Highlights the tension between regulatory authorities and Data Monitoring Committees regarding patient safety interventions during ongoing clinical trials.
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.
Swedberg et al. (Mon,) studied this question.
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