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，通过提供涉及癌症患者的临床试验的科学审查、优先排序和监测来支持临床研究。WCI CTO的长期目标是通过支持癌症研究所成员的高质量、高影响力的临床研究来推进癌症治疗的进展。WCI CTO的重点是帮助开发和支持机构临床研究，特别是1期和研究者发起的研究。CTO支持临床研究基础设施，使WCI研究人员能够启动早期临床试验，积累临床研究的合格受试者，并完成必要的病例报告表格和监管文件。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的实验室研究，包括药代动力学采样和生物标志物。实现前期支持的目标

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.