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.
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