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W hen oncology community leaders got their first look at the National Cancer Institute’s proposal for renovating its clinical trial system, they found some fundamental changes. NCI’s system is based largely on the longestablished clinical trial cooperative groups, and many leaders in those groups hoped the proposals would include more funding and less regulation, as recommended in an Institute of Medicine (IOM) report last spring. But the proposed new system, which includes major changes to infrastructure, goes beyond that report, including major changes to infrastructure. The 10 cooperative groups would be consolidated into fi ve: the existing Children’s Oncology Group plus four adult multispecialty, national groups. That means the nine existing adult groups will have to merge or reconfi gure their structures by November 2012, the deadline for grant proposals in the new system. Groups will have to submit proposals in response to a request for applications, now being developed. Applications will go through a formal review process, also under development. All fi ve groups will then undergo a competitive review at the same time, every 5 years, to determine merit-based funding. “We are looking for a way to provide an infrastructure that is able to take advantage of scientifi c opportunities across the board,” said James Doroshow, M.D. , director of NCI’s treatment division. Doroshow discussed the new system at the December meeting of the Cancer Treatment Advisory Committee (CTAC). “I hope to have four harmonized operations centers and four data management centers instead of nine, four diseasespecifi c committees for each malignancy instead of eight in some cases.” The new system would also establish three human tissue banks instead of nine. Doroshow acknowledged that the proposed changes, although responding to the IOM report, went well beyond it. “There are several members of CTAC who were part of the IOM committee, which gives us a unique perspective for understanding the background of their recommendations,” said Doroshow. “We want to implement a comprehensive approach to change that acknowledges the IOM recommendations but fundamentally alters current incentives at all levels to Proposed New Clinical Trial System at NCI Gets Mixed Reviews