Biotechnology in the Time of COVID-19: Commentaries from the Front Line

by Jeremy M. Levin

What are the impacts of these risk/benefit decisions on the applicability of the resultant data to current or future patients in those other population segments? – Where in the disease progression is an experimental medical countermeasure best developed? For example, should the target patient population include only critically ill patients, those recently infected, or individuals who have never been exposed? – At what stage in the clinical or preclinical development process can a medical countermeasure be administered to humans?4 For example, is it acceptable for critically ill patients to be given compounds not yet tested in humans? What about individuals who were recently infected, or individuals who have never been exposed? – What inclusion and exclusion criteria should be established for clinical testing? For example, in addition to disease status and patient prognosis, what are the criteria for comorbid conditions, concomitant medications, age, or gender? How do companies balance the demands of social justice, developing interventions that are useful for the broadest patient populations, with the time and resource constraints and the overarching societal demand for rapid clinical development? Can clinical trials be randomized and placebo-controlled when the standard of care might lead to death, or should they be open-label? How does this affect the evaluation of potential endpoints and the decisions regarding clinical trial event rates for these endpoints? – As the nu...