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 11 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.

Comparing Treatments to Optimize Outcomes

Only approximately 30% of patients who need a potentially life-saving transplant to treat blood cancer like leukemia or lymphoma have an appropriate sibling donor. In such cases, an alternative donor is required. In a recent Fred Hutch study, our Clinical Biostatistics team collaborated with researcher-physicians to study which of several alternative donor sources should be used. The results suggested that cord blood may be a better source than mismatched unrelated donors for patients whose cancer is not fully in remission after the “conditioning” required to kill cancer cells before transplantation. These results provide the best available data to inform doctors and patients on donor selection when appropriate siblings are not available.

Our 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.

Our areas of expertise include:

  • Transplantation
  • Infectious diseases
  • Immunotherapy
  • Survivorship
  • Lung cancer
  • Breast cancer
  • Solid tumors
  • High-dimensional data analysis
  • Biomarkers
  • Clinical trial design
  • Survival analysis
     
  • Transplantation
  • Infectious diseases
  • Immunotherapy
  • Survivorship
  • Lung cancer
  • Breast cancer
     
  • Solid tumors
  • High-dimensional data analysis
  • Biomarkers
  • Clinical trial design
  • Survival analysis

Our 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.

Our biostatisticians collaborate with researchers to:

  • 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
     
  • 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
     

Our 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 (CCSS)

Biostatistics member Wendy Leisenring has led the Statistics and Data Center of the Childhood Cancer Survivor Study 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.

Learn more about CCSS

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.

Learn more about Lung-MAP

National Wilms Tumor Study (NWTS)

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.

Learn more about NWTS

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.

Learn more about Survivorship


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.

Learn more about SWOG

Contact Keith Lowe

Program Administrator