GYNECOLOGIC ONCOLOGY GROUP STATISTICAL AND DATA CENTER

描述（由申请人提供）：本申请包括广泛的 GOG统计和数据中心（SDC）基本功能描述 （设计、随机化、数据采集和处理、质量控制， 研究监测、分析和结果展示）。这些的范围 需要广泛互动的活动和方法 研究主席、临床数据协调员和统计学家之间的关系反映了 GOG对数据质量的重视。第二，建议 描述了GOG SDC内统计资源的重大扩展。 通过征聘工作人员，统计专门知识得到了显著增强 以及三名外部统计人员投入大量时间， 在翻译研究领域提供卓越的能力（博士。 Richard Krycio）、生活质量（霍华德泰勒博士）和癌症预防 罗杰·普里奥雷博士（Roger Priore）统计人员进一步增加， 博士药代动力学、医学伦理学和心理学方面的专业知识。密切 与社会和预防医学系的工作关系， 纽约州立大学布法罗分校正在发展，因为该部门开始招聘 四名博士统计学家组成生物统计学部门。这些 这些举措极大地增强了战略防御中心的整体能力， 以满足政府快速增长的需求。第三，补助金概述 有证据表明进行了大量信息技术征聘， 致力于最佳利用现代技术。这些举措包括 计算机设备和软件的重大升级， 进入，并通过优化使用GOG成员之间的沟通 基于Web的系统。 此外，该应用程序还讨论了GOG SDC的几个功能， 对GOG的持续成功至关重要。的途径 试验设计和执行强调真正的多模态的至关重要性 互动这个过程需要统计人员理解 需要研究的临床问题。在这方面， 妇科恶性肿瘤临床试验中的SDC值得注意， 无法复制。它在有效的设计和执行中具有无价的价值 GOG审判同样，统计员和 需要学习椅。增加具体的 专门知识，例如由场外统计人员向 全职内部统计员。GOG SDC有效地结合了这些 件.可持续发展委员会监督一个有效和独特的监察机制， 多机构I期试验，这加快了复杂的过程， 确定患者入组和研究剂量水平暂停。GOG SDC已 在过去的25年里，它一直在不断发展，以满足GOG不断增长的需求。 在过去的五年里， GOG正在发展，SDC必须应对的挑战数量 回答。本摘要指出了坚实基础的理由， 重点介绍可持续发展委员会的新措施和独特之处， 在各种新的和不断扩大的奋进领域不断增长的需求： 转化研究，生活质量研究，癌症研究 发展新的生物多样性的创新办法 研究方案。

DESCRIPTION (provided by applicant): This application includes extensive descriptions of basic functions of the GOG Statistical and Data Center (SDC) (design, randomization, data acquisition and processing, quality control, study monitoring, analysis, and presentation of results). The scope of these activities and the method of approach which requires extensive interaction between study chairman, clinical data coordinator, and statistician reflect the importance the GOG attaches to data quality. Secondly, the proposal describes a major expansion of statistical resources within the GOG SDC. Statistical expertise has been significantly augmented by staff recruitment and by significant time commitments from three outside statisticians who provide outstanding capability in the areas of translational research (Dr. Richard Kryscio), quality of life (Dr. Howard Thaler), and cancer prevention and control (Dr. Roger Priore). The statistical staff is further augmented by Ph.D. expertise in pharmacokinetics, medical ethics, and psychology. Close working relationships with the Department of Social and Preventive Medicine, SUNY at Buffalo are in evolution as that department begins recruitment for four doctoral statisticians to comprise a Division of Biostatistics. These initiatives have dramatically enhanced the overall capabilities of the SDC to meet the rapidly expanding needs of the GOG. Thirdly, the grant outlines evidence of significant information technology recruitment and a major commitment to the optimal use of modern technology. These initiatives include major upgrades of the computing equipment and software, web-based patient entry, and enhanced communication among GOG members through the optimal use of a web-based system. Additionally, the application discusses several features of the GOG SDC which are unique and crucial to the ongoing success of the GOG. The approach to trial design and execution emphasizes the critical importance of true multimodality interaction. This process requires the statistician to understand the clinical problems to be investigated. In this regard, the experience of the SDC in clinical trials in gynecologic malignancies is noteworthy and cannot be replicated. It is invaluable in the effective design and execution of GOG trials. Likewise, significant interaction between the statistician and the study chair is required. It is certainly feasible to add specific expertise such as that which is provided by the off-site statisticians to the full-time in-house statisticians. The GOG SDC has effectively combined these components. The SDC oversees an effective and unique mechanism for monitoring multi-institutional Phase I trials, which expedites the complex process of determining patient entry and study dose-level suspension. The GOG SDC has always evolved to meet the growing needs of the GOG over the last 25 years. The last five years have seen an unprecedented growth of the areas in which the GOG is evolving and the number of challenges to which the SDC has had to respond. This summary notes the rationale for a solid foundation and highlights new initiatives and unique aspects of the SDC which meet the growing needs in a variety of new and expanding areas of endeavor: translational research, quality of life studies, investigations in cancer prevention and control, and innovative approaches to the development of new regimens for study.