The NCCTG Statistical/Data Management Office provides statistical collaboration and data management support for NCCTG clinical trials, translational, and related research activities. The office has a long history of statistical and technological innovation with the goal of improving the conduct of clinical trial design, monitoring, and analysis. Recently, statistical research has focused on refining and simplifying methods for assessing patient quality of life, developing survival analysis methods for multiple event data and meta analyses, and investigating novel designs for phase II clinical trials. In addition, statistical personnel have assumed the principal investigator role on selected recent clinical studies. Throughout the unit's history, a focus has been on developing and implementing systems that incorporate quality control into all aspects of study development and conduct. Recently, these efforts have focused on harnessing the power of the Internet to improve the data quality and efficiency of clinical trials. The data management office has developed and is in the process of implementing several web-based systems, including remote registration/randomization and remote data entry. When fully implemented during the proposed grant period, these systems will allow greater efficiency both at the NCCTG Research Base and at NCCTG member institutions. NCCTG forms have been radically redesigned to allow increased flexibility and efficiency. Data elements have been reduced substantially to eliminate unnecessary items. Additionally, we have developed automated quality control editing programs with both within-form and between-form consistency and integrity checks, thus reducing the manual effort required to assure the highest quality data. We have developed a database that allows substantial flexibility to manage non-traditional datatypes. As the NCCTG moves forward into new and expanding areas of emphasis, such as translational research, novel therapeutics, genetic epidemiology, and quality of life issues, the Statistical/Data Management Office has demonstrated the ability to continue to evolve to provide the highest level of collaboration for NCCTG clinical investigators.
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