How Decentralized and Hybrid Trials Can Drive Efficiencies Beyond the Pandemic

May - June 2022

How Decentralized and Hybrid Trials Can Drive Efficiencies Beyond the Pandemic Editorial Summary Decentralized clinical trials are designed to optimise patient enrolment and participation by reducing or eliminating the need to travel to specific study sites. This can be achieved using wearable digital health devices.

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raditional clinical trials place a significant responsibility on patients and caregivers. There are also additional costs of transportation, accommodation, and food. Currently patient recruitment onto trials is one of the main challenges in clinical research.

When the pandemic hit in early 2020, the world’s first response was panic. But quickly we learnt how to cope by using the tools already at our disposal.

For the clinical trial industry this included decentralized and hybrid trials. The first decentralized clinical trial was successfully completed over a decade ago, but it took a pandemic for us to fully realise its benefits. As companies raced towards a COVID-19 vaccine, we saw that those who were quick to adopt decentralized approaches reaped the rewards.

And we saw how digital solutions opened up access and removed long established barriers to participation.

Mr Nico O’Kuinghttons Vice President, Huma Charlotte NC, United States

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Now we’ve uncovered the potential of digitalfirst research, it looks as though it’s here to stay. Analysis suggests 2022 will see around 1,300 trials with a decentralised or virtual component1. That’s an increase of almost 30% on 2021 figures, which is very encouraging news and suggests a very positive outlook for the year ahead.

But adopting digital approaches hasn’t been easy and we’ve learnt a lot along the way. To drive more efficient decentralized and hybrid trials beyond the pandemic, there are a few things worth keeping in mind.

Wound Masterclass - Vol 1 - June 2022

Plan For Digital From the Start Once the realities of the pandemic became clear, patients began to limit their activity and avoid even important trips to trial sites and hospitals. To minimise trial delays or closures, companies turned to decentralized and hybrid approaches. In many cases this meant plugging technology into plans that weren’t originally built for digital. We know that the efficiencies are there when we embed digital tools into the clinical trials process but to see the full benefits of these approaches we need to account for them from the start.

One Size Doesn’t Fit All So you’ve included an app in your trial design to collect some patient-generated data. But just because you have this, it doesn’t mean that everyone will want to use it. You need to meet people where they are. While some participants may be happy to do everything through an app, others might prefer to travel to fill out a survey with someone in person. If you’re going to digitise you still need to give participants multiple options so they can pick what works best for them.

Consider Existing Workflows Clinicians, patients and sites all have established routines that they’re used to and are comfortable with. Digital needs to be an ally, fitting in with existing processes and workflows rather than disrupting them. By making sure that you’re including every stakeholder in the mapping and implementation of a digital solution, we can bring efficiencies and empower people,

How Decentralized and Hybrid Trials Can Drive Efficiencies Beyond the Pandemic

“Clinicians, patients and sites all have established routines that they’re used to and are comfortable with. Digital needs to be an ally, fitting in with existing processes and workflows rather than disrupting them.”

rather than create complications.

References

Partnering With Sites Instead of Alienating Them

1. Kezia Parkins and Andrew Hillman 2022 2022 forecast: decentralised trials to reach new heights with 28% jump Clinical Trials Arena [Online] Available at: https://www.clinicaltrialsarena.com/analysis/2022-forecast-decentralisedtrials-to-reach-new-heights-with-28-jump/

Sites and investigators are vital stakeholders who must be a part of the planning, implementation and successful delivery of digital solutions. Unfortunately, the use of the term ‘decentralization’ often neglects the voice and role of sites. Sites should be viewed as trusted partners. We need to engage and empower them so they can usher the use of digital solutions and effectively assist patients on the front lines.

Delivery For Patients At the end of the day, trials are about patients and their journey. Patients are lending themselves to participate, so in return we should strive to see the process through their eyes and put them at the centre of what we do. If not, we’re doing them a disservice. We must challenge ourselves to learn from our experiences during the pandemic and continue to deliver innovations for them.

Wound Masterclass - Vol 1 - June 2022

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