Clinical Biostatistics

The clinical researchers at Fred Hutch relentlessly pursue the best outcomes for our patients. We continually develop innovative, experimental therapies and seek approaches to improve cancer treatment and care.

The statisticians in the Clinical Biostatistics program are instrumental in designing and analyzing data from the experiments that drive our clinical research. Our team of statisticians collaborates extensively with the clinical investigators in the division. We lead the design, analysis, and interpretation of results from studies to obtain the most accurate, evidence-based scientific conclusions to best inform patient treatment and care.


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Available Expertise & Services  |  Accessing Our Services  |  Collaborations

Available Expertise and Services

Ted Gooley, Director of the Clinical Biostatics team, holds a meeting with team members in his office at the Fred Hutchinson Cancer Research Center

Clinical Research Expertise

The biostatisticians in our group maintain deep content expertise in a variety of biological, clinical, and statistical disciplines, so we can best advise our clinical collaborators on the conduct of disease-specific experiments and clinical trials.

  • Transplantation
  • Infectious Diseases
  • Immunotherapy
  • Survivorship
  • Lung Cancer
  • Breast Cancer
  • Solid Tumors
  • High-Dimensional Data Analysis
  • Biomarkers
  • Clinical Trial Design
  • Survival Analysis
Statistician and mathematician Tim Randolph, right, works with Isaac Jenkins in the Clinical Biostatistics Department at the Fred Hutchinson Cancer Research Center

Biostatistical Services

Our team helps clinical researchers conduct studies, including Phase I and Phase II clinical trials, which identify the appropriate dose of an experimental drug to study for potential efficacy. We also guide observational studies, where we analyze data that have already been collected outside the context of a clinical trial.

  • Develop Testable Hypotheses
  • Determine Sample Sizes and Power for Studies
  • Randomize Study Populations When Appropriate
  • Select Statistical Methodology for Data Analysis
  • Specify Data Collection Procedures
  • Identify Appropriate Endpoints in Study Design
  • Design Prospective and Retrospective Clinical Studies

Clinical Research Expertise

  • Transplantation
  • Infectious diseases
  • Immunotherapy
  • Survivorship
  • Lung cancer
  • Breast cancer
  • Solid tumors
  • High-dimensional data analysis
  • Biomarkers
  • Clinical trial design
  • Survival analysis
     
  • Develop testable hypotheses
  • Determine sample sizes and power for studies
  • Randomize study populations when appropriate
  • Select statistical methodology for data analysis
  • Specify data collection procedures
  • Identify appropriate endpoints in study design
  • Design prospective and retrospective clinical studies
     

Accessing Our Services

The Consortium's Biostatistics Shared Resource provides collaborative statistical support to investigators and research projects. While the majority of the activities of this shared resource will go to support research trials, this expertise can be utilized by any Consortium member requiring biostatistics support, regardless of whether it is related to a research trial. 

Our goal is to foster long-term collaborations between biostatisticians and other scientists in all phases of the research process. During the design phase, the statistician assists with such things as study design, selection of primary and secondary endpoints, sample size and power calculations, data collection instruments, and early stopping criteria. After a study is complete, the statistician assists in data analysis, interpretation of results, and preparation of manuscripts. The Consortium's Biostatistics Shared Resource recognizes a need to help with Investigator-Initiated Trials. 

Currently we do not offer consultation on a "fee for service" basis. Support for small projects and the development of new projects is underwritten with funds from the NCI CCSG. Historically our services have prioritized junior investigators who do not yet have established funding. Continuing collaborations above a nominal level of effort are expected to be funded through grants and contracts. Appropriate funding levels can be determined during development of a project proposal. 

I am interested in Clinical Biostatistics services.

Multicenter and Multidisciplinary Collaborations

Fred Hutch directs the statistical component of multiple long-term epidemiologic cancer studies nationwide. We also lead the design and analysis of several cross-disciplinary, institution-wide initiatives conducted by researchers at Fred Hutch.

Childhood Cancer Survivor Study

Biostatistics member Wendy Leisenring has led the Statistics and Data Center of the Childhood Cancer Survivor Study (CCSS) since 2004. A multicenter collaborative study started in 1994, CCSS tracks nearly 36,000 childhood cancer survivors from 31 treatment centers across the country. The aim of the study is to improve cancer treatment by understanding the behavioral, genetic and treatment-related factors that influence the risk of long-term complications that children treated for cancer can develop. These include secondary cancers, organ dysfunction, reduced growth and fertility, and early death.

Survivorship Program

The Survivorship Program at Fred Hutch conducts research to learn more about the long-term and late effects of cancer treatment and to improve the quality of life for survivors. Survivorship studies range from examining the long-term cardiovascular effects of chemotherapy to investigating the factors that determine emotional adjustment and improve quality of life after cancer. The biostatisticians in our program are instrumental in designing studies and analyzing data that informs our approach to long-term and follow-up treatment

LungMAP

Associate member Mary Redman is the lead statistician for the Lung-MAP trial. Lung-MAP is a first-of-its-kind nationwide clinical trial model to treat advanced squamous cell lung cancer. It uses a novel, multi-drug, targeted screening approach to match patients with studies testing investigational new treatments based on their unique tumor profiles. Lung-MAP is an innovative partnership among patient advocacy organizations, the National Cancer Institute, pharmaceutical companies, and a nationwide network of treatment centers.

SWOG Cancer Research Network

Founded in 1956, the SWOG Cancer Research Network is a global cancer research community that designs and conducts publicly funded clinical trials at more than 1,000 centers worldwide. SWOG’s aim is to improve lives by testing new treatments, prevention strategies, and ways to care for people who survive cancer. Fred Hutch oversees the group’s Statistics and Data Management Center, which provides expertise in the design, implementation, monitoring, analysis, and interpretation of SWOG trials, as well as studies that aim to translate laboratory findings into patient treatment. Clinical biostatistics associate member Mary Redmond serves as the lead statistician for the SWOG Lung Committee.

National WILMS

Biostatistics member Wendy Leisenring serves as Principal Investigator of the National Wilms Tumor Late Effects Study. The original NWTS trials aimed to improve the survival of children with Wilms and other rare kidney tumors. Children from more than 250 pediatric oncology treatment centers around the country participated. Although NWTS no longer conducts clinical trials, they continue to follow patients learn about their long-term health and investigators continue to analyze the collected data. The goal is to understand the long-term effects of various treatment approaches, so doctors and patients can make better treatment decisions for their long-term survival and quality of life.

Contact Us

Emily Jo Artim

Emily Jo Artim

Program Administrator