Gynecologic Oncology Group Statistical and Data Center

本申请包括对GOG统计和数据中心(SDC)基本功能的广泛描述(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)。这些活动的范围和方法需要研究主席、临床数据 协调员和统计学家反映了GOG对数据质量的重视。此外，该提案还介绍了SDC内的统计资源。通过招聘工作人员和三名在翻译研究、生活质量和癌症预防和控制领域提供杰出能力的外部统计人员作出的大量时间资源承诺，大大增加了统计专业知识。统计人员进一步增加了翻译研究和医学伦理学方面的博士专业知识。与生物统计部、纽约州立大学布法罗分校和罗斯威尔公园癌症研究所生物统计部的密切工作关系随着这些部门的不断发展而不断发展。这些举措极大地提高了SDC的整体能力，以满足GOG迅速扩大的需求。第三，赠款概述了重要的信息技术专长的证据，以及对最佳利用现代技术的重大承诺。这些举措包括计算机设备和软件的重大升级、基于网络的病人进入、通过优化使用基于网络的系统来加强GOG成员之间的沟通，以及开发生物信息学和标本跟踪机制(BAST)。第四，所使用的方法已经形式化成了一套标准 操作程序。此外，该申请还讨论了SDC的几个独一无二的功能，这些功能对于GOG的持续成功至关重要。试验设计和执行的方法强调了真正的多模式互动的关键重要性。这一过程要求统计学家了解要调查的临床问题。在这方面，SDC在妇科恶性肿瘤临床试验中的经验值得注意。它在有效设计和执行GOG试验方面具有无可估量的价值。同样，统计学家和研究主席之间也需要进行大量的互动。在全职内部统计员的基础上增加诸如非现场统计员所提供的专门知识当然是可行的。SDC已有效地将这些组件组合在一起。SDC监督一个有效和独特的监测多机构I期试验的机制，该机制加快了确定患者进入和研究剂量水平暂停的复杂过程。在过去的28年里，SDC一直在不断发展，以满足GOG日益增长的需求。在过去五年中，GOG正在发展的领域以及SDC必须应对的挑战的数量都出现了前所未有的增长。本摘要指出了坚实基础的理由，并强调了SDC的新举措和独特方面，这些举措和独特方面满足了各种新的和不断扩大的努力领域的日益增长的需求：转化研究、生活质量研究、癌症预防和控制调查，以及开发新的研究方案的创新方法。

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 interactions between the Study Chair, Clinical Data Coordinator, and Statistician reflect the importance the GOG attaches to data quality. Seeondly, the proposal describes statistical resources within the SDC. Statistical expertise has been significantly augmented by staff recruitment and by significant time resources commitments from three outside statisticians who provide outstanding capability in the areas of translational research, quality of life, and cancer prevention and control. The statistical staff is further augmented by Ph.D. expertise in translational research and medical ethics. Close working relationships with both the Department of Biostatistics, SUNY at Buffalo and the Department of Biostatistics at Roswell Park Cancer Institute are in evolution as these departments continue to grow. 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 expertise 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, enhanced communication among GOG members through the optimal use of a Web-based system, and development of a mechanism for Bioinformatics and Specimen Tracking (BAST). Fourthly, the methods utilized have been formalized into a set of Standard Operating Procedures. Additionally, the application discusses several features of the 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. 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 has certainly been feasible to add specific expertise such as that which is provided by the off-site statisticians to the full-time in-house statisticians. The 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 SDC has always evolved to meet the growing needs of the GOG over the last 28 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.