Tough questions for tough times in clinical research

Udai Banerji is NIHR Professor of Molecular Cancer Pharmacology and Deputy Director of the Drug Development Unit at The Institute of Cancer Research and The Royal Marsden Hospital NHS Foundation Trust. He is also an honorary consultant in medical oncology.

The COVID-19 pandemic has shown that trials can be set up in weeks and findings implemented within months. The UKRI RECOVERY trial changed practice in the way we care for patients with COVID-19 infections. So, what can be done in the cancer space to cut bureaucracy (both funding decisions and regulatory submissions) that will accelerate clinical research?

Hello Udai,

We agree that governments, regulators, and others across the sector can come together to streamline cancer research and deliver improvements to patients’ care faster. We are involved with several streamlining initiatives, including:

• The Experimental Cancer Medicine Centre (ECMC) Network’s pilot to set-up Phase 1 cancer trials, which is being delivered in collaboration with the Medicines and Healthcare Regulatory Authority (MHRA) and the Health Research Authority (HRA).
• The MHRA and HRA’s proposals for updating clinical trials legislation, which include a heavy emphasis on streamlining regulation and learning from the pandemic.
• The cross-government vision for the ‘Future of UK Clinical Research Delivery’ and ‘Life Sciences Vision’, which both prioritise streamlining clinical research, including the use of innovative trial delivery models and making the NHS more innovation-oriented.

We continue to explore additional opportunities to work with the governments of all four nations to streamline cancer research and spur innovations that will benefit people affected by cancer. That’s why regulation is a focus for our policy work as we seek to drive change in this area.

In terms of our own funding processes, we’ve increased the frequency of the Clinical Research Committee meetings from 2 to 3 per year, which means there’s less time for applicants to wait between funding rounds.

Laura Rooney is a Cancer Research UK Lead Research and Information Nurse at the Institute of Cancer Sciences, University of Glasgow. She is also a research nurse manager in haematopoietic stem cell transplant and cellular therapies.

What you are doing in terms of policy work to support the promotion of, recruitment to and protection of cancer clinical research nursing posts? There is an acknowledged shortage of cancer nurses across the UK and the instability of research funding makes the roles less attractive, as they are often fixed term posts. However, without this essential workforce, none of the vital trials could be delivered.

Hi Laura,

We agree, recruiting clinical research nurses is challenging, and this is compounded by the shortage of skilled cancer nurses.

We directly fund 15 senior research nurses across the UK. We also fund, or part-fund, more research nurses through other infrastructure or clinical trial awards.

Last year we published a report on research in the NHS, Creating Time for Research, and we’ve repeatedly recommended the UK Government does more to provide research opportunities for nurses, including cancer research nurses. Our report found that nurses, alongside other professions underrepresented in clinical research, are more likely to face barriers preventing them from participating in research. For example, 36% of nurses and midwives report difficulties accessing research training compared with 25% of doctors.

Last year, we were pleased to see the Government announce £30m for research skills and training opportunities for underrepresented professions, including nurses across the UK. This is a welcome step towards supporting clinical cancer research nurses. This investment follows an earlier commitment to facilitate greater recognition of nurses’ research contributions in the cross-government vision for the Future of UK Clinical Research Delivery implementation plan. This will soon be followed by a multi-year Saving and Improving Lives vision that we will input into – and securing further support for nurses in research will be one of our priorities when we do so.

We absolutely recognise the importance of clinical research nursing roles in clinical trial delivery and we’re continually exploring opportunities to engage with them to better understand the challenges they face and how we might support them in their roles.

Professor Judith Bliss (NIHR Senior Investigator) is Director of ICR-CTSU and Team Leader of its Breast and Rare Cancers Trials Team as well as Deputy Head of ICR’s Division of Clinical Studies.

You have a great reputation for funding both clinical trials research infrastructure and practice changing trials, complementing a focus in experimental medicine. As the government has published its future vision for clinical research and as NIHR pushes its research recovery agenda, how does Cancer Research UK plan to keep its edge as a leading funder for trials influencing mainstay treatments for cancer patients?

We’re proud to fund many trials that have changed clinical practice and improved treatments and outcomes for patients, and we will continue to do this (for example, the STAMPEDE trial and the IMPORT trial).

Where we think we can add most value is to ensure studies that aim to change clinical practice also aim to advance understanding of cancer, for example by helping us understand how tumours develop, grow and spread, how they interact with the rest of the body and how they evolve and evade treatments.

