5 tips for expanding your commercial health research studies into diverse settings

The UK research landscape is expanding beyond the hospital clinic to bring people-centred health and care research into a wide range of new and diverse settings. Many research studies are already optimising this opportunity, whereas others are yet to benefit. Life science companies in particular are missing valuable opportunities to make their research more inclusive and address diversity challenges. In this article Sarah Fallon - Network Operations Director for the NIHR Research Delivery Network - explores how commercial sponsors might take steps to improve research reach, and inclusivity, by embracing Agile Research Delivery.

Agile Research Delivery practices have been emerging for many years. Previously this was in pockets, however, we can now boast that this capability is available system wide in England.?

The pandemic provided the turning point. Delivering research ‘outside of the hospital’ became a necessity and, recognising the value and potential of harnessing this rapidly expanding capability, the UK government channelled resource into ensuring this transformation wasn’t temporary.

Over the last three years I’ve had the privilege of providing national and local leadership for this initiative and working with the dedicated Agile Research Delivery workforce. I’ve seen how they have developed into experts at path-finding non-traditional approaches to bring research to different settings. I’ve been inspired by their enthusiasm as they have engaged with stakeholders across the research system, including UK regulators, to adapt, innovate and overcome obstacles. I’ve felt humbled by their collaborative spirit and utter determination to take research to the people who need it most.?

For them, delivering research across multiple organisations, health and care settings, medical specialties and even geographies is now business as usual. It’s also a core component of the new Research Delivery Network support offer.

The timing could not be better.?

Global drive for diversity and inclusivity?

In August the Health Research Authority (HRA) published a report titled ''Addressing the Barriers to People-Centred Clinical Research with Recommendations for System-wide Action'.? Two months before that, in June, the FDA released guidance on Diversity Action Plans. These are now mandatory for certain clinical studies to ensure that participants in clinical trials are representative of the people who will use the medical products.

The message is clear. Research needs to be inclusive, people-centred and must reach diverse and under-served populations.?

Our Agile Research Delivery teams can help make this happen. We’re already delivering research beyond the hospital in diverse environments, including schools, mobile research units (buses), places of worship, community hubs, palliative care settings, care homes, prisons, and also in people's homes.

An untapped opportunity for the life sciences industry

So far, the majority of health and care research that our Agile Research Delivery workforce has helped deliver, (over 80 studies), have been non-commercial; funded by organisations such as research charities, research councils, and the NIHR. This research is vitally important, but we also recognise the value and benefits that commercial research, funded by life science companies, can bring to people receiving care outside of hospitals.

And the numbers demonstrate there is an appetite to participate in health research outside of hospitals. Take the Genes & Health study for example (see case study below: From festivals to places of worship: Bringing research to South Asian communities). Of 1032 participants, 57 were enrolled in the hospital environment compared to 975 enrolled in the community. This is a trend, not a one off - the volume of participants is generally higher out of hospital compared with similar studies that have been placed in hospitals.

We want patients and the public in all settings to be able to access all research opportunities. However, we recognise that there are very valid reasons that some research needs to take place in a hospital or clinic, especially where medicinal products and interventions are required.

But the question is: Do all of the research activities in your protocol need to take place in the clinic??

Push the boundaries to realise the benefits

We know that there are challenges for commercial sponsors around delivering research outside of a clinical setting. We understand that new delivery models in previously unused research sites may involve an increased amount of work for that first study, especially around governance and compliance. But for future pipelines, the lasting benefits of investing that initial time/resource is worth it.

We also know that life science companies are continually working against the clock and that pushing the boundaries to include new research locations and settings may initially add to the study delivery timelines.?

However, if you don’t push those boundaries your research landscape cannot expand and your ability to reach new populations is limited.

Our Agile Research Delivery Teams have worked collaboratively with regulators and NHS providers to overcome a whole plethora of obstacles, such as those associated with indemnity insurance, transport of CTIMPs, and how to get research buses CQC accredited. They have proved that none of these challenges are insurmountable.?

They’ve set new precedents and developed a new framework to operate within which is increasing speed of participation, and reducing the time taken to deliver research (as you will hear from the case studies below) .?

