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首页> 美国政府科技报告 >Restructuring the National Cancer Clinical Trials Enterprise. Report of the Clinical Trials Working Group of the National Cancer Advisory Board.
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Restructuring the National Cancer Clinical Trials Enterprise. Report of the Clinical Trials Working Group of the National Cancer Advisory Board.

机译：重组国家癌症临床试验企业。国家癌症咨询委员会临床试验工作组的报告。

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In January 2004, Dr. Andrew von Eschenbach, Director of the National Cancer Institute (NCI), established the Clinical Trials Working Group (CTWG) to advise the National Cancer Advisory Board (NCAB) on whether and in what ways the NCI-supported national clinical trials enterprise should be restructured to realize the promise of molecular medicine for advancing oncologic clinical practice in the 21st century. The CTWG is a broadly constituted panel with experts from academic research institutions, community oncology practices, the pharmaceutical and biotechnology industries, cancer patient advocacy groups, NCI, the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS). The CTWG first reached consensus on four critical goals for designing a restructured national clinical trials enterprise that is not only more efficient and coordinated but founded on the best science. The first goal was to improve coordination and cooperation among the functionally diverse components of the current system, including industry and federal regulatory agencies. The second goal was to improve prioritization and scientific quality by developing an open and transparent process for the design and prioritization of clinical trials that are science-driven and meet the needs of patient care. The third goal was to improve standardization of tools and procedures for trial design, data capture, data sharing, and administrative functions to minimize duplication of effort, and to facilitate development of a shared infrastructure to support an integrated national cancer clinical trials network. The fourth goal was to improve operational efficiency by increasing the rate of patient accrual and reducing operational barriers so that trials can be initiated and executed in a timely, cost-effective manner.

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