Key Considerations: Incorporating
Digital Health Technologies into
Your Clinical Trial
Digital health technologies have the potential to
modernize the way clinical trials are conducted, and
to make them more informative and efficient for
sponsors and less burdensome for patients. From
including telemedicine visits into study protocols
to monitoring patients remotely through wearable
devices, digital health technologies are rapidly
changing clinical trial best practices.
A wide variety of digital health technologies,
including mobile phones, wearable devices, tablets,
personal digital assistants, sensors and computers,
can be used to support novel data collection in
clinical research. While planning your trial, be
sure to consider how these tools may improve your
study design:
+ + Collect patient-reported data through an
app or online: Using technology to administer
electronic patient reported outcomes* (clinically
validated scales that have been optimized for
administration on a smartphone, tablet or
computer) can gather information remotely and
provide insights into participants’ experiences
outside of the clinic.
+ + Collect novel datasets via wearable sensors:
Wearable sensors have the potential to provide
objective data about participants’ experiences
in and out of the clinic. This collection
method can gather massive amounts of data
at fine granularity and requires minimal
patient engagement.
+ + Conduct telemedicine visits: Instead of having
participants travel to the clinic for a study visit,
consider if evaluations can be done through
telemedicine to reduce patient and site burden.
+ + Send e-reminders through text message or
email: Automated reminders for participants
to complete certain protocol requirements,
such as taking medications or scheduling an
appointment, can improve compliance of
participants while introducing little burden
to sites.
Chapter 1
Key Takeaways
+ + Use the participant journey to map out successes, potential
challenges and areas for improvement in your clinical trial design.
+ + Involve key stakeholders early in the clinical trial design process to
enhance feasibility and acceptability by sites and participants.
+ + Consider ways in which technology could be incorporated into your
trial to enhance the participant experience.
*Underlined words indicate a commonly used term. Find the
definitions in the glossary, starting on page 42.
Chapter 1 — Clinical Research Design and the Participant Journey
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