A -- SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS): Genomics and Informatics Center (GIC)

The NHLBI is seeking a Genomics and Informatics Center (GIC) for a new seven-year, multi-center clinical research study entitled, SubPopulations and InteRmediate Outcome Measures in COPD Study (SPIROMICS). SPIROMICS contractors will design and conduct an observational study with extensive subject phenotyping and molecular fingerprinting to identify subpopulations of patients with chronic obstructive pulmonary disease (COPD) and to identify and validate surrogate markers of disease severity which will be useful as intermediate outcome measures for clinical trials. A Genomics and Informatics Center (RFP-NHLBI-HR-08-06) will have primary responsibility for developing a scientific plan for achieving study aims; analyzing phenotypic and high-throughput molecular data; operating a repository of biospecimens; developing bioinformatic resources; data management; providing overall management and oversight of the study; and disseminating study results. The Radiology Center (RFP-NHLBI-HR-08-07) will have primary responsibility for standardizing imaging methods at the Clinical Centers; establishing a repository of CT image data; assessing and assuring quality of CT images; and analyzing CT images to obtain quantitative measures that may indicate the presence and/or severity of COPD or other lung diseases. Research subjects will be enrolled, phenotyped, and followed at approximately six Clinical Centers (RFP-NHLBI-HR-08-08). The GIC will have primary responsibility for operating a repository of biospecimens; developing bioinformatic resources; designing and implementing a strategy for data collection and analysis to identify subpopulations and intermediate outcome measures; training CC staff; managing study data; providing overall management and oversight of the study; and disseminating study results. Specifically, the GIC will: 1) provide expertise in genetic, genomic, and proteomic analyses; 2) provide expertise in bioinformatics, including development of controlled vocabularies and metadata elements; 3) provide biostatistical support for study design and protocol development, including sample size calculations or simulations; 4) analyze the study data; 5) provide administrative support and oversight for the study as a whole; 6) process and store biospecimens collected at the CCs; 7) coordinate, plan, make arrangements for, and participate in meetings of the study committees and boards; 8) develop and maintain web sites for study investigators; 9) establish and maintain a computer system and software needed for the storage and analysis of study data; 10) prepare and distribute periodic technical and statistical reports of study activities and progress; and 11) coordinate and track the reporting of adverse events. GIC staff must possess strong scientific qualifications related to bioinformatics, biostatistics, genetics, genomics, and proteomics. The GIC must have pulmonary medical expertise; experience in the supervision of complex, multi center clinical studies; and experience in the statistical analysis of high volume genetic, genomic, proteomic, and phenotypic data. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about October 20, 2007. This advertisement does not commit the Government to award a contract.