CROs play a crucial role in facilitating the shift of care from hospital to the community and supporting increased commercial clinical trials activity across the UK.
Experts, the government, and the health service have identified three shifts that will be the focus of the UK Government’s 10 Year Health Plan:
- Moving care from hospitals to communities
- Making better use of technology
- Focussing on preventing sickness, not just treating it
Despite a key focus on providing more healthcare in the community, at places like GP surgeries, pharmacies, local health centres, and in people’s homes, commercial research activity is still primarily delivered in a hospital environment. CROs can play a crucial role in realising this seismic shift in the delivery of research activity.
Several factors are propelling the movement towards community-based clinical research. Firstly, there is a growing emphasis on diversity and inclusion. Hospital populations may not always represent the broader demographics of patients with specific conditions. Community-based research can allow for greater diversity in trial participants, ensuring findings are more applicable to a wider population. Secondly, increased recruitment can be achieved by conducting trials in the community, rather than relying on complex referrals from community to hospital settings. A participant-centric approach is another key driver, as community settings are often more convenient and accessible for patients, leading to increased participation and trial retention. Additionally, real-world data is captured in community-based trials, providing insights into how treatments perform in everyday settings. Finally, shifting some research aspects to community settings can offer cost-effectiveness, potentially reducing costs such as travel expenses.
Role of CROs in Supporting the Shift
The right site for the right study
CROs have a powerful role to play in shifting sponsor decision making around site selection from relying on traditional principal investigator relationships to a participant-centered approach. Based on NIHR data regarding site selection, commercial study sponsors consistently show a preference for placing studies at sites where pre-established relationships exist. These pre-existing connections significantly impact study placement decisions. CROs can play a key role in challenging this reality:
Achieving the move from hospital to community in clinical research hinges on considering feasibility from the participant’s viewpoint:
- Where are eligible participants for your study seen in the healthcare system to manage their condition? They are much more likely to participate and to remain in the study if it is in a location they are already familiar with and used to attending.
- Complex referral pathways can result in wasted time and effort, as well as missed opportunities to screen eligible participants. Can you open the study in the right location instead, avoiding the need for referrals?
- If a community based location is not feasible, are there specific elements of the study you could deliver closer to home? Convenience is key to participation and retention.
At the NIHR we understand that delivering commercial research in new areas and locations can come with a level of risk, without having the intelligence and data you need to make informed decisions. That’s why we provide a suite of free tools to support sponsors and CROs. Our Scoping Locations for Research Tool enables you to compare prevalence, ethnicity and deprivation score data aligned with information on research activity. This means you can first identify areas with high prevalence for the relevant condition, matched to relevant research experience for the potential sites in those areas. Once you are ready, you can then use further free NIHR services to gather expressions of interest from all relevant healthcare providers across the country.
Non-traditional staffing options
To deliver commercial research in a wider care setting, sponsors and CROs need access to highly experienced research delivery professionals that can work across multiple settings, geographies and organisations. Clinical research is no longer confined to hospitals. Through the Agile Research Delivery Teams, the NIHR is actively conducting studies in a variety of community settings, such as schools, mobile research units, places of worship, community centers, palliative care facilities, care homes, prisons, and individuals’ own homes.
Our Agile Research Delivery team has supported a huge number of studies, predominantly non-commercial (funded by research charities, councils, and the NIHR). While this research is crucial, we acknowledge the significant advantages that commercially funded research from life science companies can offer individuals receiving care in community settings. This would facilitate a shift from hospital-centric clinical research towards community-based studies. Think about the next study you are planning to bid for or one you are currently running. Can you deliver the follow-up visits in a community or home based environment?
