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Session 2: Impact of COVID-19 on Clinical Trials
Session Chair(s)
Lisa Renee Bailey Iacona, PhD, MPH
Vice President, Oncology Biometrics
AstraZeneca Pharmaceuticals LP, United States
Fairouz Makhlouf, PhD
Deputy Director, Office of Biostatistics, Office of Translational Science, 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)
An Enterprise Approach to Handle the Impact of COVID-19 Pandemic on Clinical Trials
Yihua Gu, MS
Abbvie, United States
Senior Director of Statistics, Immunology TA Head
Speaker
Martin Klein, PhD, MS
FDA, United States
Mathematical Statistician, CDER
Addressing the Impact of the COVID-19 Pandemic on Survival Outcomes in Randomized Phase III Oncology Trials
Binbing Yu, PhD
Astrazeneca, United States
Statistical Science Director, Head of Statistical Innovation
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