By Liz Perraudin, Clinical Policy Manager, AMRC

Published: 22 November 2023

Today the Government has published its full response to Lord O’Shaughnessy’s review into commercial clinical trials. This follows an initial response when the review was first published in May, which we responded to.

Clinical trials provide patients with access to innovative treatments they would otherwise miss out on. They offer hope, particularly for those where no other treatment options are available, for example, with some rare diseases.

AMRC has been feeding into this response, including through our involvement in the Recovery, Resilience and Growth (RRG) programme and an engagement session we held for members with the Department for Health and Social Care (DHSC).

While Lord O’Shaughnessy’s review focused on commercial trials, its recommendations and the government’s response should have a positive impact on the whole research ecosystem. We particularly welcome the government’s commitment to maintain a balanced portfolio, including of early and late phase studies both in rare and common diseases.  

Today’s response also commits to introduce new national performance indicators for clinical trial activity, to develop a clinical research workforce plan, and to work with medical research charities to raise awareness of research. In addition, it provides an update on the five priority actions identified in May, including addressing the MHRA approvals backlog.

National Performance Indicators             

Lord O’Shaughnessy highlighted the importance of better metrics. In response, the government will introduce new system-wide UK Performance Indicators (UKPIs) which will be published monthly. Some of the UKPIs, like 80% of ‘open studies [being] on track, delivering to time and target’, apply to the whole clinical trial portfolio. Others, however, like 90% ‘of studies [being] open to recruitment within 60 days of HRA Approval letter’ are only being applied to commercial clinical trials.

The response also commits to aim towards the ‘doubling of recruitment by 2025, and then ensuring that firstly these levels are sustained, and secondly that we continue to aim for a further doubling by 2027’.  

We continue to be concerned that there is a potential risk of commercial trial activity being prioritised through these UKPIs, resulting in negative consequences for charity funded trials and a prioritisation of ‘easy-to-deliver’ trials over more complex ones.

It will be important to monitor the impact of these UKPIs on non-commercial clinical trial activity going forward. We are pleased the government’s response recognises the risks with this approach, commits to monitoring the impact and addressing any unintended consequences accordingly.  

These indicators will depend on having better data and better systems to keep track of the portfolio. The government’s monthly research status updates will continue as a new publicly available dashboard is developed and made available from Spring 2024. The government has confirmed it will continue support for the NIHR’s Clinical Research Network (which will become the Research Development Network in April 2024) work to produce real-time performance data on clinical trial activity.

Recruitment to research

Lord O’Shaughnessy’s review highlighted that clinical research is not well prioritised in the NHS and that the value of participating in clinical trials is not effectively communicated with patients.  

The review recommended an ongoing campaign, conducted in partnership with medical research charities, to promote the benefits of taking part in research. The response notes that DHSC and NIHR are working closely with us to explore how this campaign could work. We will be engaging with members to explore options before March 2024.

The government’s response also highlights that work is underway to explore how the NIHR Be Part of Research service could integrate with charity-run patient registries and research volunteer databases. AMRC will continue to support this work.

On wider opportunities to improve recruitment to research, the Health Research Authority (HRA) is exploring measures to streamline the process for approaching people about research participation opportunities, and new guidance is expected later this year.   

Workforce

Lord O’Shaughnessy’s review also highlighted challenges around the clinical research workforce.

We are pleased to see the government commit to the development of a clinical research workforce plan in today’s response.

Further commitments include NHSE working with partners to explore how to address challenges surrounding research workforce careers, the publication of a ‘multi-professional practice-based research capability framework’ for health professionals by Spring 2024, and an expansion of NIHR’s Development and Skills Enhancement award to anyone who has been awarded a PHD.

The government’s response also notes the need to support more research in primary care. It states that the new Research Delivery Networks (which will replace the NIHR CRN next year) will be developing capacity and capability for research in primary care.

Clinical Trial Accelerator Networks

Support for more innovative approaches to clinical trial delivery were also recommended in Lord O’Shaughnessy’s review, with proposals for Clinical Trial Accelerator Networks (CTANs).

Feedback from stakeholders, including AMRC members, was mixed, with many suggesting that any trial Accelerator should build on existing infrastructure.

The government has evolved the plans, and has instead announced two new Clinical Trial Delivery Accelerators (CTDAs). These will involve multidisciplinary teams of around 20 people, embedded within existing infrastructure, to focus on delivering studies in innovative ways. They are designed to test new more efficient delivery models, addressing common problems, with a view to learning what works and then scaling the approach in the wider research system.

The first CTDA will focus on dementia. It is a government priority through the dementia mission, has existing infrastructure around it like the Dementia Translational Research Collaboration Trials Network, and has a clear pipeline of both commercial and non-commercial trials.

The second CTDA will be the UK-wide Vaccines Innovation Pathway. It is already looking at innovative research delivery models, streamlining and accelerating them.

AMRC will closely monitor how these two CTDAs are working, and where there are opportunities to extend the approaches they use to other condition areas or across the system more broadly.

What next?

Today’s response to the Lord O’Shaughnessy review sets out an ambitious range of actions to improve the clinical trials and the wider clinical research landscape across the UK.

AMRC is an active member of the RRG programme, which will oversee the delivery of these commitments. We will continue to provide input into the programme’s work, making sure the plans laid out in today’s response are delivered on in a way that avoids unintended consequences for medical research charities and maintains the UK’s rich and balanced portfolio.