The Adaptive COVID-19 Treatment Trial-1 (ACTT-1) in a real-world population: a comparative observational study
Matilde Grupe Frost, Espen Jimenez‐Solem, Mikkel Zöllner Ankarfeldt, Martin Erik Nyeland, Anne Helms Andreasen, Tonny Studsgaard Petersen
Abstract
The recently published ‘Adaptive COVID-19 Treatment Trial’ (ACTT-1) showed that remdesivir is a promising treatment option against coronavirus disease 2019 (COVID-19) [ 1 ]. Consequently, remdesivir is now being evaluated for implementation in clinical practice worldwide. Randomized clinical trials (RCTs) are the current golden standard for procuring evidence of a drug’s efficacy, but in order to predict effectiveness and safety in daily clinical practice, it is important to complement the results from RCTs with an evaluation of their transferability to a real-world setting. To bridge the evidentiary gap between clinical research and clinical practice, the U.S. Food and Drug Administration recognizes the need for harnessing ‘Real-World Data’ and observational methods to generate evidence of effectiveness to support regulatory decisions concerning drugs [ 2 ]. The aim of the present study was to examine whether the evidence generated in the ACTT-1 could be applied to a real-world population by comparing characteristics of the included patients and their outcomes in order to evaluate the transferability of the trial’s outcomes to the patients eligible for remdesivir treatment in clinical practice.