Core C: Biostatistics and Data Management Core

CORE C Abstract The Biostatistics and Data Management (BDM) Core is responsible for all statistical and data management activities for each of the Myeloproliferative Neoplasms Research Consortium (MPN-RC) projects and cores including all clinical trials and the tumor bank. 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. Dr. Dueck and her team are highly published in the MPN field and notable experts in MPN clinical trial design and statistical analysis of patient outcomes. The Core will provide statistical expertise including experimental design for laboratory studies; statistical modeling; statistical analysis of high-dimensional data, patient-reported outcomes, and correlative studies using biospecimens; and state-of-the-art clinical trial design, monitoring, and statistical analysis within an efficient platform protocol. The Core will also provide advanced web-based data management through Mayo Clinic’s data management infrastructure with all clinical trial and tumor bank data captured in REDCap. This web-based system provides ease of use coupled with electronic patient questionnaires, online calendaring/querying/tracking, robust data validation routines, and straightforward integration with SAS/R 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.