Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports.

Rosemarie D L C BernabeG J M W van ThielN S BreekveldtC C Gispen-de WiedJ J M van Delden

Published in: Current medical research and opinion (2018)

Regulators regularly encounter ERFs that at least "might adversely affect the rights, safety or well-being of the subjects". It remains to be explored how regulators respond to these ethical issues.

Keyphrases

clinical trial
transcription factor
public health
big data
open label
phase ii
study protocol
double blind
decision making
emergency department
randomized controlled trial
global health
phase iii
placebo controlled