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Printable Handouts
Navigable Slide Index
- Introduction
- Agenda
- What are decentralized clinical trials/studies?
- Why are DCTs important?
- Patient centricity
- Diversity & inclusion
- Clinical trial approach
- Decentralized clinical trials
- The importance of patient insights
- The patient is our guide
- For patients and the study team
- Telemedicine
- eConsent
- Patient engagement through smartphone application
- Sensors and wearables
- Home nursing
- Community care
- Direct-to-patient shipments
- Determining the best DCT options for a trial
- Challenges/benefits of DCTs
- DCT adoption
- Emerging and evolving roles in DCT
- DCTs of the future
- DCTs with the patient as our guide
- Thank you!
Topics Covered
- Decentralized clinical trials definition
- Patient centricity
- Virtual trials
- eConsent
- Digital health technology
- Telemedicine
- Home nursing
- Sensors and wearables
- DCT benefits and challenges
Links
Categories:
External Links
- Slide 3: CTTI Recommendations 2018: Decentralized Clinical Trials
- Slide 4: Reference 1 (Percentage of recruiting studies by location, as of Jan 31. 2023)
- Slide 4: Reference 2 (Decentralized clinical trials: are we ready to make the leap?)
- Slide 4: Reference 3 (Sanofi launches new virtual trials offering science 37)
- Slide 4: Reference 3 (No place like home? Stepping up the decentralization of clinical trials)
- Slide 4: Reference 4 (Why do patients drop out of clinical trials?)
- Slide 4: Reference 4 (How one pharmaceutical company is reinventing the clinical trial)
- Slide 6: FDA: Enhancing the diversity of clinical trial populations
- Slide 15: Successful wearable device selection for the evolving clinical trials landscape
- Slide 20: Tufts Center, Medable: DCT Financial Net Benefit
- Slide 22: The Impact of Increased Technology Use on the Clinical Research Workforce
Talk Citation
Middleton, A. (2023, February 28). Introduction to decentralized clinical trials: benefits, challenges and solutions [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 11, 2024, from https://doi.org/10.69645/QRCL7486.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no commercial/financial matters to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
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.
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