Embracing new delivery models in the UK
The clinical research landscape in the UK is on the cusp of a major transformation. Building on the traditional research model the country is welcoming a new era of flexibility, incorporating decentralised, remote, and hybrid clinical study approaches that are poised to change the way research is conducted, enabling equal opportunities and increasing accessibility for individuals across the nation.
At the forefront of this charge is the National Institute for Health and Care Research (NIHR), which has embarked on an ambitious mission to evolve clinical trial delivery, empowering participants to choose how and where they engage with studies. Central to this evolution are the NIHR Direct Delivery Teams, which are not tied to a specific site or therapeutic area; instead, they respond to local research delivery needs as they emerge.
This strategic shift holds immense promise. By expanding access and removing geographic barriers, researchers can tap into large, diverse patient populations that have historically been underrepresented in clinical research. The result? Studies that generate more robust real-world evidence and better reflect the true diversity of the populations they seek to serve.
Of course, realising this vision requires a recalibration of mindsets, capabilities, and operating models, as panellists discussed during a recent pharmaphorum webinar developed in association with the NIHR.
Evolution of clinical research in the UK
The COVID-19 pandemic has undoubtedly been a transformative event for healthcare, serving as a catalyst for out-of-the-box thinking when it comes to designing study delivery models. Faced with the urgent need to conduct research amid the disruption of a global pandemic, researchers were forced to explore beyond the bounds of traditional clinical trial settings. As a result, studies began to expand into unconventional locations, from car parks to rugby clubs, with mobile units showcasing the industry’s ingenuity and adaptability by taking research into community and public spaces.
“One of my first experiences working differently was a drive-through study at a local football stadium in a car park, where we were trialling lateral flow diagnostic devices for the first time ever with COVID-positive people,” recalled Jo Henry, matron for NIHR Clinical Research Network: Greater Manchester. “That study ended up [where] the results came back so quickly because we’d set everything up really quickly. Within 40 days, the lateral flow tests []were rolled out. The pandemic really showed us that we can work smarter, more efficiently, and we can still get that high-quality data.”
Introducing new delivery models quickly began to demonstrate promising results in helping to meet urgent public health needs. However, beyond the pandemic bubble, bringing research outside of the traditional ‘clinical’ setting also illuminated barriers to participation that many would-be research participants faced with site-centric study opportunities.
“Often studies are run in a single location, such as a hospital. It’s a clinical delivery team and a research team, and participants are expected to come to them,” explained Jamie Calderwood, lead nurse for the agile and Direct Delivery Teams. “But there’s a real reluctance from some of our participants and demographics who don’t want to come to those clinical locations."
“People want that choice in healthcare - about where they get healthcare, who they receive the healthcare from,” agreed Henry. “It’s only natural, then, that research needs to come up to those standards as well.”
Calderwood continued: “Research feels almost [that] it needs to be at the patients convenience. If they’re being expected to do extra on top of all the busy day-to-day pressures that they have, there’s an attitude of 'I can’t take anything more on'."
Through the COVID-19 response, however, agile research units showcased how barriers, such as time and financial restraints, could be addressed by reducing the burden on participants. Moreover, Calderwood noted that the decentralised approach which continues to be adopted by researchers post-pandemic, allows them to demonstrate their ability to recruit underserved groups into research studies. He continued to say that studies have demonstrated the need to include underrepresented groups to ensure that any interventional therapies are backed by scientific results.
“There was a genetic study that found that 50% of the South Asian population who were tested didn’t metabolise clopidogrel, which is given to those who’ve had heart attacks as a way to prevent [further] heart attacks,” he explained. “We need to think slightly differently in our approach, the way we identify participants for research, the information we present to them, and really open it up and go to where the people are.”
Pathfinders: Embracing agility
One of the most significant developments across England has been the introduction of Direct Delivery Teams (DDTs) – national teams that respond with agility and flexibility to meet the evolving research landscape.
As Henry explained, “The NIHR received funding from the Department of Health and Social Care to set up Direct Delivery Teams. There are 15 clinical research networks in England, and all 15 now have a DDT. The whole purpose of these DDTs is to establish more research in non-NHS settings.”
She continued: “Because we need to make sure that research is relevant for the people that we’re serving, we do a lot of engagement with local communities, ensuring that the people who need the research get access to research opportunities and access that is convenient for them.”
These DDTs are, as Henry describes them, are “pathfinders” comprising diverse teams of nurses, practitioners, trial administrators, and engagement officers, all navigating different settings and establishing and putting in place appropriate research processes and infrastructure to enable research to take place
Taking research into non-traditional settings, often engaging with research-naive sites and communities, can lead to highly encouraging results. Senior research nurse for the LCRN in Wessex, Kirsty Gladas, shared her DDT experience with the IDX2 trial, which explored early diagnostics for lung cancer or disease. To increase access to patients in areas with high need, the team, she explained, “parked the bus up outside next to the CT scanner, wherever that may be. In the past year, it’s been in a leisure centre, in a supermarket, on a community hospital site.”
Building on the successful preliminary outcomes of the IDX2 trial, Gladas stated that another IDX2 trial would be appearing in mid-2024: “We’re looking to make partnerships with more supermarkets and take the research to where people are to make sure that we’re covering a larger demographic and people aren’t missing out.”
However, navigating these new research landscapes has not been without its challenges. As Henry described, they’ve “had to negotiate their landscapes, negotiate their environments, and figure out how we can make the research fit and work in that space and work with their service users or their clients or their patients.” They’ve had a lot of different challenges and had to work in lots of different ways.
