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DIA/FDA Biostatistics Industry and Regulator Forum

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


Session 2: Impact of COVID-19 on Clinical Trials

Session Chair(s)

Lisa Renee Bailey Iacona, PhD, MPH

Lisa Renee Bailey Iacona, PhD, MPH

  • Vice President, Oncology Biometrics
  • AstraZeneca Pharmaceuticals LP, United States
Fairouz  Makhlouf, PhD

Fairouz Makhlouf, PhD

  • Mathematical Statisticain, CDER
  • FDA, United States
The COVID-19 pandemic may have affected the ability for patients and physicians to follow standard of care procedures and visits. Medical care saw increased use of home health/telemedicine and greater potential for missed in-person visits and tests. This session will highlight how this impact on clinical trials has been assessed through the use of modelling and simulation, case studies and regulatory guidance.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss how modelling and simulation can address potential scenarios seen during COVID-19
  • Describe some of the issues of missing data using examples and suggest ways to address
  • Explain the FDA perspective on the new Guidance “Conduct of Clinical Trials During COVID-19” and their experience to date

    Speaker(s)

    Yihua  Gu, MS

    An Enterprise Approach to Handle the Impact of COVID-19 Pandemic on Clinical Trials

    Yihua Gu, MS

    • Senior Director of Statistics, Immunology TA Head
    • Abbvie, United States
    Martin  Klein, PhD, MS

    Speaker

    Martin Klein, PhD, MS

    • Mathematical Statistician, CDER
    • FDA, United States
    Binbing  Yu, PhD

    Addressing the Impact of the COVID-19 Pandemic on Survival Outcomes in Randomized Phase III Oncology Trials

    Binbing Yu, PhD

    • Statistical Science Director, Head of Statistical Innovation
    • Astrazeneca, United States