ABSTRACT

A clinical trial is a research study involving human subjects and an intervention (i.e., device, drug, surgical procedure, or other procedure) that is ultimately intended to either enhance the professional capabilities of physicians (i.e., improve the service delivered), improve the quality of life of patients, or contribute to the eld of knowledge in those sciences which are traditionally in the medical eld setting-for example, physiology, anatomy, pharmacology, epidemiology, neurology, cognitive psychology, etc. (Levin, 1986). Clinical trials research is in the business of evaluating therapeutic interventions intended to benet humans. Its value is directly related to the relevance of the questions “Do our treatments work?” “How well do our treatments work?” and “Are our treatments safe?” For example, drug A is designed and anticipated to relieve sinus congestion. Is there a drug interaction when drug A is taken with drug B and/or moderate levels of alcohol consumption such that while congestion is relieved (i.e., drug A is eective), human information processing capacities are reduced (i.e., is drug A safe?). And what is the time course of eects with regard to positive and negative (or adverse) eects? us it is clear that not only steady-state issues buy also dynamic questions are on interest in clinical trials research.