PROTOCOL SPECIFIC RESEARCH

项目总结 Winship癌症研究所(Winship)将其成员研究人员开发的高影响力临床研究作为极高优先事项给予最高优先考虑。CCSG方案特定研究支持将提供Winship临床试验办公室(CTO)和第一阶段临床试验单位(CTU)的可用资源，以支持机构临床研究，用于研究人员发起的第一阶段和第二阶段研究。Winship研究人员利用CTO提供的临床研究基础设施支持，成功完成并报告了I期研究，其中包括在专门的I期CTU中获取关键临床样本。专门的临床研究人员可以在这种支持下获取和处理用于药代动力学、药效学和生物标记物采样的临床样本。为了实现支持Winship调查员发起的早期临床研究的目标，将实现以下两个具体目标： 1.确定、启动和完成由Winship调查人员撰写或共同撰写的0期、I期和II期机构临床研究的应计项目。 2.获取、处理和分析相关实验室样品，以推进Winship研究计划的科学目标。 新型抗癌药物在科学上严格的机构临床试验的成功完成将导致联合体和合作小组试验，这些试验将验证有希望的新疗法的疗效。

PROJECT SUMMARY The Winship Cancer Institute (Winship) accords highest priority to the conduct of high-impact clinical research developed by its member investigators as an extremely high priority. CCSG Protocol-Specific Research support will provide available resources of the Winship Clinical Trials Office (CTO) and the Phase I Clinical Trials Unit (CTU) to support institutional clinical research studies, for investigator-initiated phase I and II studies. Winship investigators have successfully completed and reported on phase I studies utilizing clinical research infrastructure support from the CTO that includes the acquisition of critical clinical samples in the specialized Phase I CTU. Dedicated clinical research staff members who acquire and process clinical samples for pharmacokinetic, pharmacodynamic, and biomarker sampling can be made available with this support. To achieve the goals of supporting early phase, investigator-initiated clinical research by Winship investigators, the following specific two objectives will be pursued: 1. To identify, initiate, and complete accrual to phase 0, phase I, and phase II institutional clinical research studies which have been authored or co-authored by Winship investigators. 2. To acquire, process, and analyze correlative laboratory samples which advance the scientific goals of the Winship research programs. Success in the completion of scientifically rigorous institutional clinical trials with novel anti-cancer agents will lead to consortium and cooperative group trials that will validate the efficacy of promising new therapies.