Duration of the Disease

The duration of the disease to be investigated with a new compound affects the timing of the investigation. The normal investigative period involved in attaining FDA approval consists of four phases of study (Phases I through IV clinical trials). If a disease is acute and short-lived, pediatric patients are usually studied during Phases I and II. When the disease is chronic, however, pediatric trials are usually not initiated until Phase III or Phase IV. Some drugs, such as psychoactive compounds, must be administered to children over many months or years. In such cases, special preclinical tests should be completed before the initiation of pediatric trials. Such studies would include animal studies testing for the effect of the compound on growth, development, pubescence, and reproduction—the effects of long-term administration. Typically, these studies are not completed until Phase III. Studies in pediatric patients should be scheduled so that the effects of the test drug can be assessed during various stages of development, especially during periods of rapid growth and development.

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