In this session, we review the use of mobile and sensor technology and its application in clinical research. Considering a 2000 subject case study, we appraise the use of mobile solutions to collect field-based patient-reported outcomes and patient engagement in a one year clinical trial. We look to the capabilities of modern technology solutions in leveraging the measurement of new health outcomes and trial endpoints. Considering the technology inherent in gaming platforms we appraise its capability to measure objective performance outcomes in non-specialist clinic settings. Finally, we explore app-based performance tests leveraging in-built smartphone sensors to provide frequent measures of aspects of symptomatology in Parkinson’s disease from the home setting. We consider how these approaches may lead to robust future endpoints to inform drug development and regulatory submissions.
Learning Objective : 1. Describe the use of subject electronic diaries for evaluation of primary efficacy and safety endpoints in a Phase 3 contraceptive patch trial. 2. Discuss the role of mobile devices and text messaging in facilitation of subject compliance with study drug and clinic visits. 3. Compare and contrast the challenges, advantages and disadvantages of electronic versus paper diary data collection.
Use of an Electronic Diary to Capture Subject-Reported Data for the Evaluation of Primary and Secondary Endpoints
Elizabeth Garner, MD, MPH
Chief Medical Officer, Senior Vice President of Clinical Development
Agile Therapeutics, United States
Game On: Leveraging Video Game Platforms to Measure Clinical Endpoints
Bill Byrom, PhD
Vice President, Product Strategy and Innovation
CRF Health , United Kingdom
Digital Biomarkers: Towards Modernized Endpoints
Christian Gossens, PhD
Global Head, Early Development Workflows
F. Hoffmann-La Roche Ltd., Switzerland