The government has published its full response to Lord O’Shaughnessy’s independent review into commercial clinical trials in the UK.
The response outlines plans to make the UK one of the best places in the world to conduct clinical trials by implementing all of the recommendations made by Lord O’Shaughnessy.
It follows an announcement in May this year to speed up clinical trials and make it easier for revolutionary healthcare treatments to get to NHS patients, which was backed by £121 million in government funding.
The full government response is available here.
In a joint foreword with the UK health secretaries, Health and Social Care Secretary Victoria Atkins wrote:
“The actions we are taking now to address the recommendations of the review will provide benefits for patients and the NHS across the UK; improve the environment for all types of clinical research; and drive forward improvements urgently to maintain our place as one of the most attractive places in the world to conduct industry clinical trials.
“Our actions are supporting our fantastic life sciences sector, bringing investments into the UK and helping to build the economy. By delivering improvements across the whole clinical research pathway from early translation to late phase trials, we will ensure more people have access to innovative clinical trials that are relevant to them, and ultimately deliver better prevention, treatment, and care for all.”
What was the aim of the independent review?
The government appointed Lord James O’Shaughnessy, former health minister, in February 2023 to carry out an independent review into UK commercial clinical trials.
He made 27 recommendations where action should be taken by the government and delivery partners - NHS England, Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the National Institute for Health and Care Research (NIHR) - to address key challenges and transform the commercial clinical trials environment.
We are implementing his recommendations in full.
What are the main recommendations you are implementing?
Over the next two years the government will fully implement the five headline commitments announced in May 2023. These include:
- Substantially reducing the time taken for approval of commercial clinical trials, with the goal of reaching a 60-day turnaround time for all approvals, brining innovative new medicines and medical technologies to UK patients more quickly.
- Deliver a comprehensive and mandatory national approach to contracting to get studies up and running more quickly to deliver patient benefit faster.
- Provide ‘real-time’ data on commercial clinical activity in the UK to benefit all NIHR Clinical Research Network portfolio research from all funding sources, and ensure that transparency and accessibility for patients, clinicians and research funders is enhanced.
- Establish a common approach to contacting patients about research and achieving greater data usage for research delivery in a way that commands public trust.
- Establish clinical trial accelerator networks (CTANs) to support emerging place-based knowledge clusters to ensure that research delivery is spread both nationally and at a local level.
The government is also committed to:
- Make progress in tackling all the problem statements identified by Lord O’Shaughnessy;
- Continue work to improve the operating environment for all types of clinical research using National Performance Indicators and being transparent about the latest status of these metrics;
- Increase adoption of more innovative, decentralised models of clinical trial delivery through Clinical Trial Delivery Accelerators in vaccines and dementia.
What progress has been made since the review was published?
Since the publication of the review in May 2023, we have made strong progress in strengthening the clinical research system, including:
- We are already meeting our goal of reducing approval times within 60 days. The MHRA assessed over 2,000 clinical trial initial applications and amendments between July to October, with all studies receiving regulatory approval within 60 days.
- Recruitment to commercial contract research is now an average of over 5,000 participants a month in 2023, in comparison to a pre-pandemic average of 3,200.
- 82% of commercial studies are on track.
- In October, it was announced that set-up of new commercial studies has been reduced by over 100 days (36%).
Are you supporting this with new funding?
In May, we outlined the following funding commitments:
- £81 million through NIHR to improve the transparency and accessibility of clinical trial data. This will make it easier for patients and the public to take part in clinical trials by providing ‘real-time’ information about ongoing research across the county and improve the ability of organisations with oversight for research to keep studies on track and intervene quickly if problems occur.
- £15.75 million through NIHR to implement national contracting processes for commercial clinical trials to address delays in the set-up of studies taking place across multiple NHS organisations.
- £3 million for the HRA to support ongoing work to speed up the approval of clinical trials, helping to bring new medicines and medical technologies to NHS patients more quickly, with the goal of approving all clinical trials within 60 days. This is on top of £10 million recently announced for the MHRA to develop an agile approval process for cutting-edge medicines.
- £20 million to establish two or three Clinical Trial Acceleration Networks, which will bring together several existing mechanisms to create a joined-up approach to clinical trials across the country, focusing on accelerating priority areas of research and delivering best practice.
- Up to £1 million to explore how we best set up a shared approach to contacting patients and the public about research.
This £121 million will be funded by £20 million of new funding and £101 million from reprioritised DHSC budgets (NIHR).
