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Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints
Session Chair(s)
Ebony Dashiell-Aje, PhD
Executive Director and Head, Patient Centered Outcomes Science
BioMarin, United States
This session will cover regulatory and research perspectives on challenges and opportunities for selecting, developing and implementing fit-for-purpose digital technology tools for to derive study endpoints to support drug development.
Learning Objective : Describe the regulatory and practical consideration for successfully selecting, developing, and implementing patient-focused digital technology tools for use to derive study endpoints (e.g., accelerometer or mobile technology derived endpoints) that are fit for purpose for use in clinical trials to support drug development.
Speaker(s)
What Can Technology-Derived Endpoint Tell us About the Patient’s Experience?
Jean Paty, PhD, MS
IQVIA, United States
Vice President, Patient-Centered Science
Fit-for-Purpose in the Digital Era: Digital Measurement Tools in Clinical Trials
Jennifer Goldsack, MA, MBA, MS
Digital Medicine Society (DiMe), United States
Chief Executive Officer
Fit-for-Purpose Digital Health Technology Driven Study Endpoints: Regulatory Considerations for Implementation
Ebony Dashiell-Aje, PhD
BioMarin, United States
Executive Director and Head, Patient Centered Outcomes Science
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