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Session 2: Design and Conduct of COVID-19 Protocols – Implications for Efficacy and Safety
Session Chair(s)
Stephen Knowles, MD, MRCP
Chief Medical Officer
Halozyme Therapeutics, United States
The COVID-19 global pandemic has necessitated the rapid development, approval and conduct of clinical trials in order to address the urgent public health need for therapeutics and vaccines. The speed at which these programs has progressed is unprecedented. In this session, we will discuss the safety monitoring and safety endpoints in the trials; efficacy endpoints, including details of interim analyses; safety signal detection and risk management activities; Considerations for trial management between EUA/conditional marketing authorization and full approval and the role of the DSMB.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the design of clinical trials to answer the urgent questions of COVID-19 therapeutics and vaccines
- Understand the safety monitoring required for rapidly moving programs
- Understand the implications of early authorizations on ongoing studies and safety monitoring
Speaker(s)
SARS-CoV-2: From Pandemic Outbreak to Vaccine in 2020
Larry Smith, PHD
Consultant: COVID-19 Countermeasures, United States
Consultant
COVID-19 Vaccine Development
Peter W. Marks, MD, PHD
DIA Fellow, United States