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Clinical Trials in Public Health Emergencies: the Ebola and COVID Experiences
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Clinical Trials in Public Health Emergencies: the Ebola and COVID Experiences
Air date: Wednesday, May 13, 2020, 3:00:00 PM
Category: COVID-19
Runtime: 00:57:48
Description: NIH COVID-19 SIG Lecture Series
Designing and implementing clinical trials for novel infectious disease treatments brings many challenges, especially during a rapidly evolving pandemic. A new disease brings uncertainties arising from an imperfect understanding about illness, limited information about proposed countermeasures, and complexities in measuring relevant patient outcomes. A pandemic adds an overloaded medical system with limited resources for research, heightened pressure to find cures quickly, and unpredictability about potential case numbers. I will discuss issues related to designing and conducting treatment trials in outbreaks of Ebola and COVID based on my experience with three studies: Prevail II (the West African Ebola virus disease study of ZMapp), PALM (the Democratic Republic of the Congo Ebola virus disease study of ZMapp, mAb114, REGN-EB3 and remdesivir) and ACTT-1 (the multinational, platform COVID-19 study of remdesivir vs placebo).
Author: Lori Dodd, Ph.D., Mathematical Statistician, Biostatistics Research Branch, Division of Clinical Research, NIAID, NIH
Air date: Wednesday, May 13, 2020, 3:00:00 PM
Category: COVID-19
Runtime: 00:57:48
Description: NIH COVID-19 SIG Lecture Series
Designing and implementing clinical trials for novel infectious disease treatments brings many challenges, especially during a rapidly evolving pandemic. A new disease brings uncertainties arising from an imperfect understanding about illness, limited information about proposed countermeasures, and complexities in measuring relevant patient outcomes. A pandemic adds an overloaded medical system with limited resources for research, heightened pressure to find cures quickly, and unpredictability about potential case numbers. I will discuss issues related to designing and conducting treatment trials in outbreaks of Ebola and COVID based on my experience with three studies: Prevail II (the West African Ebola virus disease study of ZMapp), PALM (the Democratic Republic of the Congo Ebola virus disease study of ZMapp, mAb114, REGN-EB3 and remdesivir) and ACTT-1 (the multinational, platform COVID-19 study of remdesivir vs placebo).
Author: Lori Dodd, Ph.D., Mathematical Statistician, Biostatistics Research Branch, Division of Clinical Research, NIAID, NIH
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