In May 2023, former health minister Lord James O’Shaughnessy acknowledged in a report that there were many issues with the UK’s clinical trial industry. The report showed that the country fell from fourth to tenth globally for trial initiation, with a big drop in the number of Phase III trials initiated.

At the same time, the UK’s National Health Service (NHS) has been under extreme pressure with staffing woes, including the recent junior doctor strikes and financial difficulties impeding clinicians' ability to participate in research, especially in more demanding cell and gene therapy trials.

With a snap general election now looming on 4 July and the NHS being one of the top concerns for voters, it is more important than ever for political parties to set out their manifesto including how they are going to facilitate research and support the NHS.

The UK Conservative government has tried to improve the country’s ability to develop cell and gene therapies, with a $10m grant in March 2023 for the NHS Blood and Transplant (NHSBT) to open a facility to develop and manufacture new gene and cell therapies called the Clinical Biotechnology Centre (CBC).

Funds have also been provided to several companies through the Life Sciences Innovative Manufacturing Fund (LSIMF) grants, including £151m for Pharmaron and £14m for Touchlight for cell and gene therapy development and manufacturing.

On top of all this, the UK’s National Institute for Health and Care Research (NIHR) has announced a £17.9m investment in the Advanced Therapy Treatment Centre Network (ATTC Network).

A year on from Lord O’Shaughnessy’s report and despite the governments investment in the industry, the UK is still struggling to contribute to cell and gene therapy trials says haematologist and chief medical officer of stem cell charity Anthony Nolan Dr Robert Danby. Danby speaks exclusively to the Clinical Trials Arena about the difficulties facing the NHS in contributing to cell and gene therapy research.

Abigail Beaney (AB): Following Lord O’Shaughnessy’s report, have you seen any changes in the clinical trial industry in the UK?

Robert Danby (RD): The UK Government has committed to implementing all of Lord O'Shaughnessy's recommendations, and we have seen some progress in the year since. Average trial approval and set-up times have been reduced. The number of people taking part in industry clinical studies is rising. According to the Department of Health and Social Care, 82% of commercial studies are on track.

Despite this, there is still more work to do. A thriving clinical research environment depends on an NHS that has the resources and workforce to support it – with trials relying on the UK’s network of clinicians, nurses, allied health professionals, statisticians, data managers, and more.

But as organisations such as Cancer Research UK have pointed out, we’re still a long way from NHS staff having the capacity to prioritise research. A survey of health care professionals revealed nearly four in five clinical researchers described lack of capacity as a substantial or extreme barrier to their work. It means clinical research is at risk of being seen as a nice-to-have, rather than an essential mechanism for bringing new and potentially life-saving therapies to the UK.

The O’Shaughnessy review said less about tackling the barriers patients face to getting onto a clinical trial. We need to think more ambitiously about the diversity of trial participants, to ensure no groups miss out on the potential improvements to care they offer. We also need to see investment in the real-world data landscape that can play such a pivotal role in advanced cell and gene therapies research.

AB: Given the resources needed for cell and gene therapies, does the NHS have enough resources and funding to be able to assist in the development of these kinds of drugs?

RD: While we have seen commercial trial capacity increase in the last year, cell and gene therapies present additional research challenges that require a concerted effort to overcome. As a haematologist and in my work at Anthony Nolan, I see this close up.

Blood cancers and other haematological disorders are at the forefront of the oncoming wave of new cell and gene therapies. With over 50 years’ experience in cell therapies, both allogeneic and autologous haematopoietic cell transplantation, haematology is one of the few medical fields with the necessary skills and expertise to deliver clinical research into these potentially transformative treatments.

But the UK’s haematology departments are not yet equipped, or resourced, to deliver this next wave. For example, cell and gene therapies are reliant on apheresis technology to collect the cells which form the basis of new engineered treatments. But current infrastructure is struggling to cope with basic clinical needs for standard indications, never mind additional requirements for therapy development.

Challenges to recruit to cell and gene therapy trials and rigorous regulatory pathways also contribute to the strain faced by NHS teams expected to deliver both basic care and clinical research. And as cell and gene therapy trials move into other areas of medicine like solid cancers or autoimmune diseases, there will need to be a massive increase in resources, training, and education across the breadth of the NHS.

In order to sustain the development of future cell and gene therapies, long-term investment into NHS capacity, education and training is essential. A more streamlined journey from research to regulatory approval and implementation, that is appropriate for the specific requirements of cell and gene therapies, is also needed.

AB: Following Brexit, how important is it for the UK to remain a top science hub and how is the lack of resources impacting this?

RD: Brexit has compounded many of the issues affecting the UK’s position in the global clinical research market. In my field of haematology, the well-recorded loss of NHS and academic staff due to Brexit has had major implications on our ability to carry out not only day-to-day care but also clinical research.

We’ve also heard that differences in the regulatory framework and bodies between the UK and Europe post-Brexit have made the industry reluctant to start trials in the UK because implementation into routine care use looks too time-consuming and challenging.

AB: Tell us about the Accelerating Clinical Trials (ACT) model and how it can support the UK clinical trial industry.

RD: Accelerating Clinical Trials (ACT) is an innovative self-sustaining model to facilitate the delivery of clinical trials for blood cancers and blood disorders.

The ACT operational hub provides services to industry-sponsored commercial trials – including access to a national network of recruitment sites, clinical research expertise and operational support – and reinvests the income into non-profit academic investigator-led trials.

The O’Shaughnessy review highlighted that in its first 12 months, ACT attracted investment from two international pharmaceutical companies to deliver practice-informing blood cancer trials. With the income, ACT works with two major national trial acceleration networks which have recruited more than 2,500 patients in recent years, to the benefit of both patients and the UK life sciences sector.

Earlier this year, Anthony Nolan announced its £1m investment into the programme.

AB: What more support does the industry need so it can be at the forefront of pivotal drug development such as cell and gene therapies?

RD: We recognise we are seeing a revolution in cell and gene therapies, and the opportunity in the UK is huge. Our nationalised health care system, with strong links to academia, and healthcare data mean there is enormous potential for UK patients to be some of the first to benefit from these innovative and potentially curative therapies. But only if we act now to address issues in NHS capacity, invest in world-leading data systems and simplify the pathway to therapy implementation.