Asthma, a disease defined as reversible airway obstruction, afflicts both genders, all age groups, and all racial/minority groups. The NHLBI is establishing an Asthma Clinical Research Network (ACRN) and this is a cooperative agreement application for Penn State University to serve as the Data Coordinating Center (DCC) for the ACRN. The role of the DCC in this endeavor is characterized by administrative support, biostatistical leadership, and data management support for the ACRN. Administrative support for the ACRN includes facilitating an atmosphere of scientific collaboration and cooperation between all participating individuals and institutions; establishing and promoting an effective communication, data transfer, and reporting structure among the DCC, the Clinical Centers, and the NHLBI; organizing meetings of the Steering Committee and sub- committees; overseeing the sub-contract with the laboratory performing the chemical analysis of blood samples; and coordinating the development and distribution of the study protocols and Manual of Operations. Biostatistical leadership for the ACRN includes comparing the merits of potential experimental designs; proposing optimal experimental designs; selecting homogeneous study groups and implementing methods to remove systematic bias; projecting appropriate sample sizes to achieve the stated clinical objectives; selecting a method of randomization; ensuring that pharmaceutical formulations or other types of treatment are masked in a sufficient manner; monitoring quality control of chemical assays; providing the Steering Committee and External Advisory Committee with interim and final data summaries and biostatistical analyses; and collaborating on the presentations at professional meetings and the submission of manuscripts for publication. Data management support for the ACRN includes developing a distributed data system for data entry at the Clinical Centers and transmission to the DCC; providing a system for subject enrollment, randomization, and data collection; designing the data collection forms; developing a system for tracking subjects, compliance, data, and blood specimens; executing procedures for data security and data quality control, storage, and back-up; and reporting accrual, adverse events, and subject safety.
| Wang, Y; Tong, C; Wang, Z et al. (2015) Pharmacodynamic genome-wide association study identifies new responsive loci for glucocorticoid intervention in asthma. Pharmacogenomics J 15:422-9 |
| Dunn, Ryan M; Lehman, Erik; Chinchilli, Vernon M et al. (2015) Impact of Age and Sex on Response to Asthma Therapy. Am J Respir Crit Care Med 192:551-8 |
| Brehm, John M; Ramratnam, Sima K; Tse, Sze Man et al. (2015) Stress and Bronchodilator Response in Children with Asthma. Am J Respir Crit Care Med 192:47-56 |
| Israel, Elliot; Lasky-Su, Jessica; Markezich, Amy et al. (2015) Genome-wide association study of short-acting ?2-agonists. A novel genome-wide significant locus on chromosome 2 near ASB3. Am J Respir Crit Care Med 191:530-7 |
| Lambert, Allison; Drummond, M Bradley; Wei, Christine et al. (2015) Diagnostic accuracy of FEV1/forced vital capacity ratio z scores in asthmatic patients. J Allergy Clin Immunol 136:649-653.e4 |
| Duan, Q L; Lasky-Su, J; Himes, B E et al. (2014) A genome-wide association study of bronchodilator response in asthmatics. Pharmacogenomics J 14:41-7 |
| Tantisira, Kelan G; Damask, Amy; Szefler, Stanley J et al. (2012) Genome-wide association identifies the T gene as a novel asthma pharmacogenetic locus. Am J Respir Crit Care Med 185:1286-91 |
| Szefler, Stanley J; Chinchilli, Vernon M; Israel, Elliot et al. (2012) Key observations from the NHLBI Asthma Clinical Research Network. Thorax 67:450-5 |
| Tantisira, Kelan G; Lasky-Su, Jessica; Harada, Michishige et al. (2011) Genomewide association between GLCCI1 and response to glucocorticoid therapy in asthma. N Engl J Med 365:1173-83 |
| Wechsler, Michael E; Castro, Mario; Lehman, Erik et al. (2011) Impact of race on asthma treatment failures in the asthma clinical research network. Am J Respir Crit Care Med 184:1247-53 |
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