PROTOCOL SPECIFIC RESEARCH SUPPORT The University of Michigan Comprehensive Cancer Center (UMCCC) places the highest priority on the design and conduct of innovative investigator-initiated clinical trials. The Clinical Trials Office (CTO) supports this effort by providing data management and regulatory support of clinical trials. These services are provided based on guidance from the scientific review and prioritization through the Protocol Review Committees, in consultation with the Associate Director for Clinical Research. As described in the Protocol Review and Monitoring section, studies are reviewed for scientific merit by the Protocol Review Committee and on approval, a priority score is assigned. These priority scores are used by the Cancer Center senior leadership to guide resource allocation decisions including the assignment of data management services provided by the CTO with support from the Cancer Center Support Grant, and other institutional resources as appropriate. The CTO supports all clinical research performed within the Cancer Center. As previously stated, over this grant period, 52% of all therapeutic accruals at UMCCC were to investigator-initiated trials. Over the last grant period, many innovative investigator-initiated clinical research conducted at the UMCCC. During the next five years, we anticipate a significant expansion in Phase I clinical trials, particularly with the recruitment of Dr. Moshe Talpaz, who will build a Phase I program, Additional innovative investigator initiated trials are also planned as a result of Dr. Wang's research in novel compounds and the broad UMCCC efforts in cancer stem cells.
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