Solving Kids' Cancer UK's response to Lord O’Shaughnessy’s clinical trial review report 

Earlier this year, the government started work on a review into commercial clinical trials that would be conducted by former Health Minister Lord O’Shaughnessy, in collaboration with experts from the sector. As a charity who funds and facilitates clinical research, Solving Kids’ Cancer UK submitted a formal response to the consultation, voicing the concerns and priorities for children with cancer. Lord O’Shaughnessy’s final report, and the initial government response was published at the end of May. In our response below, we outline our key takeaways, and what we’d like to see next to ensure this piece of work and its outcomes can bring as much benefit as possible to the childhood cancer landscape. 

Setting the scene 

In February 2023, the government appointed Lord James O’Shaughnessy to conduct an independent review of the commercial clinical trial landscape in the UK. The purpose of this review was to provide an unbiased assessment and analysis of commercial clinical trials in the UK, with the aim of identifying problems and making recommendations for improvements.  

This review was prompted by evidence from the Association of the British Pharmaceutical Industry (ABPI) which showed that there had been a 44% drop in recruitment to commercial clinical trials.  This is a problem because fewer clinical trials mean fewer opportunities for British patients to access new and innovative treatments, and because the government recognises that commercial clinical trials are vital to accelerating growth and prosperity of the life sciences sector. 

Many organisations within the charity sector, including ourselves, welcomed this review as we are acutely aware of barriers, delays, and overall inefficiency of clinical trial delivery in the UK. As funders and facilitators of clinical research it is our mission to ensure such research is accessible and can make a meaningful difference to children with Neuroblastoma. 

It is important to note that this review focuses specifically on commercial trials. Clinical trials for childhood cancer including neuroblastoma are rarely commercially led. This means that we must be cautious in assessing how the review and response will impact communities that rely almost wholly on academic and charity-funded research. 

Our involvement 

As an organisation, we are committed to three pillars of work: Research, Support and Awareness. Under our awareness pillar we are focused on raising wider awareness of neuroblastoma and the challenges within the clinical trial landscape. We therefore submitted a formal response to the consultation ahead of the review to ensure that the voice of the rare disease and paediatric population was heard, and aimed to highlight any potential issues where improvements in commercial clinical trials could inadvertently impact academic and charity-funded trials. We therefore made recommendations that were designed to improve the overall landscape for all types of trials, ensuring that the benefits extend to a diverse range of research areas.  

Our recommendations are summarised below: 

  • Harmonising regulations with other countries. 
  • Simplifying the process of initiating clinical trials at local sites through interventions such as centralisation of sign-off processes and introduction of standardised contracting. 
  • Implementing special considerations for clinical research of rare diseases including ultra-rare childhood cancers, such as incentive programmes for industry partners and a unique clinical trial delivery pathway. 
  • An independent review into clinical trials for children’s cancers. 

Summary of the review 

Lord O’Shaughnessy outlined 8 problem statements and 27 recommendations to address them. These recommendations cover a wide range of infrastructure that underpins clinical trials, from approval delays and lack of accountability for trial performance, to proper data transparency and incentives for NHS staff to train in research positions. We were particularly reassured to see the following points, that align with our own recommendations, highlighted in the report. 

  • Any proposals that benefit commercially led research should not be to the detriment of academic studies and provide an overall improvement in clinical trials activity. 
  • Recommendation of clinical trial acceleration networks to produce gold standard trial delivery pathways, that involve relevant charity partners. 
  • Recommendation of a centralised contracting process that eradicates unnecessary layers of bureaucracy at NHS trust and hospital level. 
  • Recommendation that real-time data should be collected, consolidated, and published for all trials regardless of how they are funded or in which settings they take place. 

These recommendations in particular have the potential to bring significantly improvement the clinical trial delivery infrastructure in the UK. We hope that these improvements will bring benefit beyond commercially funded studies and make a difference in the lives of children. 

What will happen next? 

In response to the review, Health Minister Rt Hon Steve Barclay has outlined the government’s commitment to implement the recommendations of the review, starting with 5 headline commitments: 

  • MRHA task and finish group to reduce commercial clinical trial approval to 60-days. 
  • Deliver a comprehensive and mandatory national approach to contracting. 
  • Provide ‘real-time’ data on commercial clinical activity in the UK. 
  • Establish a common approach to contacting patients about research. 
  • Establish 2-3 clinical trial acceleration networks (CTANs) with focus on infectious disease vaccines, cancer and dementia. 

Overall, we are pleased with the outcome of Lord O’Shaughnessy review, and the government’s initial response, particularly the funding to establish clinical trial acceleration networks and the effort to streamline trial approval and delivery. We are also grateful for Lord O’Shaughnessy’s recognition of the importance of the charity sector in sustaining medical research within the UK. 

Solving Kids’ Cancer UK is very willing to contribute to progressing the deliverables identified in the government’s response, particularly in the development of clinical trial acceleration networks that focus on cancer as a research area. We are keen that this piece of work is done in a way that appropriately prioritises the needs of children, who are often left out of major cancer strategies. The new CTANs should not bring additional bureaucracy to the clinical trial setup process, and instead should look to harmonise and build upon the work of existing networks, such as the Experimental Cancer Medicines Centre (ECMC) network and NIHR Clinical Research Networks. Supporting this established infrastructure is a key opportunity to utilise the committed funding in the best and most efficient way, as well as capitalise on their existing learnings and expertise. 

We look forward to the government’s update on their commitment in the Autumn and will continue to engage on this topic, alongside other leaders in the sector including the Association of Medical Research Charities, as work progresses. 

What does this mean for children with neuroblastoma? 

We hope that the learnings from Lord O’Shaughnessy’s report can bring generalised improvements for all clinical trials. However, it is crucial that policymakers have a clear understanding of more complex and nuanced areas of research, with less direct involvement of commercial partnerships, if we are to see true and meaningful benefit for all patients including children with cancer. 

As dedicated advocates for the childhood cancer community, with a special focus on neuroblastoma, we now strongly encourage a similar review and reform specifically targeting the landscape of paediatric oncology clinical trials. By conducting such a review, we can address the unique challenges apparent when conducting research involving children, and further than that those affected by cancer, and pave the way for better treatment options in the future.