Modern biomedical research is being transformed by what is increasingly becoming a flood of information. Electronic medical records have opened unprecedented opportunities for studies investigating a wide range of problems ranging from epidemiological aspects of human disease to the comparative effectiveness of various treatment protocols. Similarly, genomic technologies such as DNA microarrays and next-generation DNA sequencing have opened a floodgate of data and information that promises to shed light on the complex nature of human disease. In this information-rich age, one of the greatest challenges is therefore no longer generating data, but effectively integrating it so that it can be used to advantage. Because clinical practice has long been separate from the research enterprise at most academic health centers, a situation has evolved in which clinical and research data exist in separate, often incompatible domains with a variety of technical, institutional, and organizational barriers between them. Further limiting our ability to extract the maximal value of the data we have available is the fact that data within institutions is rarely integrated with the vast body of data available in the public domain. Two large sources of clinical data will be used in this program project. The data for both of these large IFM/DFCI collaborative clinical trials (1000 MM patients treated with RVD with or without high dose therapy and transplant;1210 patients with either monoclonal gammopathy of undetermined significance or smoldering MM (SMM) followed for progression to active MM) are collected in an established clinical trials database at the IFM.
The aims of Core B are to create, maintain and quality control the clinical database (Specific Aim 1);to collect, transport, process and store tissue samples from all sites utilizing standardized procedures in centralized tissue banks (Specific Aim 2);and to develop a data warehouse to integrate the sample tracking and oncogenomic information with the relevant clinical data from the clinical trials database with web based query capabilities (Specific Aim 3).
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