Protocol Specific Research Support

CCSG的方案特定研究支持（PSRS）资助研究人员 致力于开发，实施，进行，并完成高优先级，创新 药物启动的I期临床试验。该资源是癌症中心的高度优先事项， 对转化研究和早期临床研究的更新和坚定承诺。这尤其 资助机制对于YCC履行其使命，将最令人兴奋的发现转化为 将来自YCC研究实验室的科学应用于临床。因此，这些类型的转化临床 研究在性质和设计上是复杂的，因为它们包含了重要的相关性，生物学， 药代动力学和药效学研究。虽然YCC PSRS始终支持自动启动 研究，PSRS预计在2010年期间，由制药商发起的临床试验将显著增加。 下一个供资期间，支持这些调查员的需要增加。PSRS的主要目标是 （1）为制药商启动的试点I期临床研究提供护理和数据管理支持，（2） 在创新研究的开发和启动方面为研究者提供协助，（3）提供 协助确定这些临床研究的合格性和招募患者，（4）确保安全 通过监测患者进行临床研究，（5）及时提供源文件， 完整录入PRS，（6）报告研究结果，以及（7）确保符合联邦和监管要求 任务。这项工作需要有经验的研究护士和数据管理人员来确保 这些重要研究的安全性、完整性和成功。工作人员的连续性是成功的关键 这些研究包括目前正在进行的研究，以及将在下一个资助期内开展的研究。的PSR 与YCC临床试验计划的其他关键要素密切互动，其中包括临床 研究服务（CRS）和方案审查和监测系统（PRMS），并在 这三个要素是YCC临床的基石， PSRS还与YCC临床/转化研究密切互动， 程序，包括发育治疗学（DT），放射生物学和放射治疗（R&R）， 免疫学和免疫疗法（I & I）。皮肤癌的孢子，特别关注黑色素瘤 展示了DT，l&l和Cancer之间高度跨学科的跨项目合作 预防和控制计划，并强调重点发展创新的临床研究， 直接来自YCC临床前实验室研究。

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.