Clinical research delivery partners and the Government’s full response to Lord O’Shaughnessy’s independent review 

The thoughtful and considered input from all of the partners makes this response a truly collaborative effort with the cross-sector agreement to deliver the following over the next two years:

• Fully implement the five headline commitments announced in May 2023;

• 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.

The partners were pleased with the approach of the response, building upon the strong foundation that is our clinical research ecosystem – integrating the recommendations made by Lord O’Shaughnessy into the existing Future for UK Clinical Research Delivery strategy – a familiar framework for all of the delivery partners. The response updates and supersedes our previous plans and provides renewed focus to ensure we make the progress necessary to ensure we are a global leader in the delivery of life sciences research while also ensuring continued progress towards Department of Health and Social Care’s (DHSC) ten-year Vision.

All of the partners have made great progress over the last year to improve the health and performance of the UK’s clinical research system, including. 

• The Medicines and Healthcare products Regulatory Agency (MHRA) assessed over 2,000 clinical trial initial applications and amendments. 

• From September 2023, all valid initial applications have received combined regulatory review, MHRA/research ethics committee (REC), within 60 days.

• Recruitment to commercial contract research is now an average of over 5,000 people a month in comparison to a pre-pandemic average of 3,200.

• Over 80% of commercial contract studies are on track, as validated by sponsors

• The set-up of new commercial studies has been reduced by over 100 days. (36%) since a new approach was implemented in October 2022. 

• We have delivered on our commitment to implement site specific multipliers for NHS trusts in England and a new unmodifiable financial appendix to our suite of UK-wide model contracts.  

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 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."

Emma Lowe, Head of Clinical Research Delivery and the Clinical Research Recovery Resilience and Growth Programme Lead, DHSC, said:

“Since 2021, we’ve seen the UK’s clinical research organisations work hard to progress our ambitious vision for the future and get the country's clinical research system back on track post-pandemic.” 

“Those efforts are now paying off with more commercial studies open for delivery than before the pandemic and over 80% of them delivering to time and target. High levels of performance are also being maintained across the non-commercial portfolio, demonstrating that we can grow our commercial portfolio while also maintaining our great strengths in delivering studies funded by medical research charities and other non-commercial funders.”

“There’s more work to be done, but I’m confident that with the progress we have seen already and Lord O’Shaughnessy’s review propelling the vision forward, the UK will be one of the best places to conduct clinical research.”

All of us recognise that the health needs of the UK and our research system are broad and diverse. We are committed to maintaining a rich and balanced portfolio – early and late phase, commercial and non-commercial with a range of methodologies and sizes.The publication provides a clear signal to the health research system that the government remains committed to making the UK a world leader in conducting clinical research of all types.

Quotes

Professor Lucy Chappell, DHSC’s Chief Scientific Advisor and Chief Executive Officer for the National Institute for Health and Care Research 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.”

Michael Matheson, Health Secretary Scotland, said: 

“We welcome Lord O’Shaughnessy’s review of commercial clinical trials which sets out clear areas for improvement across the whole clinical research pathway.

“Through our Chief Scientist Office, we continue to work closely with our partners across the UK to drive forward a more innovative, efficient, and inclusive clinical research system. This work is vital to the recovery and reform of the health service to deliver benefits to our patients, NHS Scotland and the economy.”

Professor Ian Young, Chief Scientific Advisor, Department of Health Northern Ireland, said:

“In Northern Ireland, we are committed to delivering on a UK-wide vision within Health and Social Care Research & Development. Working with partners, we are progressing both UK-wide and local actions to support the recommendations, helping NI to continue to grow clinical research, which is ultimately benefitting our patients, researchers and the wider population.”

Minister for Health and Social Services Wales, Eluned Morgan, said:

“Clinical research is vital as it ensures people have access to innovative studies which help to deliver better treatment and care for all.

“The latest plan, which takes into account recommendations from the Lord O’Shaughnessy review sets out tangible actions, and by working with our UK partners, Wales is keen to play its part in increasing the UK’s attractiveness as a destination for life-changing research.”

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.”

Nicola Perrin MBE, CEO of 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.”

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.”

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.”

Janet Valentine, Executive Director of Innovation and Research Policy for ABPI, said: 

"The ABPI has long called for a delivery-focussed approach to getting UK industry clinical trials back on track, and today the Government has delivered a clear plan that will make a real difference to patients.

“We’ve got a long way to go if we want to see sustained recovery, and achieve the ambition set out in Lord O’Shaughnessy’s review to quadruple recruitment to industry clinical trials. But by continuing to streamline approvals and set-up, and expanding dedicated capacity, we now have a clear strategy to rebuild global confidence in the UK’s clinical research offer.

“In an environment where there is ever-growing international competition for industry investment in research, today’s response is very welcome, and we will continue to play our part in putting it into action so that more patients can participate in trials and benefit from innovative therapies.”