Winds of change

Stakeholders and policymakers came together at the start of October to discuss priorities for medicine regulation in the UK

© Fernando Zhiminaicela/Pixabay

© Fernando Zhiminaicela/Pixabay

Westminster Health Forum held its latest event on 2 October to examine the priorities for medicine regulation in the UK.

The webinar, attended by more the 70 delegates, heard from Dr Karen Noble, director of research policy and innovation for Brain Tumour Research. She told delegates that the UK needs a better user-friendly registry or a finder for clinical trials to support clinicians. 

She said: ‘It's very difficult for the clinicians to know what's going on and, therefore, is even more challenging for the patients to be able to understand what clinical trials might be relevant for them.

However, Dr Noble told delegates there is ‘some sunshine' on the horizon. Scott Arthur has taken his Rare Cancers Bill, which aims to improve outcomes for patients with cancers that affect less than one in 2,000 people, through the House of Commons and now to the House of Lords. He wants to set up a national specialty lead and dedicated registries to improve trial access for patients.

She told the webinar that the UK needs to improve processes, from taking tissue to making it, making sure it is stored appropriately, and then making sure that the genome sequencing is happening in a timely and speedy manner, and that there are enough staff to be able to interpret those results. 

Jane Morrin O'Rourke, senior policy manager at Health Research Authority (HRA), gave delegates some background on the work the organisation has been involved in to improve the future of clinical research delivery. This work is known as the UK Clinical Research Delivery Programme and also links with upcoming changes to clinical trial regulations. 

The initiative decided that explicit guidance would be better placed to address inequalities and to ensure the flexibility needed to reflect the different types of clinical trials and participant populations. 

O'Rourke said: ‘We've developed four questions that we're asking researchers and sponsors to consider. These questions will form the basis of what we're calling an inclusion and diversity plan, which we are recommending researchers and sponsors create early in the development of their research.' 

An informal consultation was held on the first draft of the guidance at the end of last year, which received more than 300 responses. The HRA has now created a second draft of the guidance. In addition, a pilot has been launched, which asks sponsors and researchers to volunteer to develop an inclusion and diversity plan and submit that as part of an application for review by a research ethics committee. The pilot is expected to close towards the end of 2025.

The event also heard from Dr Louise Crisdale, associate professor in pharmacology at the University of East Anglia, who discussed how the preparedness of the workforce is as important as regulatory innovation. 

She highlighted that educational design must align with the strategic service transformation plans, not just today's guidelines. 

Dr Crisdale said: ‘Genomics and AI-supported prescribing aren't just research frontiers; they're fast becoming clinical norms. We must ensure a prescribing workforce is not only authorised, but also prepared to deliver safe, effective and personalised treatments in real-world settings, and that starts not with the medicine, but with the people trusted to prescribe it.' 

The webinar concluded with Julian Beach, interim executive director of healthcare quality and access at the MHRA. He told delegates: ‘For me, one of the most important considerations is involving our patients and the wider public in this discussion. We can't think that we can do it without that.'

Beach added: ‘There is an absolute willingness and desire to do something different, and that's from within the agency and broader. MHRA is looking front and centre to drive this, but collaborate and bring everybody along with us, so that we deliver.'

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