Gynecologic Oncology Group Statistical and Data Center

妇科肿瘤组统计和数据中心

• 批准号: 6904473
• 负责人: JOHN A BLESSING
• 金额: $ 524.29万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 1984
• 资助国家: 美国
• 起止时间: 1984-07-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6904473
• 关键词: cancer information system; cancer prevention; cancer registry /resource; clinical research; clinical trials; computer data analysis; cooperative study; data management; data quality /integrity; experimental designs; female reproductive system neoplasm; human data; information dissemination; patient oriented research; quality of life; statistical service /center; statistics /biometry

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.

该应用程序包括 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、分析和结果呈现）。这些活动的范围和方法需要临床数据研究主席之间的广泛互动 协调员和统计员体现了GOG对数据质量的重视。首先，该提案描述了 SDC 内的统计资源。通过工作人员的招聘和三名外部统计学家投入的大量时间资源，统计专业知识得到了显着增强，他们在转化研究、生活质量和癌症预防和控制领域具有出色的能力。统计人员进一步增加了博士。转化研究和医学伦理方面的专业知识。随着纽约州立大学布法罗分校生物统计系和罗斯威尔公园癌症研究所生物统计系的不断发展，我们与这些部门的密切工作关系也在不断发展。这些举措极大地增强了 SDC 的整体能力，以满足 GOG 快速增长的需求。第三，该赠款概述了重要信息技术专业知识的证据以及对现代技术最佳利用的重大承诺。这些举措包括对计算设备和软件进行重大升级、基于网络的患者录入、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样本跟踪 (BAST) 机制。第四，所使用的方法已正式形成一套标准 操作程序。此外，该申请还讨论了 SDC 的几个独特功能，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态交互的至关重要性。这个过程需要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方面的经验值得关注。它对于 GOG 试验的有效设计和执行具有无价的价值。同样，统计学家和研究主席之间需要进行大量互动。向全职内部统计员添加特定的专业知识（例如由场外统计员提供的专业知识）当然是可行的。 SDC 有效地将这些组成部分结合起来。 SDC 负责监督一个有效且独特的机制，用于监测多机构 I 期试验，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 28 年里，SDC 一直在不断发展，以满足 GOG 不断增长的需求。过去五年，GOG 发展的领域以及 SDC 必须应对的挑战数量都出现了前所未有的增长。本摘要指出了坚实基础的基本原理，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不断增长的需求：转化研究、生活质量研究、癌症预防和控制的调查以及开发新研究方案的创新方法。