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Wednesday, June 26 • 4:15pm - 5:30pm
#390: Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-709-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Ebony Dashiell-Aje, PhD

Speaker

What Can Technology-Derived Endpoint Tell us About the Patient’s Experience?
Jean Paty, PhD

Fit-for-Purpose in the Digital Era: Digital Measurement Tools in Clinical Trials
Jennifer Goldsack, MA, MBA, MS

Fit-for-Purpose Digital Health Technology Driven Study Endpoints: Regulatory Considerations for Implementation
Ebony Dashiell-Aje, PhD



Speakers
avatar for Ebony Dashiell-Aje

Ebony Dashiell-Aje

Clinical Outcome Assessments Reviewer, COA Staff, OND, CDER, FDA
Dr. Dashiell-Aje is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Center for Drug Evaluation and Research (CDER) at the FDA. She serves as an expert consultant to CDER and other FDA Centers (e.g., CDRH, CBER), advising on COAs, study endpoint issues and regulatory... Read More →
avatar for Jennifer Goldsack

Jennifer Goldsack

Interim Executive Director, Digital Medicine Society (DiMe)
Jen Goldsack is the Interim Executive Director of the Digital Medicine (DiMe) Society and is Vice President of Digital Measurement at monARC Bionetworks.
avatar for Jean Paty

Jean Paty

Vice President, Patient-Centered Endpoints, IQVIA
Dr. Paty is an acknowledged leader in the effective strategies and practices of capturing patient perspective data for use in the clinical development of new medical products. He has published extensively in the areas of Patient Reported Outcomes (PRO) and electronic PRO (ePRO), as... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Patient Focused,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session