Refreshing clinical trials activity must benefit people with blood cancer

In June 2023, we shared this blog about how Lord O'Shaughnessy's recommendations had the potential to reinvigorate the sector and help us beat blood cancer. In this article we explore the progress so far, new commitments made and areas where we’d like to see further initiative taken.

Health is a devolved issue, meaning that decisions are taken locally in Scotland, Wales and Northern Ireland, but we're pleased to see that the health ministers for all UK nations have come together to sign this response and commit to delivering change across the UK.

It's essential that improvements to the commercial clinical trial sector in the UK benefit people with blood cancer, wherever they live.

We welcome the news that the Medicines and Healthcare products Regulatory Agency (MHRA), responsible for making sure medicines work and are safe, has made progress in clearing its backlog, with over 2,000 clinical trials applications processed between July and September 2023. More work is needed here to make sure that all trial applications are processed on time. We also welcome the commitment to establishing a common approach to recruiting patients to research before the end of this year. Clinical trials are important for people with blood cancer, and so making sure everyone has a chance to get involved in research if they want to is vital to bring us closer to the day no one dies of blood cancer.

The Government response includes encouraging commitments to recover and expand the UK’s clinical research workforce. These include:

• In England, putting a workforce plan in place to support clinical research delivery
• In Wales, creating a nurses and allied health professionals (AHP) research action plan to ensure that nurses and AHPs are central to helping Wales achieve it’s clinical research delivery goals
• In Northern Ireland, creating an AHP Research and Innovation Strategy. This strategy was published this week and sets out how AHPs will support Northern Ireland’s research and innovation agenda by addressing challenges in capacity, capability, context and culture.

These are all expected to motivate and increase capacity and sustainability of the clinical research workforce. However, we'd like to see progress in this area fast tracked and incentives introduced to encourage former members of the clinical research workforce to resume research activities.

In our last blog, we shared our excitement about the recommendation to establish Clinical Trial Acceleration Networks to enable government and the NHS to develop the key steps of clinical trials by subject, such as cancer, in order to speed up the process and give people access to new drugs, faster.

The government response shares that it has been difficult to reach consensus on the best way to approach these networks. We welcome the commitment to embed networks in existing research infrastructure – many excellent practices already exist, so we need creative ways to connect, implement and scale them up across the UK. Only the first of these networks has been announced, focused on dementia. The response sets out that many of the key elements to the proposed accelerators are exemplified in existing processes for vaccine development, which includes the development of cancer therapeutics. While this is an important acknowledgment, we hope a dedicated Clinical Trial Delivery Accelerator for cancer is still in the pipeline.

We look forward to monitoring trial development in the UK, although we're sceptical about the emphasis that has been placed on contracting and delivering new monitoring tools and how it might impact smaller sites who may not have the capacity to do this. We want to see more trials delivered locally so that more people can take part in research, whether that be because they live rurally, far away from a large teaching hospital, or because they are too unwell or can’t afford to travel long distances.

Blood cancer is complex by nature and so trials for new treatments are complex too. Smaller research sites may not be able to move at the same speed as larger ones and it’s also true that trials for children or older, more frail populations, including people with blood cancer, are more difficult to set up, meaning these trials are limited to centres that have the time and resources to push them through. We echo the Association of Medical Research Charities’ concerns that the new monitoring tools risk prioritising ‘easy-to-deliver’ trials over more complex ones and may restrict where these trials can take place.

We would also welcome a stronger effort to monitor the diversity of research participants. The National Institute of Health Research (NIHR) INCLUDE project provides a framework to improve inclusion of under-served groups in health and care research. We would like to see this guidance rolled out more widely across the UK as part of the efforts to increase the diversity of research participants in clinical trials.

Finally, we welcome the confirmation that ‘all patients receiving genomic sequencing of any kind in the UK should be offered a standard consent for engaging in research.’ Genomic sequencing is a laboratory procedure to understand the order of an individual’s DNA building blocks and can identify changes related to cancer. Some people with blood cancer are automatically eligible for genomic sequencing after diagnosis, so commitments in this area could be transformative to the number of people with blood cancer involved in research, such as via studies developing personalised cancer treatments.

We’re looking forward to the many initiatives set out by the Government response and will be working across all four nations to monitor progress and champion the voices of people with blood cancer.

In summer 2024, we’ll be launching our Blood Cancer Action Plan, a landmark policy report developed by people affected by blood cancer and experts in the field. The report will work to understand where differences in care, including access to clinical trials and new treatments, affect survival and make recommendations on how survival from blood cancer in the UK can be improved.

Our Clinical Trials Support Service continues to provide information, advocate for and offer impartial advice to people with blood cancer and their loved ones about trials they are enrolled in or might be eligible for. The service, started in 2020, has already conducted searches for over 200 different people, logging over 300 different clinical trials.

In Wales, we represent the Blood Cancer Alliance on the Wales Cancer Alliance’s sub-group on cancer clinical trials where we’re developing a joint position on cancer clinical trials. On 14 December 2023, Dr Ceri Bygrave, Consultant Haematologist and myeloma lead at University Hospital of Wales in Cardiff, spoke to Members of the Senedd, the Welsh Parliament, at the Cross Party Group on Cancer’s session on clinical trials. As well as discussing the challenges and opportunities for the clinical research sector in Wales, Dr Bygrave presented examples of how clinical trials can improve and extend the lives of people with blood cancer. Dr Bygrave continues to champion efforts in this area in her role as Chair of our Access to Treatments working group of the Blood Cancer Action Plan.

In Scotland, we sit on the Scottish Cancer Coalition’s Medicines sub-group. Here, we’re holding the Scottish Government to account on commitments in their three-year Cancer Action Plan – including, their promise to improve equity of access to clinical trials and support the NHS Research Scotland cancer network to run more innovative, high-quality studies. We’re also working with patients and healthcare professionals to better understand the challenges facing Scotland’s trials sector, such as poor awareness, geographic isolation or clinical staff capacity, and the potential solutions.