Roswell Park Cancer Institute (RPCI) has considerable expertise in the development and conduct of pilot/pre-phase I, phase I and phase l/ll studies, which are the foundation for the development of novel therapeutic approaches in hematologic and solid tumor malignancies. Early Phase Clinical Research Support (EPCRS) provides resources for the short-term conduct of early phase agent or device studies developed by RPCI investigators and emanating from the CCSG research programs. The continued vitality and translational potential of CCSG Programs relies critically on this support for early phase studies, which rarely receive support through other mechanisms. With the recent recruitment of a number of new investigators to the CCSG Programs and RPCI, accrual to these studies has increased substantially, for example, from 24 (2008) to 118 (2012) for phase I investigator-initiated studies. Alex A. Adjei, MD, PhD, Associate Director for Clinical Research, oversees this CCSG component. The primary responsibilities of the clinical research coordinators in this Resource are the implementation, conduct, oversight, collection and quality control of data for phase I and pilot studies. Dr. Adjei oversees the prioritization for the use of EPCRS resources in his capacity as Associate Director for Clinical Research. The process builds on established mechanisms and structures through the Protocol Review and Monitoring System to ensure that only high priority, eligible studies receive support. In order to be eligible for support through EPCRS, the study must be led by an RPCI investigator and/or have resulted from clinical or preclinical studies performed by an RPCI investigator with an RPCI faculty member as a co-investigator. In addition, the study should not be supported by peer-reviewed funding, a co-operative agreement or other contracts. Over the last grant period, a number of studies have been initiated that were based on research findings from investigators involved in the CCSG programs. These trials either had laboratory funding but not clinical trial funding or they led to peer-reviewed funding after support by the EPPRS. Examples include phase I studies of TRC105 [Dr. Ben Seon (TM)] DAMD17031046), cixutumumab + eriofinib [Adjei (ET), R21 CAI 35595], Eriofinib chemoprevention [Dr. Mary Reid (PS), N01 CN-35157], and a vaccine study for NY-ESO expressing ovarian and fallopian tube cancers [Dr. Kunle Odunsi/Dr. ProtuI Shrikant (TH), R01CA158318].
Eariy phase clinical research is essential to translating outstanding basic science into clinical care. EPCRS provides critical support to advance the most novel science into clinical testing prior to extramural funding.
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