The O’Shaughnessy report: how to boost clinical trials in the UK 26 Jun 2023

The much anticipated O’Shaughnessy report examining commercial clinical trials in the UK was published at the end of May 2023. Its findings have prompted the UK government to initiate a series of actions, in response to its 27 recommendations, that are designed to make the UK a world leader in this important part of the life sciences industry.

In February 2023 the UK government commissioned an independent review to investigate the challenges facing commercial clinical trials and to offer recommendations to improve the clinical trial environment through growth and investment strategies.

The review was chaired by Lord James O’Shaughnessy, Senior Partner at consultancy firm Newmarket Strategy, Board Member of Health Data Research UK (HDR UK) and former Health Minister.

While the UK has been a preferred location for global clinical trials in the past, between 2017 and 2021 there was a 44% fall in the number of patients recruited to clinical trials, according to the Association of the British Pharmaceutical Industry (ABPI).

Lord O’Shaughnessy’s work builds on the government’s 10-year vision for clinical trials, ‘Saving and Improving Lives: The Future of UK Clinical Research Delivery’, which was published in March 2021.

The report outlines 27 recommendations, some to action in 2023 and others to undertake over the longer term, to secure the future of clinical trials in the UK. They result from feedback from a series of six workshops conducted with stakeholders, including industry leaders, medical research charities, academia, the NHS and regulators.

The recommendations address eight problem statements. The first four focus on set-up and approval processes, the lack of transparency and data about UK commercial clinical trials activity, a lack of accountability for underperformance in clinical trials, as well as how clinical research should be systemically prioritised by, or within, the NHS.

The other four point out: a lack of incentives for doctors, nurses and NHS organisations to take part in clinical research, especially that which is commercially funded; few conversations between doctors and patients about clinical research, especially for marginalised and disadvantaged communities; a failure to use the NHS’s considerable data assets, and finally, despite the opportunities clinical research provides for delivering population-scale trials, UK primary care is a negligible provider of clinical trial activity.

The O’Shaughnessy review recommends a mix of regulatory, funding and policy actions to reinvigorate trial activity and create a favourable environment for innovative clinical trials.

In response to the report, at the end of May 2023, the government confirmed it would commit up to £121m to five undertakings initially. These are:

• Substantially reduce the time taken for approval of commercial clinical trials, with the goal of reaching a 60-day turnaround time for all approvals

 This step will be led by the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) and backed by £3m Department of Health and Social Care (DHSC) funding over three years. This is in conjunction with the 2023 Budget announcement to provide £10m over the next two years to MHRA to help bring innovative new medicines and medical technologies to UK patients more quickly.

The MHRA is working with industry trade associations to reduce the backlog of delayed applications and is committed to making regulatory decisions within statutory timeframes.

• Deliver a comprehensive and mandatory national approach to contracting

The review recommends building on the existing National Contract Value Review (NCVR), which was set up through the Future of Clinical Research Delivery: 2021 to 2022 implementation plan.

The government reinforced its commitment to a mandatory national approach to costing and contracting, led by NHS England, pledging to deliver an enhanced service from October 2023. This new approach will allow ‘organisations to agree contract values once with a lead site on behalf of the whole NHS; a site-specific multiplier will ensure full cost recovery for all trusts and increased transparency for industry; and an unmodifiable financial appendix will be added to the existing suite of nationally mandated contracts, developed and agreed with the sector’.

In addition, it may be possible to broaden the scope of NCVR to include early phase studies and advanced therapy medicinal products (ATMPs) from October. A working group will agree and implement national commercial clinical trials contracting documents and technical review processes, backed by an additional £15.75m over three years from NIHR.

• Provide ‘real-time’ data on commercial clinical activity in the UK

NIHR currently collects and manages clinical research performance data. In addition, the NHS-NIHR’s Be Part of Research platform helps the public, patients and clinicians find out about health and social care research across the UK, including commercial trials.

However, the government acknowledges that these arrangements can be enhanced to improve transparent and easy access to data and information, with delivery to begin immediately, backed by £81m over three years, provided by the NIHR.

• Establish a common approach to contacting patients about research

The Health Research Authority (HRA) will work closely with its Confidentiality Advisory Group, the National Data Guardian, the Information Commissioner’s Office, DHSC and NHS England to streamline the processes to approach patients about research.

This group will decide how the public should be consulted and identify whether legislation is needed to establish clinical research as part of direct care, making it easier to provide innovative treatments to patients. This will be supported by funding of up to £1m.

• Establish clinical trial acceleration networks

The review notes that regaining the UK’s global leadership position requires restoring more ‘traditional’ clinical trial activities, but also recommends accelerating new and innovative ways to deliver trials.

A total of £20m over two years will be provided to establish two or three clinical trial acceleration networks (CTANs), probably for infectious disease vaccines, cancer and dementia.

These networks will support emerging place-based knowledge clusters to ensure that research delivery is spread both nationally and locally. They will be held up as examples of best practice for the development and spread of new approaches.

As recommended by the review, the UK Clinical Research Recovery, Resilience and Growth (RRG) Programme will develop SMART objectives for commercial clinical research and report these regularly to the Life Sciences Council. A full implementation update on this progress will be published in autumn 2023.

While the UK fell from fourth in 2017 to tenth in 2021 in the global rankings for phase 3 industry clinical trials – partly as a result of growing international competition, plus a necessary focus on COVID-19 research – the O’Shaughnessy report highlights several examples where innovative therapies have successfully completed trials and made a difference to patients.

Lord O’Shaughnessy charges the government with the aim of doubling the numbers of people taking part in commercial clinical trials in the next two years, then doubling it again by 2027. This, and the five undertakings the government has committed to, could see the UK regain its position as a world leader in this area.

If you would like advice on the fast-changing commercial clinical trial situation in the UK, PharmaMedic Consultancy has a proven track record of assisting companies in this area. Our network of specialist consultants is standing by to guide you through all aspects of bringing a therapy or device to market.  Please contact us now on: Tel: +44 (0) 208 168 1668 or Email: hello@pharmamedic.co