Core C: Biostatistics and Data Management

Project Summary/Abstract The Biostatistics and Data Management (BDM) Core is responsible for all statistical and data management activities for each of the Myeloproliferative Neoplasm Research Consortium (MPN-RC) projects including all clinical trials. Each of the projects presented in this application reflects input from the Director of the BDM Core (Dr. Amylou Dueck, Mayo Clinic) on the design, data management, and biostatistical analysis plan. The BDM Core is constituted to provide state-of-the-art statistical collaboration and data management support to all clinical and translational research projects. The biostatistical and data management components of this Core are integrated at Mayo Clinic under the leadership of Dr. Amylou Dueck, who is also the Director of the Biostatistics Shared Resource of the entire Mayo Clinic Cancer Center which spans across Minnesota, Arizona, and Florida. The Core will provide statistical expertise including experimental design for laboratory studies, statistical modeling, analysis of high- dimensional data, analysis of patient-reported outcomes, design and analyses of correlative studies using biospecimens, and sound clinical trial design, monitoring, and analysis. The Core will also provide state-of-the-art web-based data management through Mayo Clinic's data management infrastructure with all clinical trial, biomarker, and tumor bank data captured in Medidata Rave. This web-based system provides ease of use coupled with an integrated randomization module (Medidata Balance), app-based electronic patient questionnaires (Medidata Patient Cloud), custom reporting, robust data validation routines, and straightforward integration with SAS for seamless overall statistical analysis. Dr. Dueck is an experienced co- investigator on translational and clinical research program grants in hematologic malignancies with extensive collaborations with the MPN-RC investigators. The competencies of the biostatistical and data management components of this Core provide the full spectrum of expertise and operational capacity needed to actively collaborate with the translational and clinical investigators in the formulation of the research protocols, in implementation according to internationally-accepted requirements, and in the statistical analysis of the data from clinical, laboratory, and translational studies. The BDM Core is a critical component of the MPN-RC.