How will clinical trials benefit patients and the NHS?
Clinical research is the single most important way in which we improve our healthcare – by identifying the best way to prevent, diagnose and treat conditions.
Evidence shows hospitals which undertake research have better patient care outcomes, improved staff retention and it benefits the whole health and care system. Clinical trials are part of the solution for reducing the strain on the NHS.
How do commercial clinical trials work?
Commercial clinical trials are fully funded by the companies developing new treatments and products and provide the NHS and patients with earlier access to innovation. The commitments we are announcing will make it quicker and easier for companies to trial more of their products in the NHS.
How can I sign up to research?
Anyone can take part in research whether you have a health condition or not. Over 370,000 have already signed up to Be Part of Research this year alone. You can also take part in research at a local hospital, GP practice – or even at home.
It's easy to get involved. Visit here and simply sign up online. You can choose the health conditions you are interested in. You will be sent details of approved studies that match your interests to decide if you want to take part.
Professor Lucy Chappell, DHSC’s Chief Scientific Advisor, said:
“This programme of work sets out to provide benefit to patients and the public through improved access to clinical trials. The health needs of the UK and our research system are broad and diverse. We are committed to maintaining a rich and balanced research portfolio – early and late phase, commercial and non-commercial trials of varying sizes and with a range of methodologies. This will complement the strong scientific excellence across the UK, and the track record of our system in delivering research that has impact.”
Vin Diwakar, Interim National Director of Transformation, NHS England, said:
“We welcome the recommendations in Lord O’Shaughnessy’s Review and are working with the government to ensure the NHS remains a world leader in health research.
“In the last year we’ve made it quicker than ever to set up clinical trials in the UK through the National Contract Value Review policy. Our Workforce Plan recognised the importance of research and we’ve committed to work with the NHS and partners to better support and encourage research workforce careers.
“The development of the world’s first effective treatment for Covid-19 by securely using NHS data shows the vital role research plays in saving lives, and we’re committed to helping more people, and more diverse groups of people, get involved in research.
“Our NHS DigiTrials service has helped recruit over 1 million people to large-scale, vital studies, and many more have volunteered to take part in research via the NHS App.
“I’m delighted to see the number of studies and people taking part in them exceeding pre-pandemic levels, so that the research we carry out today can help save lives in the future.”
Lord James O’Shaughnessy said:
“There have been a number of positive changes since my report was launched. The MHRA is performing much better, there is significant progress towards a national approach to contracting and costing, and most importantly the number of – and patients recruited to – industry-sponsored trials in the UK is growing again.
“There is still much to do, so I’m pleased to see a renewed commitment to delivering my recommendations and achieving the ‘double-doubling’ of commercial trials by 2027. This will be an essential part of supporting the life sciences ecosystem and making the UK one of the best places to deliver clinical research."
Dr June Raine, MHRA Chief Executive said:
“We fully support the ambition for the UK to be one of the most attractive places in the world to conduct clinical trials and our total overhaul of the clinical trial regulations will help achieve this.
“As the government response has highlighted, we have already made significant progress. We’re moving away from a one-size-fits all regulatory approach to a more flexible and risk-proportionate one, such as that underpinning our new notification scheme for the lowest-risk trials, that will see up to 20% of trials up and running quicker.
“We are confident that our changes will cement the UK as a destination for trials that is innovative, inclusive and international, and will most importantly help get life-changing medicines to the people who need them sooner.”
Nicola Perrin MBE, CEO of AMRC (the Association of Medical Research Charities) said:
“Time matters when you need treatment. Delivering on the vision for clinical research is essential to speed up innovation for all trials including those led by charities. We are eager to take up the opportunity to work with Government and NIHR to raise awareness of the opportunity to participate in research – particularly to ensure that all communities can be reached.”
Darius Hughes, UK General Manager for Moderna, said:
“We welcome the progress made since the report’s publication, particularly on regulatory approval timelines and the introduction of a national mandatory costing approach. The restatement of the ambition to grow clinical trial activity in UK by 2027 to double that of the pre-pandemic baseline also provides an important boost to UK life sciences.
“The commitment to increase transparency of UK clinical trial performance through a new suite of performance indicators and deliver large scale trials that recruit from diverse populations are also important deliverables that will widen access to research.
“Through Moderna’s significant investment into clinical trials in the UK, we look forward to supporting the full implementation of the report. As well as bringing benefits to UK patients through increased opportunities to access commercial clinical trials, this will help reinvigorate the UK’s world class reputation in clinical research.”