Medicare change-of-heart over ICD data
This article was originally published in The Gray Sheet
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...
You may also be interested in...
CMS will contact the National Heart, Lung & Blood Institute within the next two weeks to try to determine why SCD-HeFT study patients who met the MADIT-II trial criteria were not switched to the active ICD treatment arm
Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.
Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.