general public; even some healthcare professionals are susceptible to vaccine skepticism and may inadvertently contribute to the spread of misinformation — often via the same channels as nonexperts. When such views come from medical professionals, the impact is especially damaging. The high credibility generally afforded to doctors lends greater weight to their vaccine-related statements than those from former classmates or alternative medicine practitioners. The spread of false or biased information about vaccines amounts to an attack on science itself — a reality that many fail to recognize. Medical assessments of vaccines, adjuvants, or new vaccine technologies are sometimes deliberately downplayed or misrepresented to bolster anti-vaccine narratives. These groups use such claims to suggest contradictory scientific opinions on vaccines exist, despite a clear consensus among experts supporting vaccination. Recent developments in the US highlight the dangers of coordinated misinformation. In June, all 17 permanent members of the Advisory Committee on Immunization Practices were dismissed and partially replaced with known vaccine critics and underqualified individuals. Experts have warned that this move severely undermines trust in the committee's future recommendations. It is concerning that even health authorities can fall under the influence of anti-vaccine groups, with real consequences for official vaccine policies. While such scenarios remain unthinkable in Germany and other European countries, it is crucial to proactively resist attempts at influence, counter misinformation, and communicate the scientific basis of vaccine decisions clearly and accessibly. Doctors and healthcare professionals often lack the time to provide detailed information and persuasion to vaccine-skeptical individuals or those unsettled by misinformation. However, in many cases, extensive information isn't necessary — simply highlighting the health benefits of vaccination and directing patients to reliable online resources can be sufficient. For example, the Robert Koch Institute, Berlin, Germany, offers alphabetically organized, easy-to-understand information from the German Standing Committee on Vaccination on each available vaccine, along with answers to frequently asked questions, under the title ' Vaccinations AZ.' Making Vaccines More Accessible Another often overlooked factor in vaccine hesitancy is that missed vaccinations can result from a lack of information, misunderstandings, or simply forgetting appointments. Limited language skills may hinder understanding of vaccine information, while patients might hesitate to ask questions. Multilingual brochures can help by enabling patients to review information at their own pace and raise queries at follow-up visits. In Germany, for example, the current vaccination schedule is available in 10 languages. Physicians can also help reduce missed appointments by setting up automatic reminders via apps, email, or short message service. Since 2025, vaccination records for all insured individuals have been accessible through the digital vaccination pass, unless the individual opts out. Patients can also enroll in personalized vaccination reminder services to stay on schedule.
Yahoo
an hour ago
- Yahoo
Why Cardinal Health Stock Was Tumbling on Tuesday
Key Points It was a busy day for the company, which unveiled a fresh set of quarterly results and announced a pricey acquisition. It should soon own around three-quarters of Solaris Health. 10 stocks we like better than Cardinal Health › Sprawling healthcare company Cardinal Health (NYSE: CAH) reported its latest quarterly results and announced a sizable new acquisition Tuesday morning. The market didn't take these news items well, however, and in late-session trading, it was pushing the company's share price down by nearly 7%. The S&P 500 index, meanwhile, was bouncing higher with a more than 1% gain. A nearly $2 billion move Of the two pieces of news, that of the acquisition was clearly the more impactful. Cardinal Health announced that its The Specialty Alliance multiservices organization (MSO) platform has signed an agreement to acquire Solaris Health. The latter company was described by its acquirer as "the country's leading urology MSO." Cardinal Health will pay roughly $1.9 billion in cash to Solaris' owners (comprising a firm known as Lee Equity Partners and the company's physician partners) to acquire around a 75% stake in the business. In the press release trumpeting the deal, Cardinal Health said that it would bolster the scale of urology within The Specialty Alliance. The company said it would finance the acquisition with cash on hand plus new debt. It expects the deal to close by the end of this calendar year. Separately, Cardinal Health reported its fiscal fourth quarter of 2025 results. Revenue was basically flat year over year at just under $60.2 billion. Non-GAAP (adjusted) net income, on the other hand, rose by 11% to hit $501 million, or $2.08 per share. On average, analysts tracking the stock were modeling $60.9 billion on the top line yet only $2.03 per share for adjusted net income. Flying higher with guidance Cardinal Health also raised its profitability guidance for the entirety of fiscal 2026. The company is now forecasting that adjusted earnings per share will come in at $9.30 to $9.50; its previous estimate was $9.10 to $9.30. That $9.30 at the low end of the new range is 13% higher than the actual fiscal 2025 result. The company did not provide revenue guidance. Do the experts think Cardinal Health is a buy right now? The Motley Fool's expert analyst team, drawing on years of investing experience and deep analysis of thousands of stocks, leverages our proprietary Moneyball AI investing database to uncover top opportunities. They've just revealed their to buy now — did Cardinal Health make the list? When our Stock Advisor analyst team has a stock recommendation, it can pay to listen. After all, Stock Advisor's total average return is up 1,060% vs. just 182% for the S&P — that is beating the market by 877.59%!* Imagine if you were a Stock Advisor member when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $653,427!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,119,863!* The 10 stocks that made the cut could produce monster returns in the coming years. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of August 11, 2025 Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Why Cardinal Health Stock Was Tumbling on Tuesday was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
an hour ago
- Yahoo
Cat dementia is similar to human Alzheimer's disease ...Tech & Science Daily podcast
Listen here on your chosen podcast platform. Cats develop dementia similarly to humans with Alzheimer's disease. Scientists hope their findings lead to new treatments for both humans and our feline friends. For more, we spoke to the lead author, Dr Robert McGeachan, at the University of Edinburgh's Royal School of Veterinary Studies. A swarm of jellyfish forced the shutdown of France's largest nuclear power plant, Gravelines. But how unusual is this event? And, Reddit blocks the Internet Archive's Wayback Machine from archiving large portions of its site. Also in this episode: -How blowing through a conch shell could alleviate the symptoms of obstructive sleep apnoea -Lola Young urges Keir Starmer to block Rosebank oil and gas development projects -Natalie the Nerd builds a transparent GameBoy Colour
