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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

Session 2: Statistical, Regulatory, and Operational Considerations for the Use of Digital Health Technologies and Endpoints in Clinical Trials

Session Chair(s)

Jonathan  Haddad, MPH

Jonathan Haddad, MPH

  • HIV Disease Area Head, Clinical Statistics
  • GlaxoSmithKline, United States
Scott  Komo, DrPH

Scott Komo, DrPH

  • Lead Mathematical Statistician, Office of Translational Sciences, CDER
  • FDA, United States
This session will briefly review the digital health technology landscape as it pertains to clinical trials. Examples of where digital health technology data/endpoints are incorporated in clinical trials and the statistical, regulatory, and operational considerations will be presented. Representatives from Working Groups in this space will discuss key challenges and next steps to realize greater integration of digital data (the future).
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Understand the potential uses of digital health technologies in drug development
  • Gain awareness of key statistical and regulatory challenges with developing and analyzing digital health technology endpoint in clinical trials
  • Gain of awareness of key logistical and operational challenges in using digital health technologies in clinical trials


Andrew  Potter, PhD

Missing Data and Other Statistical Considerations for Wearable Activity Monitors in Clinical Trials

Andrew Potter, PhD

  • Mathematical Statistician, OB, OTS, CDER
  • FDA, United States
Luis  Garcia-Gancedo, PhD

Digital Health Technology Tools in Clinical Trials: Challenges and Opportunities

Luis Garcia-Gancedo, PhD

  • Director, Digital Biomarkers
  • GSK, United Kingdom
Tyler  Reynolds

Considerations for Operationalizing Digital Health Technologies

Tyler Reynolds

  • Digital Health Consultant
  • PA Consulting, United States

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Additional Information

Biostatistics Industry Resource Kit