By Ellie Murphy (Admin and Marketing Assistant at INDICRO)
This blog will be covering the latest updates and changes to the clinical research landscape in the UK, featuring insights from the MHRA (covering CTIMPs and Medical Devices) and the HRA, who both presented at the recent ICR Ethics and Good Clinical Practice (GCP) Forum on April 3rd at UCL. Just a few days later, on April 7th, the UK Government also announced major new investments and initiatives to strengthen the UK’s position as a global leader in medical research.
From regulatory reform and digital transformation to streamlined processes and data access, this blog brings together the key highlights, stats, and practical takeaways — with helpful links to official guidance if you’d like to explore further.
Let’s dive in!
Michelle Gabriel (MHRA GCP Inspector) – UK Clinical Trials Regulation: A New Era
Michelle opened with a refresher on the current regulatory landscape. Her talk focused on the future of UK clinical trials regulation in a post-Brexit world – and let me tell you, change is coming fast.
Key points:
- The new Statutory Instrument (SI) for UK clinical trials has passed through the House of Commons and House of Lords and is expected to be signed into law mid-April 2025.
- There will be a 12-month implementation period before the regulations come into effect (Spring 2026).
- New guidance will be released mid-May by both the HRA and MHRA, with stakeholder consultation beginning next week. Email [email protected] to get involved.
The core goal? To streamline approvals, reduce duplication, and make the UK an attractive environment for clinical research. The UK currently sponsors around 12% of global clinical trials, and these reforms are aimed at maintaining and increasing that share.
One highlight was the emphasis on meaningful patient and public involvement. After 1 April 2025, all new IRAS applications must either:
- Use the new GDPR Transparency Wording Template; or
- Demonstrate how their bespoke wording meets the four principles of meaningful involvement.
Important note: These changes are not retroactive—they only apply to new applications after 1st April.
More on the GDPR template here →
She also spoke about inspection trends, noting that there’s a growing shift towards risk-based inspections. Organisations with weak systems or oversight are more likely to face scrutiny, and reliance on outdated processes is no longer tolerated. Michelle reinforced a clear message: “We’ve always done it this way” won’t cut it anymore.
Key findings included:
- Sponsors need clear oversight and retention by a named archivist of all parts of the TMF especially for eTMFs
- Statistical programming for clinical trial results should be fit-for-purpose and the data lifecycle should be verifiable
- Protocol and material particulars should be clear with regards to decentralised trial designed. PI retains oversight of these activities
- Sponsor should not be able to make changes to PI submitted data for “self-evident” corrections
- Investigators should be provided with audit trails from eCRFs
Mark Grumbridge – (MHRA Medical Devices) Medical Devices Regulation, AI and Tech
Mark walked us through how the MHRA is evolving alongside the new clinical trials regulation. Key takeaways:
- The MHRA aims to simplify and modernise medical device regulation to better reflect the digital-first nature of current innovations.
- Emphasis on flexible, responsive regulation – tailoring oversight based on the risk profile of the product.
- Supporting innovation in digital health through clear guidance and early engagement.
- Mark reviewed the application and approval process for Clinical Investigations in Medical Devices and overview of the Innovative Devices Access Pathway (IDAP).
For more information please visit the links below:
https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
https://www.gov.uk/government/groups/mhra-innovation-office
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
One standout section of Mark’s session addressed the regulation of Software as a Medical Device (SaMD) and artificial intelligence as a medical device (AIaMD)updated Feb 2025. These technologies are growing fast — with AI-related medical device submissions increasing by over 25% in the last year — and regulators are working hard to keep pace. https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device/software-and-artificial-intelligence-ai-as-a-medical-device
He also introduced upcoming technical guidance updates, which will align with the 2025 SI and allow more streamlined regulatory collaboration across departments.
Towards the end of the session, Mark shared a moving story that gave all the technical details a deeply human perspective. Oran, a young boy with Lennox-Gastaut Syndrome (a severe form of epilepsy), had his life dramatically improved thanks to a neurostimulation device implanted in his brain — reducing his seizures by 80%. The study was conducted at Great Ormond Street Children’s Hospital and approved by the MHRA. Subsequently we have seen transformative treatment emerge, serving as a reminder that the MHRA helps shape vital parts of making such life-changing treatments possible. It was a powerful reminder that the work done behind the scenes — in policy, compliance, and regulation — has real-world impacts that can change lives.
