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Session 7: Leveraging COVID-19 Learnings to Transform Clinical Trials using RWE
Session Chair(s)
Mark Stewart, PhD
Vice President, Science Policy
Friends of Cancer Research, United States
The COVID-19 pandemic presented unique issues managing clinical trials and exacerbated routinely encountered challenges with patient enrollment, patient access, and complex trial designs. This led to the necessity to modify clinical trials and increased uptake of real-world evidence (RWE) to address these challenges. This session will highlight applications of RWE to optimize clinical trial processes, outline regulatory actions to support these uses, and characterize opportunities to translate learnings from the COVID-19 pandemic into sustainable methods for future clinical trials.
Learning Objective : At the conclusion of this session, participants should be able to:
- Define the expanding applications of RWE to support clinical trials and evidence generation
- Discuss efforts to support high quality research using RWD/E
- Translate lessons from COVID-19 into actionable opportunities for future clinical trials
Speaker(s)
Oncology RWE in a Post COVID World
Jeff Elton, PhD, MBA
ConcertAI, United States
Chief Executive Officer
Seeing Opportunity through Challenge: Pragmatic Approaches to Evidence Generation
Donna Rivera, PharmD, MSc
FDA, United States
Associate Director for Pharmacoepidemiology, OCE
Using Real World Data and Technology to Transform Clinical Trials
Matthew T Roe, MD, MHS
Verana Health, United States
Chief Medical Officer