Regulatory Reply to the ATMOSPHERE Data Monitoring Committee

Abstract

To the Editor: We agree with Swedberg et al.,(1) whose Sounding Board article is now published in the Journal, regarding the role and responsibilities of the data monitoring committee. We also agree that the data monitoring committee should be allowed to act independently during the progress of a trial. The committee's role is to provide continuous safety monitoring of the trial and to make recommendations on further trial conduct.(2) Regulators such as the European Medicines Agency (EMA) must also act in line with their responsibilities regarding the safety of medicines. It is their role to continuously review any new information . . .