Gaston Lab Research Cores

The administrative core oversees the coordination of the P01 project and core activities. Specifically, it is in charge of supervising the organizational structure and chain of responsibility. Weekly lab meetings, monthly program-wide meetings, annual internal advisory board meetings and annual external advisory board meetings are coordinated and documented through this core. An annual speaker series is also coordinated by the core, in conjunction with advisory board meetings. The core maintains records, interfaces with program officers, the FDA, IRBs, DSMBs, and maintains this website. The core ensures optimal interactions between component projects and cores, and between the program and other relevant institutional programs. The core supervises the proper and thorough execution of the data safety monitoring plan and ensures that diversity targets are met. The core ensures proper dissemination of information and resources acquired by the group.

The Research Bronchoscopy and Biospecimens Core is responsible for performing bronchoscopy on study subjects to obtain all the necessary lung specimens for in vitro experiments. This includes collecting all the appropriate control specimens at the time of study. This core is also responsible for processing specimens in such a way that they can either be used real time or stored appropriately for future use. This includes coordination of processing and storage protocols between labs. By providing uniform specimens to all investigators the core can ensure interdisciplinary integration of the multiple projects conducted by the group.

The Clinical Studies Core, staffed with experienced individuals who are experts in their respective fields, is an integral component of the Gaston P01 program, designed to facilitate the conduct of clinical trials outlined in the three individual projects through economy of scale and coordinated resources. Specific objectives of the Clinical Studies Core are to assist investigators in accessing, selecting, recruiting, and retaining asthma subjects and healthy volunteers; to assist in planning, development, and execution of clinical projects according to good clinical practices; to manage IRB and regulatory submissions along with post-approval tasks; and to provide oversight and/or performance of tests, procedures, collection and processing of human specimens. Additionally, this core facilitates the translation of discoveries made by basic science investigators into clinical investigation, assists investigators by entering clinical study data into a team-accessible Part 11 compliant database, maintains a bank of data, tissues and samples collected from current and former patients/subjects, and finally, assists investigators in data analyses and manuscript preparation. This core makes available our well-characterized asthma populations in both Indianapolis and Cleveland for clinical studies and facilitates the bench to bedside translation of ideas from our basic science laboratories. From this support, investigators can generate hypotheses that are in turn returned to basic science laboratories for more detailed investigation.

The Primary Human Airway Cell Culture Core collects, grows, stores and expands airway epithelial cells and smooth muscle cells. These cells will come from upper airway and bronchoscopic biopsies (brush biopsies for epithelial cells and endobronchial biopsies for smooth muscle cells) obtained in conjunction with the other cores. The main site for collecting, growing and storing the cells is IU School of Medicine, but there are satellite cores at Case Western Reserve University (Cleveland) and National Jewish Health (Denver) which grow cells and conduct experiments. Cells are provided to investigators at all project sites for use in their aims, as described. This allows analysis of the relationship between clinical phenotype, drug response, genotype (for Project 3) and airway cell behavior. A long-term biobank of cells are maintained by this core at IU School of Medicine. The ability to collect, expand and distribute airway epithelial cells to researchers has a huge positive impact on understanding and developing therapies for common airway diseases.

The Pulmonary Biostatistics Core provides investigators from each project all facets of statistical support, including experimental design, analysis and interpretation. Core personnel interact with Gaston lab group investigators in all stages of research, including the formulation of research questions and hypotheses, experimental design, data management, data analysis, result interpretation, preparation of scientific manuscripts and grants, dissemination of results, and the assessment of stepwise success and barriers to meeting overall project objectives. Specific aims are: (1) to collaborate with project investigators to ensure that all clinical and translational studies and experiments are properly designed, and (2) to provide support to project investigators in the statistical analysis and reporting of data from experiments and clinical studies.