Patient Recruitment and Data Analysis

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The Patient Recruitment and Data Analysis Core (PRDAC) is an assembly of experienced investigators, staff, and material resources that will provide vital infrastructure support to this Asthma and Allergic Diseases Cooperative Research Center (AADCRC) application. The PRDAC is headed by Dr. Jerry A. Krishnan, MD, PhD, Associate Professor of Medicine and Epidemiology, Director of the Department of Medicine Data Management and Statistics Core, and a board-certified pulmonary physician with expertise in clinical investigation in asthma. Dr. Dan Nicolae, PhD, Associate Professor of Human Genetics and Statistics, will be the lead statistician in the PRDAC and will serve as core co-Leader. The PRDAC will be responsible for managing the recruitment of participants for the clinical studies as well as the performance of high quality data management and statistical analysis functions for this AADCRC application. Participant recruitment is one of the most demanding aspects of clinical studies and the expertise and resources it requires are frequently underestimated. We are currently recruiting subjects for multiple NIH-funded studies in airway disease and this work has allowed us to develop the appropriate expertise and an understanding of the resources needed to successfully screen, approach, and enroll study subjects, to collect clinical, physiologic, and biological data (including airway specimens from bronchoscopy) using research protocols, and to perform high-quality data management/statistical analysis. We have taken advantage of this collective experience in designing the proposed PRDAC and PRDAC budget. The three projects will recruit from a common pool of patients with asthma. Therefore, we elected to coordinate our recruitment efforts through the PRDAC to: 1) eliminate the need to duplicate or to compete for recruitment-related resources, thereby improving the efficiency with which our investigators meet enrollment targets, and 2) ensure that a uniform baseline characterization of asthma is employed across projects, permitting the opportunity for cross-study syntheses of findings. The PRDAC will be responsible for coordinating and developing reports for patient recruitment and human subjects research activities for our Data Safety and Monitoring Plan for review by the University of Chicago IRB and by the NIAID Project officer. In addition, the PRDAC will collaborate with project leaders and co-investigators within other projects/cores to ensure a timely transmission of findings via reports, abstracts, and manuscripts. The PRDAC, therefore, will facilitate the efficient and successful completion of studies proposed in each project and promote the synthesis and dissemination of knowledge gained across the various studies.