CLINICAL TRIALS- PROTOCOL SPECIFIC

Winship癌症研究所临床试验办公室(WCI CTO)是癌症研究所的共享资源，通过对涉及癌症患者的临床试验提供科学审查、优先排序和监测来支持临床研究。WCI首席技术官的长期目标是通过支持癌症研究所成员的高质量、高影响的临床研究来推动癌症治疗的进步。WCI首席技术官的重点是帮助开发和支持机构临床研究，特别是第一阶段和研究人员发起的研究。首席技术官支持临床研究基础设施，使世界卫生组织的研究人员能够启动早期临床试验，使符合条件的受试者参加临床研究，并完成必要的病例报告表和法规文件。专门的临床研究人员获取和处理适当的临床样本，促进临床研究与相关实验室研究，包括药代动力学采样和生物标记物。实现支持早期阶段的目标 WCI调查人员的临床研究，以推进该计划的科学任务，将追求以下两个具体目标： 1.启动并吸引受试者参加0期、1期和2期机构临床研究 由WCI调查人员撰写或合著的研究。 2.获取、处理和分析相关实验室样品，以促进科学目标的实现 WCI科学项目的。 新型抗癌药物在科学上严格的机构第一阶段和第二阶段临床试验的成功完成，将导致联盟和合作小组第三阶段试验，这些试验将验证有希望的新疗法的疗效。

The Winship Cancer Institute Clinical Trials Office (WCI CTO) is a Shared Resource of the Cancer Institute that supports clinical research by providing scientific review, prioritization and monitoring of clinical trials involving cancer patients. The long-term goal of the WCI CTO is to advance progress in cancer care through the support of high-quality, high-impact clinical research by Cancer Institute members. The focus of the WCI CTO is to help develop and support institutional clinical research studies, particularly phase 1 and investigator-initiated studies. The CTO supports the clinical research infrastructure that allows WCI investigators to initiate early phase clinical trials, to accrue eligible subjects to clinical research studies, and to complete necessary case report forms and regulatory documents. Dedicated clinical research staff that acquire and process the appropriate clinical samples facilitates clinical studies with correlative laboratory studies, including pharmacokinetic sampling and biomarkers. To achieve the goals of supporting early phase clinical research by WCI investigators that advances the scientific missions of the Programs, the following specific two objectives will be pursued: 1. To initiate and accrue subjects to phase 0, phase 1, and phase 2 institutional clinical research studies that have been authored or co-authored by WCI investigators. 2. To acquire, process, and analyze correlative laboratory samples that advance the scientific goals of the WCI Scientific Programs. Success in the completion of scientifically rigorous institutional phase 1 and 2 clinical trials with novel anticancer agents will lead to consortium and cooperative group phase 3 trials that will validate the efficacy of promising new therapies.