They are actively familiarising our health and care system about how to adapt so we can accelerate our ‘out of hospital’ capability. A new learning resource, due to launch this autumn, will provide even more health and care professionals with the knowledge they need to take research into different settings. As well as widening access to research, this will help to ease the demand on clinical spaces and hospital-based research resources by building and optimising research capacity across the wider health and care system.

Their work is also enabling research to be more people-centred, delivering patient benefits and driving up recruitment and retention.?

We want to help more life sciences companies get in on the action.

Your challenge for today (and some help)

We expect and accept that it will take time for confidence to grow across the commercial sector. So today’s task is small. Going back to that question above: Do all of the research activities in your protocol need to take place in the clinic?

Think about the next study you are planning. Is there one aspect or activity you could make more people-centred with Agile Research Delivery support???

To help, here’s five insightful case studies which showcase how our Agile Research Delivery teams have delivered research in five very different settings. Each conveys recommendations that are summarised as top tips below.

Tip 1: Turn it upside down - start with the people, not the sites

“Don't start with pre-selected sites, and then worry about how your sites will engage the target demographics. Turn it upside down - focus first on the communities you want to reach, then consider the resources that are now available to help you reach those people.”

Read the case study: Bringing research to patients’ homes to improve quality of life through palliative care

Tip 2: Get insights from frontline workers and start small

“Talk to your Chief Investigators and Principal Investigators about care pathways, but don't stop there... Listen to the frontline workers – they have valuable insights. Engage with the people on the ground – the nurses, research practitioners, and clinical trial administrators…. They know the realities of the settings. ”

"Be open to change and embrace flexibility. Don't be afraid to try something new. Start small – maybe with screenings or parts of the protocol delivered outside the hospital."

Read the case study: From festivals to places of worship: Bringing research to South Asian communities

Tip 3: Don’t limit your locations

“Study activities can be categorised into three types: eligibility screening, intervention and follow-up… Eligibility screening and follow-up activities can often be performed in community settings…?

“Being explicit about locations can limit the flexibility and opportunities for more inclusive participation. Instead, protocols should indicate that activities will be conducted at ‘convenient locations’ for participants.”

Read the case study: Agile Research Delivery Team take LOLIPOP study into the community

Tip 4: Rethink who needs to complete the research activities?

“...build flexibility into study protocols when you set out ‘who’ can conduct the research activities. Ensure you can optimise Agile support by broadening your scope beyond clinical staff. Include different health and research professionals in your research protocol, Allied Health Professionals (AHPs), Clinical Trial Assistants and even volunteers can complete a lot of the trial activities…”

Read the case study: Agile Research Delivery Teams take the ELSA study into schools?

Tip 5: Balance the ‘research ask’ with the opportunity of bringing research closer to home with research buses

“I would urge Sponsors to consider whether long observation periods are absolutely necessary and consider whether this can be reduced…

“To maximise the potential of mobile research buses, Sponsors should strive to balance strict protocol requirements with flexibility, and participant-friendly approaches. This will enable access to new participant groups and increase recruitment diversity.”

Read the case study: Maximising recruitment with mobile research buses - a people centred approach?

Ready to embrace Agile?

If you are already on the same page as us as far as Agile is concerned, then help us to understand how we can help you.

To access diverse settings, we really need to get upstream. So before you embark on your Phase 1 trial in a Clinical Research Facility (CRF), have you considered research locations for your phase 3 or phase 4 work??

We need advocates and allies in the life sciences industry; people who recognise the potential and opportunity that Agile Research Delivery presents, and who are willing to keep pushing those boundaries. We want to assist those conversations and hear your feedback. Let’s look at your longer term research plans together, through a strategic lens, so that we can anticipate and navigate the challenges. Talk to us about your pipeline or ask an Agile expert to join your advisory or steering group.?

We can help you lay the foundations for new ways of working.

Contact us

Fill out our contact form, clearly stating your interest in Agile Research Delivery support, to arrange a chat with our team. We aim to reply as soon as possible and always within two business days.

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