How we use a decentralised trial methodology

At Lindus Health we are accelerating the pace of research and making clinical trials more accessible to a diverse patient population by decentralising trials using our in-house technology.

By conducting an increasing proportion of trial activities in the comfort of a patient's home, we have reduced the number of in-person trial site visits needed. Patients are able to undertake all (fully decentralised) or some (hybrid design) trial procedures remotely from the comfort of their own home.

While certain elements of clinical trial decentralisation existed before the COVID-19 pandemic, they were not commonly used across trials. The pandemic forced the research industry to adopt and deliver decentralised clinical trials, with 80% of CROs predicting that they will conduct decentralised trials by 2021-2022 (EndpointsNews Survey, May 2021). This transition was driven by the need for urgent public health trials to quickly find treatments and vaccines for COVID-19, where delivering trial procedures remotely to participants became a necessity.

The introduction of these innovative and more efficient procedures exposed the limitations of the traditional site approach, and has changed the future of clinical trials.

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The traditional site approach

Using the traditional clinical trial approach, participants are recruited and managed by investigator sites such as GP practices, hospitals, and research facilities. At each site a Principal Investigator (PI) is responsible for the oversight of the clinical trial. Having multiple PIs for multi-site trials adds layers of complexity and inefficiency to even the simplest trial design.

The traditional site approach requires participants to attend multiple in-person site appointments, rarely at convenient times, nor locations. These visits routinely make recruiting a diverse population extremely challenging and exclude participants who are older or more frail, endure severe illness, or experience side effects.

During the pandemic, the traditional site approach was often not fit for purpose, as many Investigator sites paused research activities to direct all available resources to the demands of the pandemic. As sites gradually started to reopen for research activities, face to face visits were simply not a possibility for many participants; shielding and isolation took priority. As a result, novel ways of working were developed, with regulatory bodies approving flexible and proportionate new approaches.

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Our decentralised ‘virtual site’ approach

At Lindus Health we can act as a virtual site to deliver clinical trials. This means taking on all (traditional) site responsibilities with the oversight of a remotely based Principal Investigator (PI). For fully decentralised trials all activities occur remotely. Whilst, for hybrid trials certain procedures occur in-person, (when they either can’t be completed at home or for more complex and higher risk trials) either at one of our affiliated primary or secondary care sites, or at the patient’s home with a trained research nurse.

The capabilities and flexibility that decentralised trials offer is fully embedded in our type 2 diabetes trial: investigating whether a remotely delivered intervention consisting of total diet replacement and the Habitual digital therapeutic application, induces diabetes remission.

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Conclusion

At Lindus Health it is our mission to improve patient care at a faster pace, and we achieve this through the use of innovative technology to deliver patient-centred research which improves participant recruitment and retention.