A New Year, a New Future for UK Trials

Posted on: Thursday 6 February 2025
Author: Stuart Dollow, Frank Gray and Kirsty Wydenbach with input from the FPM Clinical Trial Science and Regulations Expert Group

How to cite: Dollow, S. et al (2025), ‘A New Year, a New Future for UK Trials', Faculty of Pharmaceutical Medicine, 4 February 2025. Available at: [INSERT LINK]

The article presents the views of the authors and not necessarily those of the Faculty of Pharmaceutical Medicine.

A Transformative Year for UK Clinical Trials

The Medicines and Heathcare products Regulatory Agency (MHRA) provided news that seemed a fitting end to 2024: notification that the new clinical trials legislation had been laid in parliament on 12 December 2024. The aim is a more efficient, streamlined and adaptable regulatory framework for clinical trials in the UK that will hopefully provide sufficient change to enable a boost to the UK as a go-to place to do drug development and ultimately benefit UK patients. The updated regulations are currently being debated and will come into force in early 2026 after a 12-month implementation period. The legislation will come with new guidance documents, replacing the existing CT1 and CT3 guidelines, which are currently used in the UK. [CT1 and CT3 are specific regulatory guidance documents related to compliance and procedures in clinical trials.]

So why does this matter? Well, companies will need to keep a close watch on the final wording of the legislation and guidance to prepare for future clinical trial authorisation applications, but more importantly, it could provide a way to differentiate the UK and attract more trials. The MHRA will likely hold webinars and produce helpful information outside the guidance to help prepare for the transition, so signing up for MHRA notifications would seem a good plan.

As individual pharmaceutical physicians, it will clearly impact those directly involved in regulatory affairs or in frontline clinical research the most, but the updated legislation is only a part of other wider changes that will influence clinical research conduct in the UK. This includes the recently adopted ICH E6(R3) [Guideline on Good Clinical Practice, Step 4, 6 January 2025], which still has work to be progressed on Annex 2. A previous blog has also laid out some other clinical research areas that may impact FPM members, much of which is still relevant now.

Key Reforms: What’s Changing and Why?

As outlined by Baroness Merron and Andrew Gwynne to the House of Lords and House of Commons, these reforms will:

  • Create a proportionate and flexible regulatory environment – the new legislation will empower researchers to take more risk-appropriate approaches to trials, meaning the regulatory requirements will be more flexible to match the risk that a trial presents.
  • Cement the UK as a leading destination for international trials – the new legislation will introduce more streamlined and efficient application processes, making it easier to apply for trials in the UK without compromising on safety standards. A combined regulatory and research ethics review will be brought into legislation, and approval timelines will be internationally competitive.
  • Moving away from a one-size-fits all approach to being responsive to innovation – the new legislation has been drafted to ensure it is as future-proof as possible and is responsive to different types of trials and innovative ways of carrying out trials. Guidance will be used for specific details rather than granular and duplicative requirements in legislation.
  • Ensure patients and their safety are at the focus of all clinical trials and supported by greater transparency, bringing the benefits of clinical trials to everyone. The new legislation will ensure increased public transparency about trials, including a requirement for registration on a public database and sharing of trials results with participants.

Many areas will be unchanged, some will put processes already utilised into formal legislation (such as the combined review process: the single submission to the MHRA and Research Ethics Committee), and some aspects will be new (including the transparency rules). The focus on a more risk-proportionate approach to clinical trial approvals is evident. It parallels strengthening a streamlined risk-proportionate approach taken when updating the International Council for Harmonisation Guideline for Good Clinical Practice (ICH GCP)[the ICH GCP is an international standard for clinical trials]. The updated notification scheme (‘notifiable trials’) is particularly highlighted here as this may impact trial sponsors more than currently. However, this may depend on further clarification and detail in the guidance once available.

Boosting Innovation and Global Competitiveness

Much has already been commented on, not just regarding the updates to the legislation but also the wider research environment in the UK. The annual reports from the Association of the British Pharmaceutical Industry (ABPI) are notable, and the 2024 report was no exception, providing an honest summary. The report points out that whilst the UK has made gains in the rankings for phases II and III, its position has fallen for Phase I. This will be no surprise to the Phase I community, which has also seen shortened timelines for MHRA review disappear in recent years and a notable absence of specific support in the new legislation. The report is not completely bad news and highlights how diversity and inclusion plans for research in the UK are ahead of other countries. The economic benefit to patients, the NHS, and the broader UK economy remains significant: UK industry clinical trials delivered £7.4 billion of Gross Value Add in 2022, supported 65,000 jobs, and bought the NHS £1.2 billion in revenue. However, The ABPI still make six crucial recommendations to increase momentum and restore the UK’s position in the global environment.

The recent changes in the UK have also been the subject of other recent publications, including a comparative analysis of pre-and post-Brexit by Arora et al. The aim was to understand the competitive position of the UK in comparison to Europe and the USA for haematological cancer clinical research. Still, the conclusion could easily apply to almost any other indication. The authors conclude, ‘While research in the UK remains among the highest quality and value globally, the UK may be losing its position globally as an attractive destination for executing clinical trials. This may be a trend that is recognised by the UK Government, but it is vital to reverse the trend of clinical trial decline and to improve the economic outlook for the UK and patient early access to innovative cancer medicines.’

Challenges and the Road Ahead

Looking back to past FPM blogs, the summary in June 2023 in particular, FPM members could easily be forgiven for thinking nothing has changed. They may be right in many ways, but with new legislation and a renewed focus on UK clinical trials, we can see that the changes have the potential to start to have a genuinely positive impact in the UK. However, the potential impact of the legislation needs to be holistically viewed in context of the entire pharmaceutical environment that may influence decisions to invest in the UK. Examples include: the recent ‘VPAG clawback’ discussion; the UK’s low spending on medicines and slower adoption of innovative treatments compared to other similar countries and impact of perceptions, media reports and political discussion of a ‘broken NHS.’

FPM will closely monitor all angles and invite members to provide feedback and comments on areas where we can influence policy and work with industry partners to put the UK back on the research map.

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