“In the NHS, we’re classed as part of the care team, and therefore we can have access to patient information and their notes and their clinical documentation. Outside of those settings, we’re not classed as the care team or staff for a community centre, for instance," said Calderwood. “We had to look at a way of managing that and also conforming with GDPR and information governance. We [use] honorary contracts as a process certainly within Yorkshire and Humber."
Putting honorary contracts in place with GP practices enables DD team members to perform work on behalf of the practice - like an honorary member of staff. This opens up more opportunities to offer the practice patients a wider range of studies which are delivered on behalf of their usual general practice. This combined with the DD team’s remote and mobile research delivery capabilities means they can take the research to the people.
To address similar challenges to gain access and conduct research in non-NHS organisations, the DDTs have explored various solutions such as; letters of access, research passports and the Universal Letter of Assurance process. This latter approach, as explained by Thanuja Weerasinghe, Lead Research Nurse, Kent, Surrey & Sussex Clinical Research Network, helps to expedite the engagement process with non-hospital settings by providing a standardised pack of pre-engagement checks and human resources information.
“Because all of our Direct Delivery Team members are NHS contract holders, we have our pre-engagement checks done already through the NHS,” he said. “Through this Universal Letter of Assurance process, all of that human resources-related information, which another HR in an outside-hospital setting will need, we give all of that information as a pack and say, ‘This was done in the NHS, and here are the details’."
“The majority of the sites and organisations we worked with were able to use that pack as it is, which actually helped our Direct Delivery Team members to go and start delivering the project in a timely manner.”
The rise of DDTs and their embrace of agile, community-based research models have showcased the healthcare industry’s ability to adapt and innovate in the face of adversity. By breaking down traditional barriers and expanding research into non-traditional settings, these teams are paving the way for a more inclusive and accessible approach to clinical research, ultimately benefiting the communities they serve.
“One thing is clear, when it’s an outside-of-hospital setting, we want to make it easier for them to have our staff in their organisation,” said Weerasinghe. “If there’s anything we can do to cut down the red tape and help their process, then everyone seems to be happy about it.”
Unlocking the full potential of new delivery models
As the healthcare industry continues to evolve in the wake of the COVID-19 pandemic, the role of new research delivery methods has become increasingly crucial. While significant progress has been made, there are still opportunities to enhance these innovative approaches further and unlock their full potential for a more inclusive and accessible research landscape.
One key area of focus highlighted during the webinar discussion was the need to strengthen the collaborative planning stages between DDTs, researchers and sponsors. Calderwood noted that, “sometimes the [sponsors and researchers] are coming to us slightly too late. The study’s already running and struggling to recruit participants; then they come to the DDT and agile teams to ask, ‘Can you help?’. A lot of the protocols that we get, however, aren’t geared to being delivered in a community setting.”
For Calderwood, working “more upstream with both academic partners, and commercial sponsors is essential” to ensure that study designs are tailored to the needs of the target communities.
“It really is key to come to us at that stage when protocols are being developed to look at how we can support that delivery where there isn’t the traditional lab and pharmacy infrastructure around it,” he said.
Moreover, by incorporating the expertise and insights of the DDTs and agile delivery at the protocol development phase, researchers can proactively address logistical and community-specific factors, making the studies more acceptable and accessible for participants, particularly those from underserved communities. Weerasinghe’s insights on the importance of meeting people “where they are” – whether that’s places of worship, shopping centres, or community hubs – highlight the need for a considered, community-centric approach to research participation.
“Quite a lot of organisations would like to run these projects. Unfortunately, one of the problems is they don’t have the capacity, or they don’t have the time,” said Weerasinghe. What we provide from the DDT and research delivery teams is support to deliver projects as well as expertise with good and best practices because we would like to protect our participants, the projects, and the data we collect.”
By leveraging the established trust and relationships within these communities, the DDTs can break down barriers and foster a greater sense of ownership and engagement in the research process. This, in turn, can lead to a more diverse participant pool, generating data that is truly representative of the populations it aims to serve.
Alongside this collaborative planning, flexibility from sponsors is crucial. Gladas emphasised, there needs to be a “call to action for all of those in industry to make the most of us as the national DDT and agile workforce and leads, [and our] skills and expertise.” By embracing innovative methods and being open to adapting trial design and delivery, sponsors can empower the DDTs to reach and engage with underserved communities more effectively.
Final thoughts
Ultimately, this collaborative, knowledge-sharing approach holds the key to realising the full potential of decentralised clinical research in the UK. By taking studies directly to the people and meeting participants on their own terms, researchers can drive a step-change improvement in the scope, diversity, and accuracy of the real-world evidence that informs the development of life-changing therapies.
Integral to unlocking this ambitious vision for the future of clinical research will be the wealth of knowledge and experience residing within the teams pioneering new research delivery models – as illustrated by the NIHR’s Direct Delivery Teams.
Learning from the DDT’s real-world experience navigating this unknown terrain can be invaluable for researchers looking to replicate their successes across the nation, easing the transition from traditional to innovative delivery models and ensuring that these new approaches are refined and optimised over time.
“We have been doing this for a number of years now,” said Weerasinghe. “As a collective group, we are able to provide support to commercial companies and anyone who is looking at these types of studies.”
It’s an ambitious vision, to be sure. However, with the NIHR’s innovative spirit and the lived experiences of its dedicated delivery teams guiding the way, the future of clinical research in the UK has never looked brighter.
“If anything, we’ve got the motivation and desire to continue and really build on what we’ve done so far. I think it’s going to be bigger and better,” concluded Gladas.
About NIHR
The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research. The NIHR:
- Funds, supports and delivers high quality research that benefits the NHS, public health and social care
- Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
- Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
- Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
- Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
The NIHR was established in 2006 to improve the health and wealth of the nation through research and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK Government.
