CSRN Statistics and Data Management Center

The Statistics and Data Management Center (SDMC) is led by three senior principal investigators at Fred Hutch Cancer Center who have extensive experience in multi-center trial operation in prevention, early detection and treatment. This experience in leading statistical and data operations enables us to build an SDMC that will reliably address the analytic needs of the CSRN so that it produces valid evidence about the clinical and population impact of novel early detection products. The SDMC will oversee cancer screening clinical trials enrolling diverse participants, manage and analyze the vast amounts of data generated. 

SDMC Leadership

Ziding Feng, PhD

Ziding Feng, PhD

Co-Principal Investigator, SDMC, Fred Hutch
Professor, Public Health Sciences Division, Fred Hutch
Member, Translational Data Science Integrated Research Center, Fred Hutch
Katherine A. Guthrie, PhD

Katherine A. Guthrie, PhD

Co-Principal Investigator, SDMC, Fred Hutch
Professor, Cancer Prevention Program, Public Health Sciences Division, Fred Hutch
Charles Kooperberg, PhD

Charles Kooperberg, PhD

Co-Principal Investigator, SDMC, Fred Hutch
Professor and Program Head, Biostatistics Program, Public Health Sciences Division, Fred Hutch
Member, Translational Data Science Integrated Research Center, Fred Hutch

SDMC Primary Aims

Integrate the SDMC With the Other CSRN Components

  • Along with the CCC, co-lead the network’s initial study planning for study governance and timelines, protocol and procedures development, data collection activities, ACCESS Hub training and trial monitoring.
  • Tailor study monitoring to support the CCC with recruitment tracking, biospecimen management and progress on data collection.

Provide Rigorous and High-Quality Design and Analysis

  • Develop designs for MCD trials that balance screening frequency, trial duration, and sample size to achieve adequate statistical power given cost constraints.
  • Provide statistically rigorous and interpretable analyses of trial data, including interim and final analyses and, where appropriate, analyses of intermediate endpoints.
  • Provide clear and timely reporting to the Data Safety and Monitoring Board.

Build a State-of-the-Art Data System to Ensure Data Quality and Integrity

  • Maximize data accuracy by creating case report forms that are easy to understand and include comprehensive and informative edit checks.
  • Standardize coding and database structures to enable scalable, efficient activation, evaluation and reporting of new or substantially modified CSRN trials. 

Develop Statistical and Data Management Approaches

  • Delineate key elements of the Vanguard study design to ensure collection of preliminary data.
  • Leverage evidence gained from the Vanguard trial to design a scientifically sound and efficient large clinical trial.
  • Prepare innovative solutions for scaling up data systems to ensure continued excellence in data quality.
     

SDMC Co-Investigators

David Carrell, PhD

David Carrell, PhD

Consultant, SDMC
Associate Investigator, Washington Health Research Institute, Kaiser Permanente Washington
Affiliate Associate Professor, Biomedical Informatics and Medical Education, University of Washington School of Medicine
Ruth Etzioni, PhD

Ruth Etzioni, PhD

Co-Prinicipal Investigator, SDMC, Fred Hutch
Professor, Cancer Prevention Program, Public Health Sciences Division, Fred Hutch
Member, Translatonal Data Science Integrated Research Center, Fred Hutch
Rosalie and Harold Rea Brown Endowed Chair, Fred Hutch
Antje Hoering, PhD

Antje Hoering, PhD

President, Board Chair and CEO, Cancer Research and Biostatistics (CRAB)
Consortium Principal Investigator, SWOG
Affiliate Professor, Fred Hutch
Affiliate Professor, Biostatistics Department, University of Washington
Ying Huang, PhD

Ying Huang, PhD

Professor, Biostatistics, Bioinformatics and Epidemiology Program, Vaccine and Infectious Disease Division, Fred Hutch
Professor, Public Health Sciences Division, Fred Hutch
Member, Translational Data Science Integrated Research Center (TDS IRC), Fred Hutch
Catherine Tangen, DrPH

Catherine Tangen, DrPH

Professor, Public Health Sciences Division, Fred Hutch

Frequently Asked Questions

  • Dr. Charles Kooperberg will be the contact PI of the SDMC. He will be the primary liaison to the CSRN Steering Committee, Coordinating and Communication Center (CCC), ACCESS Hubs, and NCI. Dr. Kooperberg will be responsible for overall study management, oversight, and analysis planning.
  • Dr. Katherine Guthrie will oversee data operations and management. She will be the investigator primarily responsible for reporting to the Data and Safety Monitoring Board.
  • Dr. Ziding Feng’s primary responsibility will be the statistical aspects of design, analysis, and interpretation of CSRN studies.
     

The CSRN SDMC’s data management and computing components will be housed at Cancer Research and Biostatistics (CRAB), as they are for the SWOG SDMC. CRAB is an independent non-profit cancer research organization with the mission to prevent and cure cancer using statistical methods and technologies to optimize cancer research assuring the highest research quality and data integrity. For the SWOG SDMC, CRAB collects, manages and maintains trial and correlative data in the CRAB data center for all clinical trials (200+), including the NCI’s Lung-MAP project. CRAB is situated less than a mile from Fred Hutch.

As a cancer screening trials network, the CSRN will conduct multi-center trials of early detection modalities. Therefore, the statistical approach to CSRN studies will incorporate established design and analysis methods for multi-center clinical trials while incorporating the special considerations of screening trials, such as:

  • Standard screening trial design and analysis for the primary endpoint of disease-specific mortality.
  • Accommodating non-compliance.
  • Non-constant mortality rate ratio.
  • Shortening trial durations: potential surrogate endpoints.
  • The role of modeling

SDMC Suppport Team

Amy Darke, MS

Staff Statistician

Phyllis Goodman, MS

Statistical Analysis Manager

Melissa Plets, MS

Staff Statistician

Jeannette Schenk, PhD, MS, RD

Project Director

Dani Weatherbee

Applications Development Project Manager

Eric Woodruff

Research Administrator