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.
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