Overview

The mission of Mayo Clinic's Division of Clinical Trials and Biostatistics, which is part of the Department of Quantitative Health Sciences, is to provide high-value analytic collaborations and research services to Mayo investigators with the overall goal of improving human health. The division accomplishes this by providing statistical support for thousands of active projects through collaborative analytic partnerships with investigators both inside and outside of Mayo Clinic.

Grounded in team science principles, division faculty and staff support research teams across all stages of the research process, from study conception and protocol development through analysis, dissemination and translation into practice. These projects can cover a wide range of disciplines, including cancer, Alzheimer's disease, respiratory specialties, cardiology, neurology, radiology, surgery, anesthesiology, nursing, and laboratory medicine and pathology.

Division staff members develop, maintain and promote state-of-the-art expertise in study design, statistical methodology, advanced analytics, predictive modeling, machine learning, data management and reproducible analytic workflows. Division staff members are active in initiatives involving study design, data acquisition, data management, advanced analyses, interpretation of findings, dissemination of results, and translation of research into clinical and operational settings. Also, they contribute to many specialized research areas, including:

• Basic science.
• Clinical trials.
• Population health.
• Translational science.

The Division of Clinical Trials and Biostatistics is composed of doctoral-level statisticians, as well as biostatisticians, data science analysts and statistical programmers, with members based at Mayo Clinic's campuses in Arizona, Florida and Minnesota. The division's unique collaboration model emphasizes the importance of disease area knowledge in the design and analysis of research studies by embedding a dedicated statistical team into the research groups that the team supports.

These teams function as scientific collaborators and contribute intellectually throughout the lifecycle of a project, including study design, protocol development, statistical analysis planning, interpretation of findings, manuscript development and grant preparation. The teams bring complementary expertise in study design, statistical analysis, advanced data science methods, machine learning, predictive modeling, data engineering and reproducible workflows to support a wide range of research, clinical and operational initiatives. This highly effective model has led to the division's successes in obtaining and supporting several large, multiyear federal grants for research, including:

• The secondary use of electronic health records to identify surgical complications.
• The connection between traumatic brain injury and Alzheimer's disease.
• Mechanisms of low-frequency electroencephalography (EEG) for focal epilepsy.
• Mayo's Core Center for Clinical Research in Total Joint Arthroplasty (CORE-TJA).
• Mayo's Alzheimer's Disease Research Center.
• Frontiers in congenital disorders of glycosylation.
• Sex-specific effects of endocrine disruption on aging and Alzheimer's disease.

Early and sustained engagement with division faculty and staff is strongly encouraged. Involving quantitative experts during study conception and protocol development, before data collection and, when applicable, before grant submission, helps optimize scientific rigor, study design, sample size and power calculations, analytic plans, and overall project competitiveness.

The Division of Clinical Trials and Biostatistics also is the statistics and data coordinating center that supports investigator-initiated, multicenter cancer research programs, including:

• Alliance for Clinical Trials in Oncology.
• Alliance Foundation Trials.
• Cancer Prevention and Control Research Network.
• Six large international clinical trial databases (Sargent's Hypothesis Analysis in the Research of Endpoints, also known as SHARE).
• Specialized Programs of Research Excellence (SPORE) grants.

Division of Clinical Trials and Biostatistics faculty and staff are internationally renowned experts in many statistical methodologies and disciplines, including the design and analysis of clinical trials, advanced survival analysis methodology, categorical data analysis, risk modeling, patient-reported outcomes, quality of life, Bayesian modeling, sampling theory, quality control and causal inference. They serve on national steering committees and in professional organizations and participate in national initiatives that have major impacts on research directions in their respective areas of expertise.

Division leadership