Humans interact with countless microorganisms on skin. In the gut, and in multiple other environments, and the NIH Roadmap Human Microbiome Project (HMP) will characterize microbial communities in a large number of healthy individuals. However, in response to RFA-HL-09-006, "The Microbiome of the Lung and Respiratory Tract in HIV-infected individuals and HIV-uninfected Controls", the characterization of the microbiome of the lung and respiratory tract in this project will provide the initial data to develop further hypotheses addressing differences between HIV-infected and HIV-uninfected individuals. The project will involve multiple studies, either single site or multiple site studies. For each of those studies, the research design will be either case-control or case-cohort design, determined based on the objective of the study. In collaboration with multiple clinical/sequencing sites, the Data Coordinating Center (DCC) for the project will address these specific aims: 1) collaborate in the development of multiple studies, including the development of the biostatlstical aspects of study design, the development of common protocols, and other study materials;2) coordinate harmonization of vocabularies and methodologies across the multiple clinical/sequencing sites and with external Investigators;3) collaborate In the implementation of studies, including coordination of training and certification of clinical/sequencing center staff;development and testing of web data entry software;and network data quality assurance;4) track and inventory collected biospecimens and support specimen banking;5) implement a web-based system to coordinate joint activities and facilitate the standardization, sharing of data, sharing and banking of specimens, including a web data management system with facilities for data entry, editing, updating and storage;6) collaborate In monitoring study conduct including feedback and reporting to the Steering Committee and regulatory bodies, as required;7) monitor emerging results and data quality, and prepare Interim analysis reports for the Data and Safety Monitoring Board (DSMB);8) coordinate meeting logistics, and to coordinate manuscript preparation;9) collaborate on the final analyses of the data based on optimal statistical methods, and in the presentation and publication of results;10) to prepare final documentation and provide datasets to the centers, or to external investigators;11) To manage resources for an efficient and productive collaborative research network.
|Morris, Alison; Beck, James M; Schloss, Patrick D et al. (2013) Comparison of the respiratory microbiome in healthy nonsmokers and smokers. Am J Respir Crit Care Med 187:1067-75|