„Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes”, DIA 2018 Workshop

Contribution to Conference
Daumer M
This interactive workshop seeks to continue the recent discussions
on wearables and patient-focused outcomes in clinical trials. We will
discuss the applicability and suitability of mobile sensor technology to
various types of studies and the relevance of sensor-derived outcomes
to clinical decision-making. Physical activity, in particular walking,
plays a major role as a potential patient-oriented, sensor-derived
outcome measure in a broad range of diseases. Valid and reliable methods
to assess physical activity are currently developed and/or refined. One
example is the actibelt® system, which is a 3D accelerometer hidden in a
belt-buckle combined with a set of algorithms, that measures clinical
relevant outcomes such as walking speed in the real world. The
suitability of various devices will be discussed. Participants will be
encouraged to share their previous experience with wearables and/or
smartphone applications and discuss the current usage of mobile sensors
in clinical trials. The core part of the workshop will be a practical
session during which participants can wear different sensors and perform
various exercises that illustrate how the devices are used and what
data are generated (various walk and/or balance tests, normal activities
of daily living). Participants are encouraged to be creative and probe
the usability and applicability of this technology. The workshop will
finish with an interactive discussion on the regulatory aspects of
sensor-derived outcomes and their suitability as pivotal endpoints. This
can include a brainstorm on solutions to alleviate current shortfalls
in the clinical practice or to complement established endpoints,
depending on the application of interest. We aim to also discuss the
available and forthcoming evidence for the validity of sensor-derived
outcomes, which could wind up into a list of next steps to be taken
towards regulatory acceptance of these outcomes as pivotal endpoints in
clinical trials.
Learning Objective : Identify opportunities and
challenges of mobile sensor-technology as a method to assess physical
activity in clinical trials; Discuss the clinical relevance of candidate
endpoints derived from accelerometer data and discuss the usage of
sensor-derived outcomes as pivotal endpoints; Facilitate decisions on
the use of mobility sensors in their specific field of application.