Online Program Home
  My Program

All Times EDT

Abstract Details

Activity Number: 428 - Design Considerations for COVID-19 Prevention Studies
Type: Invited
Date/Time: Thursday, August 12, 2021 : 4:00 PM to 5:50 PM
Sponsor: Biometrics Section
Abstract #316937
Title: Design of Non-Vaccine COVID-19 Prevention Studies
Author(s): Elizabeth Brown*
Companies: Fred Hutchinson Cancer Research Center

Response to the COVID-19 pandemic drove rapid implementation of innovative clinical trials for non-vaccine biomedical prevention of SARS-CoV-2 acquisition and progression to COVID-19 both for repurposed and novel biomedical interventions. Pre-Exposure Prophylactic (PrEP) and Post-Exposure Prophylactic (PEP) interventions have both been evaluated in an effort to find a non-vaccine biomedical intervention to stop the spread of SARS-CoV-2. Statistical design of these studies was challenging due to several factors, including lack of data on transmission risk, variability in demographics and geography over time leading to uncertainty in identifying high risk groups, potential contamination due to secondary intervention effects, uncertainty about the primary outcome and a potentially rapidly changing intervention landscape. In this presentation, we will review designs statistical properties of COVID-19 PrEP and PEP studies, exploring the approaches taken to overcome the challenges listed above.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2021 program