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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?
Vice President, Patient-Centered Science, IQVIA, United States
Fit-for-Purpose in the Digital Era: Digital Measurement Tools in Clinical Trials
Chief Executive Officer, Digital Medicine Society (DiMe), United States
Fit-for-Purpose Digital Health Technology Driven Study Endpoints: Regulatory Considerations for Implementation
Executive Director and Head, Patient Centered Outcomes Science, BioMarin, United States
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