In Harch of 1980, we organized the first symposium on how to evaluate new antiarrhythmic agents in which the participants included members of the Cardio-Renal Division of the Food and Drug Administration, academic investigators from the United States and Abroad and directors and imple mentors of pharmacological research representing the pharmaceutical industry. By bringing together all three elements, it was hoped that better communication and under standing would ensue to more rapidly bring new cardiac agents to the American public. This goal was important since a rather limited number of antiarrhythmic agents were and are currently available to treat patients with such disorders in the United States. These agents are needed not only for the treatment of patients with sustained ventricular tachyarrhythmias which produce life-threatening hemodynamic consequences but also and in fact more potentially important as a prophylactic measure in the high risk patient subject to sudden cardiac death. This book represents the proceedings of the third of these Symposiums whose purpose was to evaluate the clinical research methodology and models used in the evaluation of ne" antiarrhythmic agents for not only acute therapeutic inter vention but also for the prophylaxis of sudden cardiac death. In addition, new devices have evolved over the past few years that can detect and treat life-threatening cardiac arrhythmias and the evaluation of efficacy and safety of these devices is detailed."

It is generally easy to define the efficacy of a new the- peutic agent. However, what is even more difficult and more challenging yet more important is to define its safety when administered to millions of patients with multi-faceted d- eases, co-morbidities, sensitivities and concomitant medi- tions. The commonest cause of new drug discontinuations, cause for disapproval from marketing and removal from the market after approval is a drug's effect on cardiac repolari- tion which is essentially identified by increasing the duration of the QTc interval duration on the standard 12-lead elect- cardiogram (ECG). Cardiac Safety of Noncardiac Drugs: Practical Guide- Joel Morganroth, MD lines for Clinical Research and Drug Development is designed to present the current preclinical, clinical, and re- latory principles to assess the cardiac safety of new drugs based primarily on their effects on the ECG. Practical gu- ance to define cardiac safety at all stages of clinical research and drug development are featured and discussed by inter- tionally recognized experts with academic, industrial, and regulatory experience. Each chapter contains the best ava- able evidence, the author's personal opinions, areas of c- troversy, and future trends. Although some of the areas are highly specialized, this book has been designed for a broad audience ranging from medical and graduate students to cli- cal nurses, clinical trial coordinators, safety officers, data managers, statisticians, regulatory authorities, clinicians, and Ihor Gussak, MD, PhD scientists.