Organization of Clinical Trials: Problems, Controversies, Definitions, Methodology

Abstract

In internal medicine, there are two disciplies in which patients are treated with curative intent - infectious disease and medical oncology. Systemic drug therapy is the cornerstone of curative treatment in both disciplines. In both areas there has been an explosion in the number of agents employed, a broadening of the types of agents available, as well as an increase in the spectrum of activity and toxicity associated with their use. With the widespread use of cytotoxic agents, treatment algorithms were required to deal with the intense, often sustained iatrogenic induction of granulocytopenia integral to the appropriate therapy of a variety of cancers. All of these historic developments have led to a welding of the activities of the infectious disease and medical oncology subspecialist.