APR May/June 2023 - 45

« FORMULATION AND DEVELOPMENT
Recognizing the burden for site staff to adapt to work in different and
sometimes altogether new ways compared to their tried-and-true
processes, it is critical to consider all facets of the site's experience
with the trial during the design stages. Every new piece of technology
and process change holds the potential to compound the complexity
for sites. If sites don't readily adapt, the result could be slower trial
timelines, lower data quality, higher staff burnout and disengagement
from the trial.
Thus, the details of how systems interconnect (for example, minimizing
the number of platforms and data entry requirements by integrating
DCT systems) will directly impact the time required by site staff to
work on a DCT. The fewer platforms used and the use of integrations
(for example, from an eConsent platform to the EDC) will reduce the
time and burden for the site staff working on the study. Therefore, it
is critical that, as part of the DCT strategy, understanding how sites
interact with each platform is placed at the forefront of consideration
during design.
Increased operational complexity at the sites is also an example
of why an FSP engagement is an ideal outsourcing model for DCTs.
Specialized expertise can be added through an FSP model to ease
the site burden by providing support services and training to fill site
capabilities/resource gaps and keep the study on schedule (e.g., by
adding FSP-sourced site study coordinator roles or administrative
support services).
Mapping out precisely how the site will interact with the different
tools in a logical order, as illustrated in Figure 3, with a value placed
on integration to avoid duplicate data entry, can go a long way to help
reduce site burden.
With integration, data from one source can become the truth for all
sources, eliminating the need for duplicate entry or integration of data
and to reconcile it across systems. Without this interconnectivity, sites
would need to use multiple platforms, potentially frustrating users.
In addition to avoiding redundant data entry through the integration
of systems wherever possible, DCT data management designs also
should strive for simplicity to minimize the number of vendors and
DCT platforms, ensure that an agile change management process is
in place, and provide clear training and support for site staff. Aroundthe-clock
and multilingual service desk support to cover unexpected
issues from the patients and sites is also often helpful.
Finally, proactive risk mitigation strategies should be incorporated to
help sites gain comfort with a model, processes and technologies that
were not part of their norm. As an example, the primary endpoint for
a trial could be eDiary data that are then compared at baseline to a
critical window during the treatment period. If a patient is completing
an eDiary daily, a review of compliance could be performed across
sites with outliers flagged for sites to remind patients of their
commitments. Also, during the critical period, missed entries could
be escalated for more prompt support to ensure compliance does not
drop significantly, thus helping to protect the endpoint.
Decision Point #4: Optimizing
the Data Journey
When designing a DCT strategy, the design must fit the needs both
of patients and sites. It also needs to be able to collect and deliver all
the data required to meet the primary and secondary endpoints for
the study, so, the asset is more likely to be approved by regulatory
agencies, wanted by patients, prescribed by physicians, and covered
by payers at a price in line with the value it provides.
Figure 3. Example of a DCT flow highlighting a site's interactions with different systems
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APR May/June 2023

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