PO Q1 2021 - 26
CLINICAL TRIALS
The Future of Decentralized Trials
Alison Muller
Global Head of Marketing
Oracle Health Sciences
decentralized trials methods in the past year. It's reasonable to expect
some of these trial methods to remain.
For the past few years, sponsors and CROs have moved steadily
towards decentralized clinical trials. These shifts apply new
approaches and technologies to clinical trials with the goal of
reducing or eliminating the need for subjects to physically visit
clinical research sites.
Instead, sponsors will employ more and more technology for remote
data collection, and adopt new technology platforms to design
and manage decentralized trials, while also employing advanced
techniques to analyze all the resulting data.
For example, instead of requiring regularly scheduled site visits,
decentralized trials rely on having treatments or medications
administered by the participant or a trained professional at the
subject's home or a local healthcare facility contracted by the
sponsor or CRO. There are also several emerging technologies at play
to support this approach. They range from simple Bluetooth blood
pressure cuffs to smart watches that monitor your heart and activity
rate, to devices that can autonomously measure blood glucose levels
and send the data remotely. These technologies will help eliminate
the need for patients to have to travel to a site to get this information
to their medical team. Advances in technology that allow for this
remote data collection provide a wealth of insight that simply isn't
available in a traditional trial. This additional wealth of data can prove
essential in helping study teams make decisions earlier to positively
impact overall clinical trial timelines.
At the same time, as sponsors make the transition, they are likely
to encounter some challenges along the way. For instance, having
to make changes to systems and processes so they can handle the
increased volume of data that decentralized trials generate and the
novel data sources and formats that decentralized clinical trials bring.
They also will have to learn to work closely with regulatory agencies
that, despite broadly encouraging these new approaches, have yet
to update mountains of regulations that are often unclear when it
comes to new trial components, or simply don't address them at all.
Why Decentralization Meets Today's
Clinical Trial Needs
The transformation of clinical trials meets two growing needs in the
life sciences industry.
Before COVID-19, most companies treated decentralized trials as
pilots or proofs-of-concept. They may have added some decentralized
components to traditional trials, or even in a few instances undertaken
trials that were largely decentralized; however, dipping into this
approach was largely experimental. With established procedures
providing a level of comfort and familiarity - and regulatory
acceptance - there was no sense of urgency in making decentralized
trials more mainstream.
The first is supporting today's patient-centric approach to healthcare,
in general, and clinical trials, in particular. It was already becoming
harder to find and enroll patients in trials, both for large-scale trials
(like those now underway for COVID-19 vaccines) or those focused
on rare diseases or " precision " medicine treatments, where the pool
of potential participants is quite small. Sponsors have also come
to recognize the need to enroll a more diverse patient population,
representing a range of ethnic groups as well as ages and genders,
as various therapies can have different results or adverse effects in
some groups.
The pandemic created huge challenges for conducting traditional
clinical trials, and with the urgency surrounding COVID-19 vaccines
and treatments, it highlighted the need for, and accelerated the move
to, decentralized trials.
Thus, it became imperative to figure out a way to make trials accessible
to people living too far from research centers for travel to be practical,
or to people with cancer or other conditions for whom travel is difficult,
uncomfortable, or impossible. Alternatives such as telemedicine
for patient interactions with clinicians, visiting home nurses to
administer medications or collect vital signs, and tablets for patient
diaries became attractive solutions. These and other approaches that
Now, nearly a year into this health crisis, the industry attitude toward
decentralized trials has changed.
According to a recent survey of 252 clinical research professionals
from around the globe conducted by Informa Engage on behalf of
Oracle, 76% of clinical trial teams say they have sped up the use of
Pharmaceutical Outsourcing |
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| January/February/March 2021
PO Q1 2021
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