Kleintje66 schreef op 25 februari 2021 10:42:
[...]
Dat kan maar de FDA noemt een aantal optie's.
NeuroRX: " yesterday the FDA published formal guidance† changing the required time for measuring the prespecified endpoint of "alive and free of respiratory failure" in critically ill patients to 60 days."
FDA: In a trial in severe and/or critically ill patients, examples of appropriate endpointscould be
- All-cause mortality at an appropriate time point (e.g., at least 28 days for hospitalized noncritically ill patients,27 60 days for critically ill pat ients28)
-Proportion of patients alive and free of respiratory failure at an appropriate timepoint (e.g., at least 28 days for hospitalized noncritically ill pat ients, 60 days for crit ically ill patients)
-Clinical status using an ordinal scale that incorporates multiple clinical outcomes of interest (e.g., death, mechanical ventilation) ordered by their clinical importance at an appropriate time point (e.g., at least 28 days for hospitalized noncritically ill pat ients, 60 days for critically ill patients)29
-First occurrence of any component of a composite endpoint of symptomatic deep-vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortalit y by an appropriate time point
-Time to sustained recovery assessed over an appropriate duration
De copy past geeft een wat verwarrende opmaak en cijfers die de FDA gebruikt als verwijzing naar een onderzoek.