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Medicare change-of-heart over ICD data

This article was originally published in The Gray Sheet

Executive Summary

CMS will not seek access to interim data from NIH's Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), despite earlier plans to meet with agency to determine why the study's data safety monitoring board opted to allow patients to continue in the placebo arm (1"The Gray Sheet" March 31, 2003, p. 3). According to the Centers for Medicare & Medicaid Services, access to the interim data would jeopardize the blinded nature of the study and ultimately would be less relevant than the trial's complete results, expected by 2004. CMS instead will try to achieve detailed knowledge of SCD-HeFT patient characteristics and learn from NIH which factors led the DSMB to make its decision...

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