Embedding clinical research in pathways is key to global superpower status

<sup>Panel left to right: Dr Nik Johnson (Mayor, Cambridgeshire and Peterborough),Tom Keith Roach (UK President, AstraZeneca) and chairing: Angela McFarlane (Senior Vice President, IQVIA) . Other panellists were Michelle Mitchell OBE (CEO, Cancer Research UK), George Freeman MP (Science Minister), Dr Julia Wilson (Associate Director, Sanger Institute)

This article is the third in a series of three features recounting a panel Q&A session conducted on January 20th in Cambridge at the Cancer Research UK Cambridge Institute, for a full video of the event click here. For the first feature click here. For the second feature click here.</sup>

Improving the data infrastructure

Calling for innovation to work “end-to-end”, Managing Director for Global Health and Life Sciences at Palantir, Dr Justin Whatling asked the panel how safety data can be monitored to see how innovations roll out and then incentivise adoption and uptake. Making an interesting point around how commissioners are going to need to make value-based decision making in the new system of Integrated Care Systems (ICS), he called for an opportunity to explore how data is used with citizens, rather than a national data-architecture along the lines of care.data.  Associate Director of the Wellcome Sanger Institute, Dr Julia Wilson agreed that a single data infrastructure is not what this country needs. Instead, she called for a “federated approach”, where many datasets within a data network can be accessed through a single portal. 

Highlighting the importance of privacy, Dr Wilson said “we need to consider public trust in all the research and innovation that we’re doing. We have made some great strides in the UK already with, for example, Health Data Research UK” that works to mobilise routinely collected health data for research and there is a single portal you can enter to get access to data tools, publications and research projects.

In an exciting development, Dr Wilson outlined another novel idea that the Wellcome Sanger Institute is adopting in the UK, which is the idea of ‘passports’ for researchers. They hope this will enable a scientist, researcher, or clinician to be given a passport to authenticate access to multiple datasets.

Calling for all players in the ecosystem, from basic researchers, innovators and healthcare practitioners to work together, Dr Wilson highlighted the opportunity to improve connectivity and interoperability between datasets. Supporting this call, the Minister highlighted that government has “poured billions into health IT and it hasn’t transformed the frontline or delivered an integrated research ecosystem.” Instead, he wants to see government support the growth of up to ten life science clusters around the UK – including Oxford, Cambridge, Manchester and Birmingham.

Reforming NICE

Reflecting on rising costs and poor health outcomes, the Minister said “in my 10 years in Parliament, health [spending] has gone from 30 per cent of national budget to about 42. It’ll be 52 in the next 10 years. This is not sustainable; we can’t keep filling up our hospitals with people with chronic diseases.” Outlining his vision to solve this, he thinks the UK needs to “localise, integrate and incentivise.”

During his first Ministerial role in Government, the Minister had planned to reform the NICE-NHS England relationship to ensure that there was some health economic background behind decision making. He outlined his “worry” that NICE is in danger of being drawn into becoming a “no” vehicle for the NHS. Instead, his vision for NICE is to be more of an international global health economics house – “setting pathways, sometimes into the NHS.” This may save money, but it is more likely to save lives. In defence of NICE, panel chair and Vice President, Strategic Planning, North Europe, IQVIA, Angela McFarlane said that in recent years, NICE has said “yes” more than ever – approving 95% of appraisals. She emphasised that the problem involves implementation and uptake at a local level.

The Chair was supported by the AstraZeneca UK President, Tom Keith-Roach who fed back that one of the opportunities to come out of Brexit is to think about the MHRA and NICE as globally leading organisations that are fully empowered to innovate. Giving the example of joint work between NICE and the MHRA, Project Orbis that reviewed and approved promising cancer treatments with the US Food and Drug Administration (FDA) has repositioned the UK as a valued global partner.

Praise of innovation at NICE was contrasted with the situation at NHS England, Keith-Roach said negotiations with them were “about affordability, not about value.” Reflecting on the access environment in the UK, highlighting that in the most forward-thinking Clinical Commission Groups (CCGs) they adopt innovation fast, however in some areas across the country there is no adoption of innovation at all, which is a “massive driver of inequality.” Once something has been proved to have value through NICE, albeit at a low price internationally, the burden of proof should then be on the local system as to why they are not adopting it. 

“I don’t think anybody’s saying that they expect the UK to pay sky-high prices for innovation and when you look at the data, what’s interesting is we’re not slow at adopting innovation everywhere,” he said.

Keith-Roach called on government to give the CQC “statutory powers” to audit and ask, “why is there unwarranted variation in care?” and “why are you not adopting technology for patients that has been proven to improve outcomes and proven by NICE to be cost-effective?” In support, the Minister suggested the need to be transparent with a green, amber, red warning light system with a renewed focus on democratic accountability.

Exploring the thoughts of the panel on embedding research in routine care, Dr Wilson suggested that we still need the engine of discovery science before research can be embedded into routine care. Citing the CRUK campus as a great example of bringing academics, commercial and healthcare activity together – close to the clinic, she said “we need a space where we can bring together co-location of academics…because that’s the only way you’re going to do it in an integrated way.” Following these inspiring comments, the CRUK Chief Executive, Michelle Mitchell said that continued investment in discovery science is critical and “it is only through science where we discover new ways to prevent, diagnose and treat.”

The engine of discovery science

Pointing to the “decimation” of clinical trials during the pandemic, Mitchell called for the Government to rethink the ways to make the UK globally competitive. The NHS is a unique differentiator for the UK but warned, “there is very little time to do research in the NHS.” There is a need therefore, to refocus clinical research as a priority. Pointing to the success of the Covid Recovery Trial, an innovative trial design that was set up in just nine days, Dr Wilson suggested that this was only possible with continued investment in UK life sciences, infrastructure and discovery science. This success was demonstrated to the world and rightly applauded.

A final important point was raised by the UK President of AstraZeneca, “we have to stop thinking about clinical development and routine care as a separate thing.” The evidence is incredibly compelling, “when you’re doing clinical research you have great care and you have better outcomes for patients.” As the Chief Executive of the National Institute for Health Research Clinical Research Network (NIHR CRN) was in the audience, the Chair invited William van’t Hoff to respond. He advised, “research is difficult in primary care and in the home, so translate and use a new language of research when you want to empower people to get involved and then they will come to it when they see it as relevant to their direct care.”

Final Thought

As the new Chief Executive of NHS England, Amanda Pritchard finalises her vision for the updated NHS Long Term Plan, clinical research must be front and centre.  A renewed focus on clinical research and discovery science in the NHS is a win-win for patients. Outcomes improve and costs are reduced.

Adoption has been a problem for the NHS for years and it will require more than a rethink to make change happen. The success seen during the pandemic is a global exemplar and it is a great opportunity for the life sciences sector, including the Cambridge cluster, to attract global life science companies and researchers to the UK.

As the Minister continues to adhere policies to his mission, there is not much time to capitalise on the opportunities. The UK must deal with record high NHS waiting lists, patchy adoption of innovation and the accompanying access issues as well as restoring and expanding clinical trials and research if it is to become a “life sciences superpower”. If it fails, it will mean lower investment, slower scientific discovery and sadly, poorer outcomes for patients.