The Protocol Specific Research Support (PSRS) funding of the CCSG supports research personnel dedicated to the development, implementation, conduct, and completion of high priority, innovative investigator-initiated phase I clinical trials. This resource is of high priority to the Cancer Center given the renewed and strong commitment to translational research and early phase clinical studies. In particular, this funding mechanism is critical for the YCC to fulfill its mission of translating the most exciting discoveries and science coming from YCC research labs into the clinical setting. As such, these types of translational clinical studies are complex in nature and design, as they incorporate important correlative, biologic, pharmacokinetic, and pharmacodynamic studies. While the YCC PSRS has always supported investigatorinitiated studies, the PSRS anticipates a significant increase in investigator-initiated clinical trials during the next funding period with an increased need to support these investigators. The main goals of the PSRS are to (1) provide nursing and data management support for investigator-initiated pilot phase I clinical studies, (2) provide assistance to investigators in the development and start-up of innovative studies, (3) provide assistance in eligibility determination and recruitment of patients for these clinical studies, (4) ensure the safe conduct of clinical research by monitoring patients, (5) provide source documentation for timely and complete entry in the PRS, (6) report study results, and (7) ensure compliance with federal and regulatory mandates. This effort .will require research nurses and data managers who have experience to ensure the safety, integrity, and success of these important studies. The continuity of staffing is essential to the success of studies presently on-going and to those that will be developed in the next funding period. The PSR interacts closely with the other key elements of the YCC clinical trials program, which include the Clinical Research Services (CRS) and the Protocol Review and Monitoring System (PRMS), and working together in an integrated, highly coordinated manner, these 3 elements serve as the cornerstone for the YCC clinical investigations program, The PSRS also interacts closely with the YCC Clinical/Translational Research Programs, including Developmental Therapeutics (DT), Radiobiology &Radiotherapy (R&R), and Immunology &Immunotherapy (l&l). The SPORE in Skin Cancer with a special focus on melanoma showcases the highly interdisciplinary, interprogrammatic collaborations between the DT, l&l, and Cancer Prevention and Control Programs and highlights the focus on developing innovative clinical studies that stem directly from YCC pre-clinical laboratory investigation.
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