PROTOCOL SPECIFIC RESEARCH

项目摘要 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的开展作为最高优先事项。CCSG方案特定研究支持将为Winship临床试验办公室（CTO）和I期临床试验部门（CTU）提供可用资源，以支持机构临床研究，用于制药商启动的I期和II期研究。Winship研究人员利用CTO的临床研究基础设施支持成功完成并报告了I期研究，包括在专门的I期CTU中获取关键临床样本。在此支持下，可以提供专门的临床研究工作人员，他们采集和处理用于药代动力学、药效学和生物标志物采样的临床样本。为了实现支持Winship研究者开展的早期、由研究者发起的临床研究的目标，将追求以下两个具体目标： 1.确定、启动和完成由Winship研究者撰写或共同撰写的0期、I期和II期机构临床研究的招募。 2.获取，处理和分析相关的实验室样品，以推进Winship研究计划的科学目标。 成功地完成科学上严格的机构临床试验与新的抗癌剂将导致财团和合作组试验，将验证有前途的新疗法的疗效。

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.