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Digital Technology in Clinical Trials

This event is now offered in a new entirely virtual format.

Session 6: Plenary: Meaningfulness of Technology-Driven Measures

Session Chair(s)

Paul  O'Donohoe, MS, MSc

Paul O'Donohoe, MS, MSc

  • Scientific Lead, eCOA and Mobile Health
  • Medidata Solutions, United States

With the ever expanding availability and capability of both medical and commercial-grade wearable devices and mobile sensors there has been a corresponding growth in interest in including them in clinical trials to collect data to provide additional insight into patient experience. However, while these technologies can measure a wide range of physical and biologic variables, their use can sometimes have the appearance of a solution in search of a problem. Extending the idea of “content validity” from the patient-reported outcome measure developmental literature, identifying what one is measuring with a sensor and, most importantly, what this means to the patient using it, is a vital step that is currently not fully appreciated within the pharmaceutical, sensor, and medical device industry.

This session will provide attendees guidance on how to establish content validity for mobile sensors and wearables and the importance of clearly defined ‘concepts of interest’ for establishing clinical trial endpoints. Firstly, a case study in chronic heart failure, where in depth work is being done with patients to identify meaningful outcomes that can be measured by a wearable device; secondly, a discussion of some of the lessons that can be learned from performance outcome (PerfO) assessments, where similar challenges in demonstrating content validity and identifying appropriate individual change metrics are present; and finally, an outline of how the industry can ensure the intentional development of these tools, which have so much potential, to properly integrate the patient experience in clinical trials in the future. Developing meaningful measures from wearable/mobile sensor technology is the necessary foundation to their use to derive clinical trial endpoints that are meaningful assessments of clinical benefit.

Learning Objective :
  • Understand the challenges/solutions, to identifying concepts meaningful to patients which are measurable with wearable devices and mobile sensors
  • Leverage some of the lessons learned during the development of PerfO assessments to wearable measure-driven outcomes
  • Identify a strategy for the long term and scalable integration of these technologies into clinical trials, ensuring that we are measuring concepts and deriving endpoints that are important to patients


Elizabeth (Nicki)  Bush, MHS

Meaningfulness of Technology-Driven Measures – What Can we Learn From Performance Outcome (PerfO) Assessments?

Elizabeth (Nicki) Bush, MHS

  • Senior Advisor and Head, Patient-Focused Outcomes Center of Expertise
  • Eli Lilly and Company, United States
Bill  Byrom, PhD

Endpoint Development Using Mobile Sensor Data

Bill Byrom, PhD

  • Vice President, Product Intelligence and Positioning
  • Signant Health , United Kingdom
Sonya  Eremenco, MA

Determining Meaningfulness of Activity Monitor Measures from the Patient’s Perspective

Sonya Eremenco, MA

  • Associate Director, PRO Consortium, and Acting Director, ePRO Consortium
  • Critical Path Institute, United States