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0:00
Hello. My name is Ada Middleton.
I'm a Senior Director in
the Patient Innovation
Center at Parexel,
a contract research organization
focused on supporting
the development of
innovative, new therapies
to improve patient health.
I'm delighted to provide
an introduction to
the topic of decentralized
clinical trials.
0:19
For today's talk, we'll
go through a definition
of DCTs and speak about
why they are important.
I'll also talk about
the approach to
DCT and some key components,
also strategy considerations,
benefits and challenges,
and talk about DCT adoption.
0:35
Let's start with a definition.
Decentralized
clinical trials are
defined as studies
executed through
telemedicine and mobile or
local health care providers
using processes and technologies
differing from the traditional
clinical trial model.
Within the clinical
trials industry,
there are many terms used
for these types of trials.
Virtual, remote, decentralized,
site-less, direct-to-patient,
direct-with-patient.
The term DCT (decentralized
clinical trial) is consistent
with the FDA preferred
nomenclature and
is the term that I will use
throughout this presentation.
1:10
Why are DCTs important?
Have a look at the
numbers on the slide.
As you can see, it is common
for study timelines
and data to be
negatively impacted by
recruitment problems and
participant dropouts.
Contributing to these issues
is the fact that the majority of
potential participants
live more than
2 hours away from their
nearest study center.
DCTs aim to maximize patient
access and experience,
focus on data quality,
and provide enhanced
recruitment and retention
options while maintaining
or improving costs.
