ASTHMA CLINICAL RESEARCH NETWORK

The Data Coordinating Center (DCC) of the Asthma Clinical Research Network (ACRN) is located in the Department of Health Evaluation Sciences at Penn State's Hershey Medical Center. There are four specific goals of the DCC: 1) providing biostatistical leadership in the design, conduct, and analysis of ACRN protocols and ancillary studies; 2) providing project management and administrative support for the ACRN - its investigators, Clinical Center personnel, review committees and monitoring boards; 3) providing data management and research computing support for the ACRN; 4) establishing methods for a single DCC to conduct multiple projects and ancillary studies. The four operational units within the DCC (Biostatistics, Project Management, Data Management, and Research Computing) have unique responsibilities and objectives aimed at obtaining these goals. The DCC has established systems and procedures which lead and support the ACRN in implementing well-designed clinical trials and in collecting pristine data sets to address important issues in asthma treatment and to establish a firm clinical investigative database from which treatment decisions can be based and further hypotheses generated. In this application, we propose to continue fulfilling the specific goals outlined above, investigate and develop novel biostatistical approaches related to asthma research, expand administrative responsibilities, and increase data management module development. In the next funding period, biostatistical methods will be developed for each of the studies undertaken by the ACRN. In addition, we propose to develop new biostatistical approaches to indices of asthma control commonly used in clinical trials. Specific indices include methacholine challenge, PEFR, and daily measures which may be predictive of treatment failure. Project management responsibilities will continue in the next five years with some expansion in the area of developing and publishing standard operating procedures for managing Data Coordinating Centers. Particular emphasis Will be placed on responsibilities associated with conducting multiple protocols. During the next five years, the data management unit, in conjunction with the research computing unit, plans to enhance the function of the existing data management application modules, as well as develop new modules such as a protocol violations module. These units also plan to develop a pulmonary function database capturing the electronic transfer of all spirometry testing data, identify appropriate hardware and software to electronically scan all data collection forms and reports for storage and retrieval, and determine the feasibility of distributing additional data management processes by incorporating more edit checks during first entry of the data at the Clinical Centers.