Overview and Response to Previous Review The Robert H. Lurie Comprehensive Cancer Center of Northwestern University (Lurie Cancer Center) is dedicated to the conduct of innovative, translational clinical research. Novel investigator-initiated clinical trials (IITs) are a key element ofthe Lurie Cancer Center clinical research program and are of highest priority. In this competitive granting environment, funding for such studies is often either unavailable or only partially available. While industry sponsors are an important source of funds for such trials, the start-up process with our industry partners can be lengthy. The work of the Operational Efficiency Working Group (OEWG) has made it clear that rapid activation and enrollment to trials is vital. As such, the Lurie Cancer Center is committed to facilitating local, IITs through the CCSG mechanism of Protocol Specific Research Support (PSRS). PSRS funding is competitive in nature and supports protocol coordination and data management for early phase research trials. The goal of such support is to allow for the rapid development and completion of novel, translational hypothesis-driven trials that show promise for advancement to later phase clinical research deserving of independent funding. IITs are those institutional trials that are conceived of and written by Lurie Cancer Center investigators, and fall under the purview ofthe Lurie Cancer Center for ensuring appropriate conduct ofthe trial. Since the last competing application, the Lurie Cancer Center has provided support to 21 trials developed by Lurie Cancer Center members. The funding request for PSRS in this competing application consists of one Study Coordinator and one Data Manager.
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