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Real-World Evidence Conference

Translating Insights into Real-World Value.

Session 7: Leveraging COVID-19 Learnings to Transform Clinical Trials using RWE

Session Chair(s)

Mark Stewart, PhD

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)

Jeff Elton, PhD, MBA

Oncology RWE in a Post COVID World

Jeff Elton, PhD, MBA

  • Chief Executive Officer
  • ConcertAI, United States
Donna Rivera, PharmD, MSc

Seeing Opportunity through Challenge: Pragmatic Approaches to Evidence Generation

Donna Rivera, PharmD, MSc

  • Associate Director for Pharmacoepidemiology, RWD and RWE, OCE
  • FDA, United States
Matthew T Roe, MD, MHS

Using Real World Data and Technology to Transform Clinical Trials

Matthew T Roe, MD, MHS

  • Chief Medical Officer
  • Verana Health, United States

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Preconference Short Courses

Short Course 1: The Evolving Landscape of Real-World Data (RWD) and the Use of Pharmacoepidemiologic Methods and Machine Learning to Generate Credible Real-World Evidence (RWE)

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