SPIROMICS GIC ABSTRACT This application proposes infrastructure support for the Genomics and Informatics Center (GIC) and assistance to the clinical sites and investigators for the multi-center Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). SPIROMICS I enrolled a cohort of 2,981 participants aged 40-80, including non-smokers and smokers with or without COPD. Data, CT images and biospecimens were collected at study visits and participants had quarterly telephone contacts, which are ongoing. A grant application to continue the study as SPIROMICS II has been reviewed and received a fundable priority score. SPIROMICS II will include an additional clinic visit and continued telephone follow-up. Because SPIROMICS I was funded through contracts from NHLBI, the biospecimens and data are the property of the federal government and NHLBI has a vested interest in ensuring that they are stored and managed appropriately. NHLBI is also committed to the science being undertaken in SPIROMICS and thus to maintaining contact with participants and supporting statistical analysis for manuscripts and the infrastructure for the study. The GIC proposes to continue to manage SPIROMICS data and biospecimens, undertake statistical analyses of study data, collaborate in operational and scientific aspects of the study, and provide study management and regulatory oversight. Our principal contributions to the study are grouped into the following specific aims: ? Aim 1: Maintenance and management of biospecimens. Ensure specimens are stored under appropriate conditions, manage the process of requesting use of specimens, and pull and ship specimens to investigators when approved by the Steering Committee and NHLBI. ? Aim 2: Study management and operational support. Schedule and facilitate meetings and conference calls, support study committees, oversee SPIROMICS policies and procedures, maintain a web site for the study, support continued contact with study participants, including by providing incentives to participants for completion of follow-up telephone calls, continue support for abstraction and adjudication of study endpoints, and provide improved systems for maintenance of CT images. ? Aim 3: Data management and statistical support. Manage and distribute study data and conduct statistical analyses for manuscripts and presentations. ? Aim 4: Regulatory oversight. Track IRB approvals, manage reporting of serious adverse events, ensure use of data and specimens is in accordance with each participant's informed consent, and report on study progress to the Observational Study Monitoring Board (OSMB). The GIC was responsible for most of these activities in SPIROMICS I. Funding this application will enable us to expand our support for the study, to upgrade procedures, particularly the data management system, and to increase capacity in terms of undertaking statistical analyses for manuscripts.
SPIROMICS GIC U24 Project Narrative SPIROMICS enrolled and has been following 2,981 people with and without COPD, aiming to find subtypes of COPD that could be targeted for development of new treatments and intermediate endpoints that could be used to reduce the length of clinical trials. SPIROMICS II will continue following this cohort, allowing longer-term outcomes to be investigated and new science to be conducted. The current application adds infrastructure support to SPIROMICS, beyond what is budgeted in SPIROMICS II, including management of the samples and data that have already been collected, support for following the cohort and for study operations, statistical analyses for manuscripts, and regulatory oversight.
