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National Cancer Institute Working Group Proposes Restructuring Clinical Trials Network

The National Cancer Institute (NCI) Clinical Trials Working Group presented its draft recommendations at the NCI advisory board meeting on February 17, 2005. The group called for significant changes in the current structure and procedures to allow for greater efficiencies in recruitment, data sharing, and regulation. The working group was formed in 2004 to examine all aspects of the NCI clinical trials structure.

Although not advocating a complete restructuring of the current system, the group called for greater coordination and standardization to streamline the entire process of clinical trials. The initiation of trials could be shortened by months with greater coordination between the NCI, Food and Drug Administration (FDA), and the Health and Human Services (HHS) Office of Human Research Protections. Redundancy has been alleviated by the joint NCI/FDA expedited approval process and could be further reduced by incorporation of the HHS. Standardized procedures and regulations for personnel credentialing, publication and property rights, and data collection could reduce the timeline from design and approval of the trial to its conduct and data analysis. This streamlining and acceleration could serve to attract more subjects who are currently excluded owing to health issues or eligibility requirements.

In light of the current budget constraints, the NCI will also need to prioritize clinical trials. The group's prioritization subcommittee advised restructuring the NCI organizational structure to incorporate input from clinicians, industry, and patient advocacy groups about which clinical trials should make use of available funds. These entities could also form a permanent clinical trials subcommittee proposed by the working group that would oversee all NCI clinical trials. A comprehensive database describing all NCI clinical trials would be monitored by this subcommittee and used to prioritize funding.

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