By Nisha Tailor, AMRC Director of External Affairs

Published: 25 May 2023

Today Lord O’Shaughnessy has published his Independent Review of the commercial clinical trials in the UK, together with the government ‘s response. We have welcomed his review and its wide-ranging recommendations, alongside the government’s announcement of funding and commitment to take some immediate actions.   

AMRC were pleased to share the sector’s views through workshops and discussions as Lord O’Shaughnessy developed the review. Below are our reactions to some of the key recommendations and the government’s response.  

Making the system work better, faster and smarter  

Lord O’Shaughnessy’s assessment is that clinical trials approvals and set up are slow and bureaucratic. Our members and partners agree, the current regulatory and set up delays make the UK a less attractive place to do research and leave patients anxiously waiting to participate in clinical trials. We therefore welcome the recommendation in the review, and the government’s immediate action, to set up a MHRA task and finish group with the goal of achieving a 60-day approval turnaround.  

Funding announced to establish 2-3 clinical trials accelerator networks (CTANs), £20 million over 2 years, could also help re-establish the UK as a world-leader. The initial CTANs are expected to focus on infectious disease vaccines, cancer, and dementia. 

The Government has also prioritised the need to provide real-time data on clinical activity, as recommended in the review.  A new system to collect near real-time data and a UK trial directory, as part of Be Part of Research, will be welcome and hugely valuable to all involved, including patients, medical research charities, industry and the NHS. Having a better understanding of the UK’s whole trial portfolio will help understand where there are challenges and what action is needed. 

But we do urge one note of caution. The O’Shaughnessy review proposes the use of targets solely focused on commercial clinical trials. The strength of the UK’s life sciences lies in its diversity of funders; it is our expertise and competitive edge in early phase trials and academic clinical research that helps to attracts commercial clinical trials to the country. When implementing these recommendations, care must be taken not to destabilise the UK’s diverse clinical ecosystem. 

Public and patient awareness of clinical trials  

The review points out that conversations about research with patients in the NHS are largely absent and that awareness of research amongst the public is low. To address this, it proposes an ongoing public campaign to promote research in partnership with medical and research charities and the integration of ‘research conversations’ into all NHS communications and clinical interactions. 

AMRC supports a public campaign and ‘research conversations’, with charities as key partners.  Medical research charities are trusted organisations with strong connections to their patient communities and underserved groups, they can play a vital role in raising awareness of research. We were pleased to note that the review highlighted AMRC's work on sharing best practice on patient and public involvement.  

Maximising data for research 

The O’Shaughnessy’s review also notes that the NHS is failing to take advantage of its data assets and that we need a better approach to consent and contacting people about research. We fully endorse this view. We want to see urgent reform to drive responsible access to data. This must be done with clear communication and sustained, meaningful public and patient engagement – but this should not be an excuse for inaction.  

The challenge of contacting patients about research and consent needs to be addressed. The government is considering a consultation to update legislation to make clinical research part of direct care. This is potentially an exciting way to ensure all patients can benefit from the opportunities of taking part in clinical trials and we look forward to seeing further details. 

Leadership and workforce to embed research in the NHS  

Lord O’Shaughnessy rightly identifies that research is a missed opportunity and more needs to be done to embed research in the NHS. Recommendations include leadership from the NHS and Ministers, annual R&D targets for the NHS, and R&D leads in integrated care systems. We welcome this direction of travel. For too long, research in the NHS has lacked the leadership it needs. 

Recent reports by Academy of Medical Sciences and Cancer Research UK identified that NHS staff find it difficult to undertake research, due to time, funding and other organisational challenges. And the review proposes the inclusion of clinical trials career path in the NHS Long Term Workforce Plan. But we would want to go further with the recommendation that the NHS Workforce Plan includes research capabilities as a strategic priority, ensuring that all NHS staff have awareness of research, alongside training and capacity to do research, if they wish to. The government has yet to respond on workforce.   

The review also highlights the potential for primary care to play a role in delivering clinical trials. This is an area that is often overlooked, and the proposed financial incentives for GPs should help drive change.  

Next steps  

In addition to the immediate actions, the government has committed to an update on implementation progress, together with a comprehensive response to the review in the autumn.  

We will continue to engage with government and others as an implementation plan is developed.  For example, we are already working with NHS England to explore how charities can help with patient recruitment to clinical trials.  

To sum up, the O’Shaughnessy review offers an opportunity to transform clinical trials in the UK and ensure we remain a world-leading destination for clinical trials to give patients better access to both new research and innovative treatments.