UK clinical trial sector progress ‘remarkable', says former health minister
The progress the UK has made as a global contributor to clinical trials is 'remarkable', says Lord James O'Shaughnessy, former health minister and author of the landmark report into the domestic commercial clinical trials sector.
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
Bloomberg
2 hours ago
- Bloomberg
DHL to Invest €500 Million on Africa, Middle East Expansion
Logistics giant DHL Group plans to invest about €500 million ($575 million) in health-care services in Africa and the Middle East over the next five years to capitalize on China's push into the regions. The German company is looking particularly at Africa for growth opportunities, with time-critical shipments of vaccines, stem-cells and cryogenics all target areas, EMEA health-care head Annette Naude said in an interview.
CBS News
2 hours ago
- CBS News
Wheat Ridge to allow freestanding emergency care facility to be built on Wadsworth corridor in the Colorado city
At June 9's Wheat Ridge City Council meeting, an ordinance was passed that effectively paved the way for freestanding emergency departments to be built and operate within the city limits. CBS One such area is slated to be on the corner of 38th Street and Wadsworth Boulevard. "(This) for the first time allows freestanding emergency departments to be built in mixed use zones," said Dan Larson, Wheat Ridge's District 4 Councilor. Freestanding emergency departments -- also known as freestanding emergency rooms -- are effectively emergency care facilities not attached to a hospital. If someone is dealing with a life threatening condition, first responders can take them to a facility like this before deciding if they will send them further to a full-service hospital. The condition of giving this lot of land to HCA Healthone, who operate Rose Medical Center in Denver, is that the freestanding ER also be a part of a larger medical campus in the adjacent plaza on 38th. The total size of the lot is about 5 acres. While the ordinance passed in a council meeting on Monday, it wasn't without some resistance from residents and health care professionals. One big issue revolved around individuals' understanding what freestanding ERs actually are. "It cannot and does not provide a level of care to the level of a real hospital and many of your elderly especially at Wheat Ridge," said Douglas Martel, a former cardiologist at Intermountain Lutheran, during public comment. Critiques like his specifically revolved around cardiac emergencies like heart attacks or strokes. Freestanding ERs, he argued, were not capable of handling those types of emergencies the same ways that full service hospitals are and thus might confuse potential patients and lose them precious time to be treated. "If you want to keep excellent care in your community and for your constituents you will oppose this ordinance," Martel advocated. Other issues from residents included billing and insurance coverage as well as accessibility. Freestanding ERs built a reputation in the early 2010s for "being predatory," as Larson put it, to patients with exorbitant costs that they didn't account for until after treatment. Councilman Larson told CBS Colorado that a big reason the freestanding ER was on the table was because of Intermountain Lutheran's move to the west side of town, creating a need for an emergency care center on the east side. Additionally, Larson said, the regulatory standards for these types of clinics had been changed, allowing Wheat Ridge to not worry about having too many of these services in ways others have. "The regulatory environment in the state of Colorado in terms of licensing, in terms of building practices has changed," Larson said. "The city of Wheat Ridge has changed."
Medscape
3 hours ago
- Medscape
Fast Five Quiz: Opioid Use Disorder
Opioid use disorder (OUD) currently impacts approximately 16 million people worldwide. It is considered a significant public health issue, with experts noting a 'burden that is increasing' globally. As research into optimal management of OUD evolves, updates to clinical guidelines emphasize a more individualized approach to pharmacologic treatment, psychosocial support, and special considerations for specific patient populations, such as pregnant individuals. However, OUD remains a complex disease that comes with many serious health and legal concerns for both patients and clinicians. What do you know about OUD? Check your knowledge with this quick quiz. Despite pharmacologic treatment being known to be highly effective for treating OUD, a CDC report states that 30% of patients with OUD who require OUD treatment received only nonpharmacologic treatment. Further, 43% of patients did not perceive a need for OUD treatment at all. In this significant report, males aged 35-49 years were most likely to receive OUD treatment with medications, while females and younger and older adults had lower rates of access to pharmacologic interventions. The CDC concluded that engaging patients needing OUD treatment with pharmacologic interventions is 'essential.' Learn more about essential statistics for OUD. Data from a predictive-model study indicate that service setting was the strongest predictor for premature discontinuation of OUD treatment. The strength of this predictor declined with length of stay, becoming negligent after 365 days. Other system-level factors such as geographic region, primary source of payment for treatment, and referral source were also strong predictors of early discontinuation; individual factors such as age of first use, sex, and race were less predictive. Previous research cited by the study has also stressed the importance of reducing system-level barriers to care, and the updated federal guidance for opioid treatment programs have expanded access in several ways. Learn more about OUD guidance. Precipitated withdrawal can occur when transferring a patient from methadone to buprenorphine due to buprenorphine being only a partial opioid agonist; as such, the traditional method of transfer involves putting the patient in a controlled, moderate withdrawal state before initiating buprenorphine therapy. However, a novel dosing strategy called microinduction, which involves starting buprenorphine at submilligram doses (or 'low-dose induction'), and cross-tapering with methadone can prevent precipitated withdrawal. Additionally, this method is ideal for patients who want to switch from methadone to buprenorphine and those with chronic use of intravenous or intranasal fentanyl. A recent systematic review found that microinduction and traditional transfer methods had similar rates of successful induction of buprenorphine at 95.6%. Learn more about safe withdrawal practices for OUD. Both the CDC and the latest American Society of Addiction Medicine (ASAM) guidelines specifically state that pharmacotherapy for OUD should be offered as early as possible in pregnancy to prevent harms to both the patient and the fetus, noting that pharmacotherapy for OUD has been associated with improved maternal outcomes. ASAM specifically states, 'increasing the dose or split dosing is often required, especially in the third trimester.' Federal guidelines emphasize that pregnant individuals seeking treatment for OUD are considered a priority for enrollment in opioid treatment programs. Once receiving treatment, they do not generally recommended medically supervised withdrawal from pharmacotherapy for pregnant patients as it might harm the fetus and patient; further, ASAM guidelines state that patients who undergo medically supervised withdrawal are at an increased risk for 'return to opioid use.' However, if a patient decides to proceed with medically supervised withdrawal, ASAM guidelines suggest physicians provide education and resources regarding associated risks. The CDC also specifically recommends against abruptly discontinuing opioids during pregnancy, citing data and resources from the American College of Obstetricians and Gynecologists and the Substance Abuse and Mental Health Services Administration. Learn more about OUD. Federal guidelines specify that opioid treatment programs must conduct at least eight random drug tests per year on their patients. These tests must use FDA approved products that test for commonly abused substances that might affect patient safety, recovery, or adherence to OUD treatment. ASAM affirms this requirement, noting that many patients might need more frequent testing and that eight tests per year 'should be viewed as a minimum.' Learn more about drug testing in OUD. Editor's Note: This article was created using several editorial tools, including generative AI models, as part of the process. Human review and editing of this content were performed prior to publication.
