期刊
ANNUAL REVIEW OF MEDICINE
卷 59, 期 -, 页码 1-12出版社
ANNUAL REVIEWS
DOI: 10.1146/annurev.med.59.090506.155819
关键词
biomarkers; biomarker qualification; clinical trials
Societal expectations about drug safety and efficacy are rising while productivity in the pharmaceutical industry is falling. In 2004, the US Food and Drug Administration introduced the Critical Path Initiative with the intent of modernizing drug development by incorporating recent scientific advances, such as genomics and advanced imaging technologies, into the process. An important part of the initiative is the use of public-private partnerships and consortia to accomplish the needed research. This article explicates the reasoning behind the Critical Path Initiative and discusses examples of successful consortia.
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