The Biostatistics Core at Mayo Clinic provides statistical collaboration and data management support for the development, conduct and analysis of research studies across Mayo Clinic. The Biostatistics Core is made up of over 200 specialized staff who support more than 2,000 ongoing institutionally and nationally funded investigations and a multitude of research programs. The Biostatistics Core often works within the following areas:
The Biostatistics Core provides clinical statistics built upon a model of collaboration introduced by Dr. Joseph Berkson (known as the Berkson error model). Biostatistics Core members collaborate on thousands of ongoing projects ranging from incidence studies supported by the Rochester Epidemiology Project to data and statistical coordinating centers for multisite clinical trials.
The clinical statistics area provides core statistical support for a number of program projects and National Institutes of Health-funded research programs. This area is tightly integrated into Mayo Clinic's Center for Clinical and Translational Science (CCaTS), a member of the national Clinical and Translational Science Awards Program, as well as the many clinical departments within Mayo Clinic. The group has a rich continuing education program with monthly journal clubs and book reviews.
Cancer center statistics
The Biostatistics Core collaborates with the Mayo Clinic Cancer Center — Research to provide statistics for the design and conduct of cancer clinical trials, other peer-reviewed clinical and translational research not involving high-dimensional data, such as immunohistochemistry, single or small gene sets as prognostic markers, and educational research generated by Mayo Clinic Cancer Center — Research investigators, including supporting the cancer prevention network and the Early Cancer Therapeutics Group.
Biostatistics Core team members also staff the Statistics and Data Center for the Alliance for Clinical Trials in Oncology, one of the four NCI-funded national clinical trials networks for the conduct of phase II and III cancer clinical trials. The group also leads statistical collaboration activities for the Academic and Community Cancer Research United (ACCRU) network of multicenter oncology trials and provides similar activities for the work of the Alliance Foundation Trials.
The core's statisticians are organized into specific disease-oriented groups, for example, gastrointestinal and breast. Disease-site-specific knowledge gained by this organization effectively promotes tight collaboration and success. Groups consist of statisticians with master's degrees and statistical programmer analysts. The groups meet monthly to discuss systems, procedures and policies, and quarterly to discuss new analytical approaches as well as statistical methodology.
Methodology expertise is extensive and includes: survival analysis, all phases of clinical trial design (including innovative approaches to phase I design), biomarker-based clinical trials, assessment and validation of surrogate endpoints in oncology, and assessment of patient-reported outcomes, with much of this work extramurally funded.
The Biostatistics Core also provides analytical and informatics expertise to researchers engaged in genetics, genomics, proteomics and metabolomics studies. This group provides study design and analytical and interpretative support to investigators at Mayo Clinic's campuses in Minnesota, Arizona and Florida and maintains state-of-the-art expertise in relevant methods for extracting information and knowledge from "omics" data. The statisticians and statistical programmer analysts have expertise covering transcriptome, epigenome, exome and whole-genome sequencing projects for family studies, case-control studies, cohort studies and prognostic studies. The computational genomics group provides infrastructure, pipelines and guidelines to the division members for all omic studies.
Clinical informatics services
Clinical informatics services (CIS) includes comprehensive data consultations, timely and accurate data acquisitions using Mayo Clinic's electronic medical record, and affordable electronic data capture (Rave, SDMS, REDCap) development services.
Data retrieval specialists
Data retrieval specialists identify cohorts and provide data extractions for approved Institutional Review Board (IRB) research, and legitimate non-IRB purposes, while providing full compliance with HIPAA regulations, state law and Mayo Clinic's policy regarding use and disclosure of that data. Data retrieval specialists have extensive knowledge of existing data sources, the data elements the sources contain, and the methods used to extract or retrieve the data.