Esketamine clinical trials: reply to Maju et al.

Chiara GastaldonD PapolaGiovanni Ostuzzi Corrado Barbui

Published in: Epidemiology and psychiatric sciences (2020)

Maju et al. provided clarifications on important and controversial issues related to esketamine clinical trial data, in response to a vivid debate triggered by the marketing authorisation recently granted by this new medicine. In this commentary, we reply to their comments attempting to critically discuss the evidence base needed to obtain regulatory approval.

Keyphrases

clinical trial
phase ii
electronic health record
open label
transcription factor
double blind
study protocol
phase iii
big data
drug administration
randomized controlled trial