Why commercial sponsors should continue to choose the UK when delivering clinical research

In the race to market, country and site selection are high-stakes decisions among commercial sponsors of clinical research.

For the UK, it’s imperative that we continue to attract research to ensure access to innovative treatments for patients. Could country-wide, data driven placement, enabled through a partnership approach, be the solution to bridge the gap?

The UK life sciences industry is at a crossroads, according to recent reports. Among these, the ABPI-authored Rescuing patient access to industry clinical trials in the UK (October 2022) asserts that the UK has dropped in global rankings from 4th in 2017 to 10th in 2021 for phase III industry-sponsored clinical trials.

Consequently, the needs of UK-based teams working in the global life sciences industry are evolving beyond trial set-up and delivery, by also seeking greater confidence in where they place their business in the first place.

What if you could simply ask – where is the best place in the UK to deliver a phase 3 type 2 diabetes study? Or, how do I quickly find five research-ready sites in the UK to deliver chronic liver disease trials?

Reliable answers to those questions must consider disease prevalence, population demographics, investigator expertise, site capability and capacity, and recruitment track records. Secondly, they require reference to real-time national research activity data to target studies to the right place for timely delivery and to avoid wasting resources at saturated sites.

Undoubtedly, hard data plays a key role here, and artificial intelligence may well help interrogation of that data in the near future. But what about the softer intelligence? For example, the speed of response to email requests, or understanding practical aspects about the function of disease-specific NHS clinics?

In the UK our unique research system, embedded within the health and wider care setting, enables industry to access these nationwide insights, free of charge, to inform its study placement using a partnership approach.

In these study-specific scenarios the concept of ‘placement through partnership’ is not just data-based. It relies on a combination of data, NHS clinical expertise and a UK-wide research infrastructure of interconnected research active NHS sites.

Yet the concept of “placement through partnership” goes further than just identifying the sweet spots for recruitment. It’s about better distribution of research, both geographically and across the various care settings. It’s about equality of access for patients across the entire UK. It’s about understanding and utilising all the capacity in the system to deliver research results as quickly as possible.

It’s also about building new research capacity and capability – by unlocking new locations or investigators for companies we enable research-naive sites to grow their expertise and experience. The investment that follows the research activity further builds the research infrastructure.

We recognise that sponsors hold their own information about where to go – which relationships have worked well, what recruitment strategies delivered results. Tried and tested will often trump new and novel.

Yet without sponsor selection, the ability to sustain and expand research capacity for the future will be limited. So how can we work with sponsors to complement the information they hold, while encouraging them to add that unfamiliar site to their site list?

The answer is to engage earlier and work in collaboration, and it’s mutually beneficial on multiple levels.

At the study-specific level early conversations create opportunities to understand what information might help guide particular decisions. They also open doors to new ideas and suggestions for novel approaches, as well as enabling sense checks of site selection and recruitment strategies.

Zooming out, visibility of entire study pipelines enables better planning and predictability, which is potentially a game changer amid the current NHS capacity challenge. Correspondingly, sponsors tell us that earlier visibility of site capability and capacity would help to influence global decision-makers to include the UK at country selection level.

Both are achievable by adopting a symbiotic approach, which harnesses the countrywide research insights and approaches, to enable a more proactive way of working. We are beginning to see a shift in mindset as more sponsor companies and their Contract Research Organisations (CROs) are choosing to work in this way, becoming more curious about what is possible and flexing their approach.

For investigators, the concept of becoming involved in a programme of research studies is compelling and encourages transparency – an important ingredient for partnerships that last.

‘Placement through partnership’ motivates us to think about the impact of the research on the whole UK system – how can we accommodate research as quickly as possible, while best serving patients’ needs, and in a way that helps us to build research capacity and capability for the next study?

In essence, it’s about getting the right research, in the right place at the right time and in the UK support exists to help make this happen. Our access to rich, digital health data sets is rapidly expanding and we’ve been collecting nationwide data on research activity for well over a decade.

This is combined with our government-funded, connected research system, embedded in our health and care service, offering free support to commercial sponsors that are keen to explore research opportunities in the UK. Does any other country boast a similar CV?

Delivering research successfully requires a multilayered, multi-partner solution. Everyone has a role to play in making research a success for the benefit of patients worldwide. Industry can help by being open to exploring the possibilities of study placement in partnership.

Nicola Yallup is Head of Business Development and Marketing at the National Institute for Health and Care Research (NIHR) and Laura Bousfield is Head of Feasibility and Start-Up at NIHR.
Go to nihr.ac.uk/industry-study-support-service