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Monday, June 25 • 3:00pm - 4:15pm
#142: Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-540-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Martin Daumer, DrSc

Speaker

Facilitator
Bill Byrom, PhD

Facilitator
Bernd Grimm, PhD

Facilitator
Kate Lyden, PhD



Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health
Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
avatar for Martin Daumer

Martin Daumer

Scientific Director, Sylvia Lawry Centre For Multiple Sclerosis Research - The Human Motion Institute
Dr Martin Daumer: Director of the SLCMSR e.V. - The Human Motion Institute in Munich and managing director of the IT company, Trium Analysis Online GmbH. He is also Honorary Professor for Telemedicine and Clinical Applications of Computational Medicine at the Technical University... Read More →
avatar for Bernd Grimm

Bernd Grimm

Senior Engineer, Sylvia Lawry Centre, The Human Motion Institute
As a former lecturer of Applied Mechanics at Bath University, UK and biomedical engineer for implant design, Dr. Bernd Grimm directed the orthopaedic research foundation and coordinated clinical research at Zuyderland, training hospital of Maastricht University NL. Since 2004 he's... Read More →
avatar for Kate Lyden

Kate Lyden

Clinical Research Scientist, PAL Technologies Ltd.
Kate Lyden is a research scientist with an expertise in measuring physical behavior with wearable sensors. Kate works as part of the research & development team for PALTechnologies and serves as Adjunct Faculty to the Kinesiology Department at The University of Massachusetts. Kate’s... Read More →


Monday June 25, 2018 3:00pm - 4:15pm
Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA