SEPTEMBER 29, 2016 TO SEPTEMBER 30, 2016

CTTI Project: Developing Novel Endpoints

Meeting Objectives

Identify how to develop novel endpoints for use in clinical trials by writing the following use cases:

• Parkinson’s Disease: Physical activity level and gait, measured using an accelerometer, as an endpoint for Parkinson's disease
• Heart Failure: Physical activity level, measured using an accelerometer, as an endpoint for heart failure
• Diabetes: Blood sugar level, measured using a wearable continuous glucose monitor, as an endpoint for diabetes
• Muscular Dystrophy: Physical activity level, measured using

Meeting Location:

DoubleTree Silver Spring Hotel by Hilton, 8727 Colesville Rd, Silver Spring, Maryland

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations

1. Mobile in Clinical Trials: Developing Novel Endpoints for use in Clinical Trials by Jennifer Goldsack
2. Clinical Trial Endpoints from Mobile Technology: Regulatory Considerations by Elektra J. Papadopoulos
3. Assessing and Supporting Outcome AssessmentsCategories, Context, and Evidence: Mobile Technology Novel Endpoints Workshop by Marc K. Walton
4. Performance Outcome Assessments: Identifying Endpoints that are Meaningful and Measurable by Stephen Joel Coons
5. Developing Performance Outcome Measures for Use with Regulatory Agencies: The Aging In Motion (AIM) Coalition Experience by Cynthia A. Bens
6. Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials: The Use Case Approach by Jennifer Goldsack