eaa777cd_CER_Inventory___CER_Inventory__Category
[Agency] FDA [Project Title] Building FDA CER Clinical Data and Standards Infrastructure, Tools, Skills, and Capacity: Partnership in Applied CE Science (PACES) and Host Workshops on FDA CER [Institution] JOHNS HOPKINS UNIVERSITY [Amount] $4,662,128 [Summary] This upcoming requirement is for the Partnership in Applied Comparative Effectiveness Science (PACES) which is an initiative that seeks to advance the science for such CER studies through leveraging available data, in particular the joint ARRA FDA-CER efforts, to form an enhanced standardized database, Janus. The Contractor will provide biological and clinically relevant computational expertise. The Contractor will work with FDA scientific and statistical experts to define questions, datasets and approaches for performing complex analyses for comparative and multi-study analyses on FDA and other large clinical datasets. As part of this effort the Contractor will conduct analyses on defined datasets including datasets previously developed as part the joint Janus initiative, where FDA Center specific questions will drive the data transformed, standardized and loaded into the Janus data warehouse. Additionally, the Contractor will be expected to participate in FDA-hosted scientific workshops that address issues such as methods for cross-study and other comparative analyses, best practices in CER, and candidate studies and their design and analysis methods. These strategies will also encompass clinical trial designs that can help advance personalized medicine and health outcomes both within and outside of the FDA. [Completion/ Closing Date] 09/22/2010 [Link] link [Category] 
Data Infrastructure
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