Data Management of Emergency use Antiarrhythmic Clinical Trials

AbstractThe main purpose of an Antiarrhythmic Emergency Use clinical trial is to provide alternative treatment to patients who manifest life-threatening arrhythmias and who are intolerant or refractory to marketed drugs. Such large scale, open-labelled programs involve heterogeneous patient populations without comparable control groups. This paper will discuss problems associated with the research practices and suggest an approach to manage and analyze data from Antiarrhythmic Emergency Use clinical trials.