Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
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AIDS Treat News. 1999 Jan 8;(No 310):6. Unique Identifier : AIDSLINE AIDS/20700012
James JS
Abstract: The problems that occurred during the development process of abacavir and the limitations of the data that resulted from that process can indicate ways to improve future research. For instance, researchers need to explore how to design a study with more far-reaching results. Also, more studies are needed about the mechanisms of how new drugs work instead of just whether or not they work. Several years ago, the FDA evaluated their drug approval process in order to design a more efficient system. Since that process concentrates more on the end stages of drug development, another evaluation is needed to improve the design of large clinical trials that occur during the early stages of drug development.
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