Novartis Reply to the ATMOSPHERE Data Monitoring Committee

Autor: R. Paul Aftring, Gervais Tougas
Rok vydání: 2016
Předmět:
Zdroj: New England Journal of Medicine. 374:1586-1587
ISSN: 1533-4406
0028-4793
DOI: 10.1056/nejmc1603515
Popis: To the Editor: The Sounding Board article by Swedberg and colleagues,1 now published in the Journal, describes the experience of the data monitoring committee of the Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure (ATMOSPHERE) as data from other trials of aliskiren raised questions regarding a possible risk to participants in ATMOSPHERE.2 Novartis, as the sponsor of ATMOSPHERE, had engaged the independent data monitoring committee, which was composed of respected experts, to oversee the participants’ safety in this trial through periodic reviews of unblinded safety and efficacy data. During the course of the trial, the data monitoring committee, . . .
Databáze: OpenAIRE