The Importance of QT/QTc Prolongation: A Case Study

Many experts consider prolongation of the QT/QTc interval on an electrocardiogram to be a potential clinical biomarker for serious or even life-threatening adverse cardiac events. Awareness of drug-induced QT/QTc prolongation has increased over the last 10 to 15 years. The topic of this special section of the Drug Information Journal is drug-induced prolongation of the QT/QTc interval in clinical trials. Important regulatory, clinical, and statistical concepts in evaluating drug-induced QT/QTc prolongation are discussed. Most of the authors are members of the Pharmaceutical Research and Manufacturers of America (PhRMA) or E14 QT Statistics Expert Teams, or of the International Council on Harmonisation's E14 Working Group, which recently published the concept paper “The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs.” This issue of the Drug Information Journal provides a broad range of current scientific knowledge on this very timely and important topic. At Pfizer, in-house experts teach a QT interval workshop to their colleagues. The workshop is sponsored by the Global QT Advisory Council and facilitated by Learning and Development. For one colleague, the knowledge gathered at that workshop may have been the difference between life and death. The colleague has requested anonymity but thought it might be helpful to share the story in this issue of the Drug Information Journal.