This is where we think Cancer Research UK can make a unique contribution that will benefit people affected by cancer now and in the future.

Dr Richard Lee is a consultant physician in respiratory medicine and Champion for Early Cancer Diagnosis at The Royal Marsden NHS Foundation Trust. He is a team leader for the Early Diagnosis and Detection Team, in the Division of Genetics and Epidemiology at the ICR.

What are you doing to strengthen donor and government funding of early diagnosis research in the current economic climate?

Hi Richard,

Addressing the historical underfunding of research into early cancer diagnosis is a core focus of our Early Detection and Diagnosis Roadmap. Since we published the roadmap last year, we’ve engaged with the UK Government to advocate for an increased focus on early detection and diagnosis cancer research and for Government action to address barriers in this field such as underinvestment. We’re pleased that early cancer diagnosis is one of the focus areas for the cancer healthcare mission in the Life Sciences Vision, which provides a strong platform for further government support for this vital field of research.

How can charity funders work more closely with each other and with NHS England, cancer alliances and the National Institute for Health and Care Research to co-fund translational research?

In our new research strategy, we are clear that we want to learn as much as possible from every patient recruited onto our trials. We want to support scientifically driven studies that use and analyse biomarkers and imaging, producing valuable biological and clinical information that will optimise treatments.

Funding is not always the biggest hurdle in supporting this research. Designing and delivering informative translational studies is extremely challenging, requiring input from a range of experts – clinicians, biostatisticians, bioinformaticians, translational and discovery scientists, as well as patients.

TracerX is a great example of a hugely ambitious translational programme we’ve supported. It’s building a detailed understanding of how cancer evolves and helping us to understand how best to treat cancer as it develops. And while we’re the main funder, it’s also supported by NIHR via the UCL Biomedical Research Centre and other funders.

How can the Early Detection and Diagnosis Roadmap adapt to the challenges of the pandemic to recover research activity in early detection?

Over a year since its publication, the challenges we identified in the roadmap remain and are compounded by additional pressures from the pandemic, further delaying cancer diagnosis. As the NHS recovers, we hope the roadmap can gain greater significance and the research community responds to those challenges by applying learnings from the last two years.

For example, using data to identify those at highest risk of developing cancers would build on effective data strategies deployed during the pandemic to track symptoms, find outbreaks, or identify useful therapies for COVID-19. This is an area of research that could be of great benefit during post-pandemic recovery, helping the NHS prioritise the patients most in need as the diagnostic backlog is cleared.

Additionally, the scale up and roll out of the vaccination programme shows that the NHS can be adaptable and responsive, which would benefit the innovation and adoption of new early detection technologies into practice. The Cytosponge, for example, is a pill on a string used to identify early changes to cells associated with oesophageal cancers and has been used as a triage tool for endoscopy, which was severely limited during the pandemic. It’s currently in practice as part of all health boards across Scotland and continues to be part of pilots across England.

The socialisation and now widely accepted notion of self-conducted testing, whether it be lateral flow or RT-PCR tests, has demonstrated that majority of the population are able to conduct these with relative ease (with appropriate medical advice). Therefore, it gives us confidence that people would be more engaged and confident with approaches like faecal immunochemical test that is part of the bowel screening programme, and other future innovative self-administrated cancer detection and diagnosis tactics.

How do you think you can best help to join up research initiatives and delivery between funders (eg NCRI, NIHR, NHSE) in early detection?

We firmly believe that it will take a village to drive progress in early detection and diagnosis. We continue to demonstrate this ethos by bringing researchers from diverse disciplines together to tackle early detection and diagnosis challenges head on.

We recently partnered with UKRI on an innovation sandpit for new technologies for primary care triage. Researchers from the MRC and EPSRC communities came together with our research community to generate novel, out-of-the-box ideas to help GPs diagnose cancers faster. And now, all three organisations will fund new projects from this sandpit.

We’re also engaging with the NCRI and NIHR on key early detection strategies and initiatives. For example, we’re co-funding the BEST4 trial with NIHR to establish how best implement the Cytosponge test to detect Barrett’s oesophagus.

We’re eager to do more as we work to make all cancer diagnosis at stage 1 or 2 a routine clinical reality. Translational research embedded within the health service will be key to ensure that we learn as much as we can from every patient and trial participant, to bring forward technologies and approaches that see cancer being detected earlier.

Many thanks to Udai, Laura, Judith and Richard for their questions, and the Cancer Research UK Policy Development, Early Detection and Prevention, Research Nurse and the ECMC teams for their input to the answers.

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