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DIA 2021 Global Annual Meeting
Remote Implementation of Clinical Outcome Assessments During the COVID-19 Pandemic and Beyond
Elektra Papadopoulos, MD, MPH
- Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER
- FDA, United States
Remote clinical outcome assessments (COAs) enable conduct of decentralized trials and played a pivotal role in adapting trials during the COVID-19 pandemic. A multi-stakeholder panel will discuss considerations for implementing COAs remotely.
Learning Objective : Describe considerations for remote implementation of COAs during and after COVID-19; Discuss opportunities and challenges to implement remote COAs in clinical trials; Discuss key aspects of data collection and analysis when using remote COAs.
Isaac R Rodriguez-Chavez, MHS, PhD, MS
- Senior Vice President, Scientific and Clinical Affairs, Head, Global COE
- ICON plc, United States
Maria Tome, MD, PhD, FFPM
- Pharma Medicine Physician, Senior Scientific Advisor, Scientific Advice
- European Medicines Agency, Netherlands
- Senior Director, Strategy and Innovation, Global Regulatory Policy
- Janssen, Spain