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Challenges to Data Monitoring Committees When Regulatory Authorities Intervene

2016; Massachusetts Medical Society; Volume: 374; Issue: 16 Linguagem: Inglês

10.1056/nejmsb1601674

1533-4406

Karl Swedberg, Jeffrey Borer, Bertram Pitt, Stuart J. Pocock, Jean L. Rouleau,

Health Systems, Economic Evaluations, Quality of Life

During ATMOSPHERE, a trial comparing aliskiren, enalapril, or both for heart failure, two other trials suggested harm from aliskiren in patients with diabetes, and regulators stopped aliskiren in such patients in ATMOSPHERE. The data monitoring committee suggests that regulators should trust the DMC to ensure patient safety in a clinical trial. The trial sponsor (Novartis) and the regulatory agencies have responded in letters to the editor.