CLINICAL TRIALS- SHARED RESOURCES

Winship癌症研究所的临床试验共享资源，简称临床试验办公室（WCI CTO），是WCI临床试验研究整体支持的一部分，其活动与方案审查和监测系统（PRMS）和数据安全监测计划（DSMP）协调。WCI CTO的总体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动癌症治疗的进展。在我们的组织模式中，以疾病为重点的医生研究人员直接与研究护士，协调员和监管专家合作，组织成九个疾病或基于站点的管理团队，称为工作组。工作组的工作人员协助临床研究者按照治疗性临床研究方案招募受试者，并负责高质量的数据收集和提交。工作组涵盖所有临床 埃默里大学及其临床附属机构开展的研究者和临床试验活动。这些 活动由一个中央行政核心支持和协调，该核心负责监督临床试验的优先顺序;预算和财务;工作人员培训;制定和实施临床试验启动、应计、管理和运营的政策和程序;质量保证和审计职能;以及监管事务。WCI CTO还与生物统计学共享核心资源协调，为设计制药商发起的机构试验提供支持。WCI CTO与医学院的临床试验办公室密切合作，涉及监管合规和预算，并与大学的赞助项目办公室合作解决合同问题。WCI CTO支持代表所有四个WCI科学项目领域的研究者进行治疗性、预防性、辅助性、相关性和非干预性研究。在医学总监Edmund Waller（医学博士、哲学博士）和副总监Stephanie McMillan（注册护士）、Carol Hill（注册护士）（临床事务）和Leah霍洛威（法规事务）的指导下，WCI CTO维护一个用于成人和儿科试验的集中数据库，并监督CTO及其工作人员的所有服务和职能。2007年，442名独特的癌症患者参加了治疗性临床试验，占当年新发现的可报告癌症患者数量的12%。参加治疗性临床试验的患者数量在过去6年中增加了两倍，其中过去3年的最快增长率见于治疗性机构研究。扩大获得临床研究和癌症患者的治疗机构研究的持续积累是实现温希普癌症研究所的使命的核心。

The Winship Cancer Institute's Clinical Trials Shared Resource, referred to as the Clinical Trials Office (WCI CTO), is part of the overall support for clinical trials research in the WCI and its activities are coordinated with the Protocol Review and Monitoring System (PRMS) and Data Safety Monitoring Plan (DSMP). The overall goal of the WCI CTO is to advance progress in cancer care through the support of highquality, high-impact clinical research by Cancer Institute members. In our organizational mode diseasefocused physician investigators work directly with research nurses, coordinators and regulatory specialists organized into nine disease or site-based management teams called Working Groups. The staff in the Working Group assist clinical investigators in enrolling subjects on therapeutic clinical research protocols and are responsible for high-quality data collection and submission. The Working Groups encompass all clinical investigators and clinical trial activities conducted at Emory University and its clinical affiliates. These activities are supported and coordinated by a central administrative core that provides oversight of clinical trial prioritization; budget and finances; staff training; development and implementation of policies and procedures for clinical trials activation, accrual, management, and operations; quality assurance and auditing functions; and regulatory affairs. The WCI CTO also provides support for designing investigator-initiated institutional trials in coordination with the Biostatistics Shared Core Resource. The WCI CTO works closely with the School of Medicine's clinical trials office as related to regulatory compliance and budgets and with the University's Office of Sponsored Programs for contracting issues. The WCI CTO supports therapeutic, prevention, ancillary, correlative, and non-interventional studies for investigators representing all four WCI scientific program areas. Under the direction of the Medical Director, Edmund Waller, MD, PhD, and the Associate Directors, Stephanie McMillan, RN, and Carol Hill, RN (Clinical Affairs), and Leah Holloway (Regulatory Affairs), the WCI CTO maintains a centralized database for both adult and pediatric trials and oversees all the services and functions of the CTO and its staff. In 2007, 442 unique cancer patients were accrued to therapeutic clinical trials representing 12% of the number of reportable cancer patients newly seen in that year. The number of patients enrolled on therapeutic clinical trails and has tripled over the past 6 years, with the fastest growth rates in the past 3 years seen in therapeutic institutional studies. Expanded access to clinical research and continued accrual of cancer patients onto therapeutic institutional studies are central to achieving the mission of the Winship Cancer Institute.