 Boaz Mendzelevski, MD Medifacts International Vice President of Cardiology & Chief Medical Officer Visit Website |
Dr. Mendzelevski received his degree in Medicine and Board Certification in Internal Medicine from the Ben-Gurion University Medical School and Hospital in Beer-Sheva, Israel. He then trained in cardiology and received a board certification in Cardiology from the Shaare-Zedek Medical Centre and Hebrew University in Jerusalem, Israel. Dr. Mendzelevski completed further postgraduate training in Interventional Cardiology and Clinical Electrophysiology at the Royal Brompton National Heart and Lung Hospital in London.
Dr. Mendzelevski has authored approximately 220 cardiology expert reports, most of which supported NDA regulatory submissions. He has represented pharma clients before the US FDA and the European regulatory authorities on several occasions and has participated in multiple pharmaceutical advisory boards and Data Safety Monitoring Boards (DSMBs). Dr. Mendzelevski was the only CRO expert to be invited by the FDA and ICH to serve on the ICH-E14 expert advisory panel.
|
Cardiac Safety Q&A
-
With evidence showing that women are at a higher risk than men for proarrhythmias linked with QTc prolongation, should the issue of gender receive more consideration when enrolling through QT studies?Answered April 15th, 2010 by Expert:The ICH-E14 guidance does indeed call for an “adequate representation” of female subjects in clinical trials, although not specifically for the Thorough QT (TQT) study. However, most TQT studies follow this recommendation and enroll sufficient numbers of female subjects. Interestingly, the issue of enrolling subjects with higher sensitivity to drug-induced QT prolongation and arrhythmia in TQT studies has been widely debated. Some also suggested that TQT studies with male-only subjects would reduce the well-known physiological variability in the QT interval and would therefore make these studies more efficient, requiring less subjects to meet the primary endpoint with sufficient statistical power. Nevertheless, the practice of “male-only” TQT studies has not been taken up and most TQT studies aim at enrolling equal proportion of male and female subjects.
Leave a reply