APR May/June 2023 - 42

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FORMULATION AND DEVELOPMENT
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Building a Strong
Data Foundation for
Decentralized Clinical Trials
with an FSP Model
Robert King
Executive Director, Functional Service Partnership (FSP) Solutions
PPD Clinical Research Business of Thermo Fisher Scientific
Jenna McDonnell
Senior Director, Consulting,Innovation and Strategy, Digital and Decentralized Solutions
PPD Clinical Research Business of Thermo Fisher Scientific
George Weir
Senior Director, Clinical Data Management
PPD Clinical Research Business of Thermo Fisher Scientific
By bringing trials directly to patients, decentralized clinical trials
(DCTs) offer a host of compelling benefits, including reduced patient
burden, such as travel and financial obligations, making it easier for
patients to participate in clinical trials, which, in turn, results in faster
recruitment, more diversity and increased retention. DCTs also can
include environmental benefits through less travel and paper-based
processes, which can help reduce the carbon footprint of the trial.
However, previously, perceived or actual regulatory or ethics
committee hurdles, operational complexities - including significant
data-handling challenges - and a lack of willingness to try something
novel have slowed the adoption of DCTs.
Then came COVID-19. By necessity, DCTs were rapidly adopted across
therapeutic areas as a means to allow clinical trials to continue, with
advancements and accelerations in digital technologies serving as
a key enabler. During the pandemic, developers gained significant
experience in the appropriate application of DCTs, strategies that are
now taking greater hold. In a survey conducted by the PPD clinical
research group of Thermo Fisher Scientific in 2022, current users of
DCTs anticipated that upwards of 40% of their trials will employ DCT
strategies by 2024, as compared to 20% only a year prior.1
Though industry terminology has yet to be standardized, DCTs can
be defined as clinical trials that include the flexibility for patients to
participate in a trial remotely for some or all of a trial. While some
trials are entirely virtual, the vast majority of DCTs include a mix of
visits in the home and/or in the community and/or at a traditional
investigational site.
DCTs can provide greater efficiency and reduce patient burden, but
they're not formulaic. A wide range of decentralized elements (e.g.,
home health visits, televisits and remote monitoring) and technologies
(e.g., electronic consent, wearables, electronic clinical outcome
assessments and more) may be selected within the DCT spectrum, as
illustrated in Figure 1.
DCTs may be well understood as a concept, however, their
implementation is still relatively new within the industry. Given that
DCTs also entail a significant lift in data complexity and volume, the
traditional data management operating models need to evolve so
they are less reactive and, instead, engage at the pre-protocol design
stage, focused on proactive planning and the application of risk-based
quality management methodologies.
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| May/June 2023
APR May/June 2023

Table of Contents for the Digital Edition of APR May/June 2023
