A Comprehensive Cancer Center Designated by the National Cancer Institute

Pathways to Discovery: Summer 2013

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Focus on: Core Facilities

Biostatisticians Work with Cancer Researchers to Optimize Study Design

At the University of Chicago Medicine Comprehensive Cancer Center (UCCCC), investigators have access to a shared resource, the Biostatistics Core Facility, which provides advice on research design, data analysis, and statistical analysis.

“Biostatistics is a key part of the collaborative science involved in cancer research,” said Ronald Thisted, PhD, professor of health studies and scientific director of the Biostatistics Core Facility. “We help design state-of-the-art studies that extract the maximum amount of information possible.”

The types of studies that benefit from statistical support include investigatorinitiated Phase I, II, and III clinical trials; observational and population-based studies; basic science research projects; animal experiments; and correlative/translational studies.

Designing any study requires careful planning. “The more we can understand what investigators need, the better we are able to help them carry out a successful investigation,” Dr. Thisted said. “It’s a back and forth discussion of asking ‘why’ and ‘how.’”

He added that studies are more successful when researchers involve the Biostatistics Core Facility in the early stages of formulating their study protocol or grant proposal. For example, when planning a Phase II clinical trial, which is intended to evaluate a treatment’s effectiveness, investigators need to ascertain and decide upon many factors, including how many patients to include, the study design (for example, single arm vs. randomized), and which endpoints to use. The Facility also helps researchers write protocols, which may be adopted by multiple physicians in affiliated hospitals who participate in the Phase II Oncology Trials Network.

The Facility plays an essential role in helping investigators to analyze research data, which is shared with the oncology community at national meetings and in scientific journals. The Facility’s Technical Director and Research Associate (Associate Professor) of Health Studies Theodore Karrison, PhD, said, “We believe in evidence-based medicine, so if a new therapy needs to be evaluated, we help investigators design the studies and analyze the data to produce evidence about the treatment’s safety and efficacy.”

The Facility interacts closely with the UCCCC Cancer Clinical Trials Office to ensure the accuracy, timeliness, and quality of research data. The Facility also works with the newly developed Bioinformatics Core Facility to provide comprehensive design and analytical services to investigators working on experiments that generate large sets of molecular data, e.g., microarray and high-throughput DNA sequencing data.

“Biostatistics is a very collaborative enterprise,” said Dr. Thisted. “Ultimately, the goal of statistics is to make the results clearer. We have a really great team of experts who can do this.”