Statement on Lord O’Shaughnessy Review into Commercial Clinical Trials

Statement on Lord O’Shaughnessy Review into Commercial Clinical Trials

Statement by: Andrew Stephenson

The UK demonstrated its strength in clinical research during the pandemic through the rapid design and set up of studies. Over 2 million people participated in COVID-19 trials of treatments and vaccines across the UK.

The collaboration that arose between researchers, the Government, the life sciences sector and the NHS drove one of the greatest joint missions in history – something that no other country or international organisation was able to deliver at the pace and scale that we did.

Despite this remarkable success, data published by the Association of the British Pharmaceutical Industry (ABPI) in October 2022 highlighted a decline in the number of commercial contract clinical trials initiated in the UK, primarily in 2020 and 2021. This was due to the challenge of the pandemic as many studies were paused to allow the system to focus on nationally prioritised COVID-19 studies. This change was needed to address the urgent need to identify treatments.

While the collaboration seen during the pandemic showed the agility and resilience of the clinical trial sector in the UK, the Government has recognised that more work needed to be done to sustain and grow this momentum, and to build and strengthen the sector. The Government’s vision is to unleash the full potential of UK clinical research delivery to help address health inequalities, bolster economic growth and improve the lives of people right across the UK. Clinical research delivery partners across the UK have been working on a coordinated plan to transform delivery of clinical research in the UK since 2021, as set out Saving and Improving Lives: the Future of UK Clinical Research Delivery(opens in a new tab).

In February 2023, the Government commissioned Lord O’Shaughnessy to conduct an independent review to offer recommendations on how to resolve key challenges in conducting commercial clinical trials in the UK and improve the UK commercial clinical trial environment.

In May 2023 Lord O’Shaughnessy’s review into commercial clinical trials was published. The review set out 27 recommendations, including priority actions to progress in 2023 and longer-term ambitions for UK commercial clinical trials. The review acknowledged the improvements already made and underway and highlighted areas where the system could go faster and further.

Alongside the publication of the review, the Government published an interim response to the review where the Government made five headline commitments backed by up to £121 million.

The five headline commitments were:

1. To substantially reduce the time taken for approval of commercial clinical trials, with a goal of reaching a 60-day turnaround for all approvals
2. To deliver a comprehensive and mandatory national approach to contracting
3. To provide ‘real-time’ data on commercial clinical activity in the UK
4. To establish a common approach to contacting patients about research; and
5. To establish clinical trial acceleration networks (CTANs)

In addition to these commitments, the Government also accepted in principle the foundational action to develop SMART objectives for all of the ambitions in the vision for clinical research delivery, with owners held to account for delivery by the Life Sciences Council.

Since the publication of the review and the initial Government response we have made excellent progress. For example, in September 2023 the MHRA met the target of all studies receiving regulatory approval within 60-days. This is a significant achievement, providing much needed predictability and stability for study sponsors and funders.

Furthermore, recruitment to commercial contract research is now an average of over 5,000 a month in comparison to a pre-pandemic average of 3,200, 82% of commercial studies are on track, and set-up of new commercial studies has been reduced by over 100 days (36%) since our new approach was implemented in October 2022.

Collaborative research funded by both the life sciences industry and non-commercial funders such as medical research charities has also recovered to match our pre-pandemic baseline of over 6,900 people recruited on average each month.

Building on this success, I am pleased today to announce to the House the publication of the Government’s full response to Lord O’Shaughnessy’s review, coinciding with the quarterly meeting of the Life Sciences Council. We have accepted all of the problem statements and the majority of the report’s recommendations. In some places we have proposed alternative ways to deliver the ambition behind the recommendation.

This response sets out a full system-wide response with cross-sector input outlining that over the next two years delivery partners will:

• 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 response builds 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 framework, to make the UK one of the best places in the world to conduct 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 portfolio – early and late phase, commercial and non-commercial with a range of methodologies and sizes.

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 our ten-year Vision.

Implementation of the response will begin immediately, with quarterly updates and monthly cross-sector communications being made publicly available on The Future of UK Clinical Research Delivery microsite.

The publication today provides a clear signal to the health research system that this Government remains committed to making the UK a world leader in conducting clinical research of all types.

Copies of the Government’s response have been deposited in the Libraries of both Houses.