For many of us the last week before Christmas involves frantic last minute shopping, and coming up with ever more elaborate ideas for Elf on the Shelf. For some, it can also be a really difficult time of year.
For us all, this is a time to reflect on the year just passed, and recharge for the year ahead.
It’s one of my favourite times of the year for many reasons, but also because I take some time to look back and reflect on all of the amazing things we have achieved during 2024.
To say it has been a busy year in government and the NHS would be an understatement, but 2024 has seen a huge amount of change, particularly in health and social care research.
Support for our work
We began the year reflecting on the recommendations made in Lord O’Shaughnessy’s independent review of commercial clinical trials in the UK at the end of 2023.
This was followed up by the government’s response to the Tickell Review in February 2024
Both reviews strongly resonated with our own work, to transform the regulation and governance of research, making it easy to do research that people can trust. The message was clear, however. We all needed to do more to help speed up the approval process, and make it easier to set up research in the UK. This is something that was already in our strategy and reaffirmed our priorities for the year. We welcome the recognition of our efforts, and the encouragement to go further and faster.
Looking back at how we responded I’m immensely proud of everyone at the Health Research Authority, and grateful for the support of the HRA community and our partners.
Our incredible volunteers
During 2024 100% of Clinical Trials of Investigational Medicinal Products (CTIMPs) were reviewed by a Research Ethics Committee (REC) within our 60 day target. That’s a phenomenal achievement, and exactly what the research community told us they needed from the HRA – a predictable and fast service that they can rely on.
To put this achievement into context RECs in the UK met over 1,300 times and reviewed nearly 4,000 applications in 2024. That’s almost 11 applications reviewed every day. Add to that over 7,500 substantial amendments reviewed by a REC and you get a taste of just how busy it has been.
Alongside this the Confidentiality Advisory Group (CAG) have reviewed 144 applications and 63 amendments across 40 meetings.
It’s an extraordinary feat, but what makes it even more special is that our REC and CAG members are all volunteers. This isn’t their day job.
Our REC members alone spent 75,000 hours during 2024 volunteering their time. That’s 85 hours per REC member.
We absolutely could not function as an organisation without them and on behalf of everyone at the HRA I want to say a huge thank you to them for their time, expertise and outstanding commitment.
I also want to acknowledge the difference that they are making. Their hard work helps to create a system where people can be both able and confident to choose to take part in research, meaning that research findings can improve all of our care faster.
There’s of course a whole range of people at the Health Research Authority involved in supporting our committees and providing expert review of research – it’s a real team effort.
Change of government
One of the biggest changes this year was of course the election of a new government.
The Labour Party’s manifesto made a commitment to continue the work to implement the recommendations made by Lord O’Shaughnessy. The government has also made it clear that they want the UK to be a world leader in clinical trials and recognised the importance of life sciences to the health of the nation and growth of our economy.
One of the first actions taken by the government was to commission an independent investigation of the NHS in England. The investigation was led by Lord Darzi and laid out some hard truths for the NHS.
It was great to see that innovation and research were highlighted as areas that can play a key role in transforming the NHS.
We are focused on making it easier to do research in the UK that people can trust.
This year we have launched a new toolkit to support research that is carried out in more than one country in the UK. Alongside this we have rolled out new Participant Information Quality Standards, updated GDPR templates for sponsors to use to ensure consistency and introduced a range of new template agreements to support changes made as part of NCVR.
We also published the results of our People-Centred Clinical Research project which made a series of recommendations for how to improve clinical research for participants.
There are already early signs of improvement which are promising.
The Association of the British Pharmaceutical Industry (ABPI) recently published their annual review of clinical trials in the UK which showed that the UK has improved its global ranking for Phase II and Phase III clinical trials, as well as increasing the number of clinical trials initiated in the UK.
Looking ahead to 2025
The next 12 months will see lots of exciting changes for health and social care research in the UK.
The updated Clinical Trials regulations were laid before parliament on 12 December and we expect it to be debated in the new year. This is something we have been working on with the Medicines and Healthcare products Regulatory Agency for more than two years and will help streamline and speed up clinical trials in the UK.
Following approval there we will be a 12 month implementation period where we will be developing guidance to accompany the new regulations before they come into effect in early 2026.
On a personal note, I’m delighted that the regulations will see it become a legal requirement to register clinical trials in a World Health Organization (WHO) recognised public register, and to publish a summary of results within 12 months of the end of the trial.
As co-Chair of the Make it Public campaign we have been campaigning for years for greater transparency in research, and this is a huge step forward for patients.
On the same day as the Clinical Trials regulations were laid before parliament, we also received the fantastic news that our work to replace and upgrade the system that researchers use to apply for the required approvals for research to go ahead passed the Government Digital Service’s (GDS) ‘alpha’ assessment.
We have been working hard in the background throughout 2024 to develop a replacement for the Integrated Research Approval System (IRAS). At the heart of our work has been involving IRAS users in the design of a system that makes it easy to submit research applications for review. This is a programme of work we have been talking about for many years; it is very exciting that it is now up and running and delivering.
The alpha assessment is a huge milestone in this process, and enables us to move onto the ‘private beta’ stage where we can start building more of the nuts and bolts of the system and begin testing.
We are investing heavily to deliver a world-leading approvals system within the next two years.
Priorities for our new strategy
Updating the Clinical Trials regulations and the systems used to apply for research approvals in the UK will be key focuses for the HRA in 2025, and will be front and centre in the development of our new strategy.
Our new strategy will build on the priorities outlined in the NHS 10 Year Plan, but also gives us an opportunity to work with the research community to find out what we can do as a regulator to continue making it easy to do research in the UK that people can trust.
It is an opportunity to set our expectations for research in the UK and support researchers to meet them so that more people are able and confident to choose to take part in research that is relevant to them.
In turn this will help embed research as part of healthcare, widen participation in research and improve care for everyone.
As with all government and NHS organisations there will be some tough decisions to make. Everyone is having to tighten their belts, and we are no different. It makes it more important than ever for us to be really clear on our priorities. I am grateful for the support of HRA staff and our partners in making and implementing difficult decisions. Our Community Committee will continue to be a vital part of our decision making throughout 2025 and I’m looking forward to working with them next year.
Wishing you a very merry Christmas
So, as we approach the end of another year, it’s important to acknowledge that the festive period can stir difficult feelings for some. Among the hustle and bustle of Christmas please do take a moment to soak it all in and appreciate the moments we share with our loved ones.
To everyone celebrating Christmas I wish you a restful festive period and hope that you get to spend some quality time with loved ones. From everyone at the Health Research Authority I’d like to wish you a very merry Christmas and a happy new year.
Chief ExecutiveMatt Westmore