The Center for Clinical Epidemiology and Biostatistics (CCEB), together with the Abramson Cancer Center and Office of Human Research (OHR), at the University of Pennsylvania School of Medicine (UPENN SOM) is requesting a specialized research computing infrastructure in support of numerous, meritorious NIH-funded projects. This proposal requests a SUN SunFire 12K High-End Data Center Server, in support of large-scale database and statistical computing. The equipment will replace a seriously inadequate Oracle (r)database and statistical computing infrastructure, providing new computing performance, capacity and reliability. This proposal requests Oracle Clinical (r), specialized software that will permit a new capability for centralized management of clinical protocols, scientific data, regulatory compliance, and quality assurance. We propose these specific aims to ensure continued support of NIH projects: 1) replace an obsolete database environment, 2) replace an inadequate statistical computing environment, and 3) provide expanded computing performance, capacity, and new capability, so that current/future NIH projects can be centrally supported. In support, CCEB, the Abramson Cancer Center, and OHR present selected NIH projects potentially sustained by this equipment. CCEB projects (30 N1H projects with total costs, all years of $190M) range from statistical methodology R01s, to clinical research R01 and P01 projects, to cooperative agreements (U01,U10,U18) for Data Coordinating Centers (DCCs), and Centers for Education and Research Therapeutics (CERTs). The Abramson Cancer Center, an NCI- designated comprehensive Cancer Center, has 449 NIH funded projects ($130M total costs, all years.) This includes 19 P01s, 3 P50s, 15 cooperative U-type awards, and a vast array of clinical trials. OHR is responsible for the regulatory compliance of all clinical research (346 NIH projects with total costs, all years of $327M) conducted within the SOM. The Clinical Research Computing Unit (CRCU), a SOM Core Research Facility, provides the computing infrastructure required by large-scale clinical research and statistical methodology grants. These NIH projects require advanced database technologies, such as WWW-deployed remote data entry and management. These projects involve extensive statistical analysis, further increasing computing infrastructure needs. The CRCU provides and maintains equipment configured for the Oracle (r) Database Management System, SAS (r), S-PLUS (r), and STATA(r); however, expanding NIH research has exceeded the performance, capacity, dependability, and capability limits of the servers installed in 1997. Each newly funded NIH project further stresses the computing infrastructure, without adding new capabilities for centrally managing trials. This specialized computing equipment request meets the NCRR goals of providing shared resources across multiple grants that are cost-prohibitive and difficult to justify for individual projects.