If you’d like to watch the video, us the following link, (I would recommend having a tissue to hand if you are anything like me)
Oran’s Story:
Jen Harrison (HRA)Research Systems Programme & UK Clinical Research Delivery
Jen gave us a fast-paced tour of the Research Systems Programme, a major digital transformation led by the Health Research Authority (HRA). This was probably the most future-forward talk of the day, with a strong focus on digitising the end-to-end research journey.
The big plan:
- Digitise and link all research approval systems.
- Let researchers enter data once and use it across multiple services.
- Support every step: from the first spark of an idea to making research public.
Key partners: HRA, NIHR, MHRA, MOD, HFEA, HSC, Wales/Scotland Health Depts, HM Prisons, and more.
Benefits for users:
- Sponsors will have clear version control and get coordinated approvals.
- Researchers can easily amend and set up studies across NHS orgs.
- Organisations will receive standardised info, and track approvals in real-time.
New digital services include:
- Planning & preparing research
- Making changes to approved studies
- Submitting for review & tracking approval
- Managing research delivery
- Publishing research
They’ll be phasing out legacy systems such as IRAS, HARP, TOPS, and others through a staged transition model (Discovery → Alpha → Private Beta → Public Beta).
If you want to help shape these services, they’re actively looking for diverse user testers—especially people new to research, experienced users, and those with accessibility needs.
Find out how to get involved →
Jen Harrison continued… UK Clinical Research Delivery (UKCRD) – Streamlining Set-Up
Finally, Jen touched on the UKCRD programme, which is driving change through a Study Set-Up Plan, co-led by NHS England and the Department of Health and Social Care (DHSC).
Three key priorities:
- Streamline and reform trial set-up through digitalisation and reduced bureaucracy.
- Shift research delivery into primary and community care.
- Move to proactive portfolio management.
Rapid action workstreams include:
- Standardising UK-wide commercial contracts.
- Removing duplicate reviews (Pharmacy, Radiology, Info Gov).
- Improving data granularity for study performance.
- Introducing a single UK model for costing and contracts in non-commercial studies.
They’re also piloting Pharmacy Technical Assurance (TA) with ECMC and HRA—helping sites reduce repetitive sponsor queries with peer-reviewed info earlier in the process.
Government Announcement: What’s Happening in the UK Right Now?
The UK government’s announcement on 7th April to “turbocharge” medical research is part of a broader strategy to make Britain the best place for medical innovation, with the goal of driving economic growth and creating well-paid jobs. Key measures include:
• A £1 billion investment to accelerate health and life sciences.
• Fast-tracking clinical trials to reduce setup times from over 250 days to 150 days by March 2026.
• Investment of up to £600 million with the Wellcome Trust to create a Health Data Research Service, improving access to NHS data and cutting red tape for researchers.
• Plans to enhance the Oxford-Cambridge Growth Corridor and accelerate the discovery of life-saving drugs.
Janet Valentine, Executive Director of Innovation and Research Policy at ABPI, said:
“The scale and ambition of the Prime Minister’s announcement today shows he understands the huge opportunity for the UK to be a global leader in clinical research, and that unlocking research access to health data and speeding up the set-up of clinical trials are fundamental to achieving that goal. Public and patient confidence in the responsible use of health data will be critical to the success of the service, which is why the government is right to work closely with a trusted partner like the Wellcome Trust. To make the most of this opportunity, it will be essential to build on the existing strengths and expertise within the UK health data system. It will also be vital that the pharmaceutical industry, as a major investor in research and development of innovative medicines, plays an integral role in the design and implementation of the new health data research service.”
At INDICRO, we’re excited to see how these initiatives will benefit our community of freelancers, life sciences companies, and service providers. Through our Lunch & Learns, discussion forums, and innovation-driven platform, we’re here to help you navigate these changes.
To learn more, drop us an email at [email protected] or sign up for one of our monthly ‘INDICRO: How it Works’ webinars via our LinkedIn profile.
For full details, read the article here: Prime Minister turbocharges medical research.
Final Thoughts
This event brought real energy and momentum to the room. From regulatory reform to end-to-end digital systems, the future of UK clinical research is heading towards a faster, fairer, more streamlined space.
As someone starting out in this field, it was encouraging to see such a strong focus on inclusivity, transparency, and above all, practical solutions.
If you’re keen to get involved or stay in the loop, I’d highly recommend signing up for stakeholder updates, volunteering for testing, or just keeping an eye on the HRA newsfeed. There’s a lot happening – and it’s happening fast!
(And if there’s one thing we learned? Bring tissues to a talk about epilepsy devices — compliance can be emotional too.)
