The St. Jude Comprehensive Cancer Center (SJCCC) leadership views the design and implementation of investigator-initiated clinical trials as a top priority. This activity is especially valued when it translates discoveries made in SJCCC basic research laboratories to novel therapies that promise to improve the survival of children with cancer. The EPCRS provides an important mechanism of support this work enabling investigators to conduct high-priority translational studies that are not typically supported by other funding mechanisms. The EPCRS supports clinical research nurses (CRA-RNs) and clinical research associates (CRAs) dedicated to the conduct and completion of these innovative pilot and Phase I investigator-initiated trials within the SJCCC. Clinical research personnel supported by the EPCRS help manage and ensure the success of these protocols by providing a broad range of services including: maintaining protocol-specific research data;ensuring protocol compliance;preparing progress and safety reports;coordinating of specimen collection and compliance with the numerous biological and pharmacological endpoints;and coordinating the abstraction and assimilation of necessary data for analyses and reporting. Many of our EPCRS supported protocols involve an IND or IDE and/or novel agents developed within the SJCCC;thus, additional regulatory functions are required. Candidate trials for EPCRS are first identified within the SJCCC Programs and reviewed and approved by the SJCCC Director and the Associate Director for Clinical Research, who also provide budget oversight. Funding is requested for an appropriate portion of salary support for clinical research nurses, clinical research associates (CRAs), and study coordinators for work supporting EPCRS-eligible trials.
Early Phase Clinical Research Support provides funding for research nurses and data managers directly involved in the conduct of EPCRS-eligible trials. This funding enhances the SJCCC mission to develop innovative new pediatric cancer treatment strategies.
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