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.