SWOG & CRAB Collaboration

Providing Statistics and Data Management Support for SWOG

CRAB, in partnership with the Fred Hutch Cancer Center, operates as the Statistics and Data Management Center (SDMC) for the SWOG Cancer Research Network, a global cancer research community of over 12,000 members in 47 states and six foreign countries who design and conduct publicly funded clinical trials. Since 1956, SWOG trials have led to the approval of 14 cancer drugs, changed more than 100 standards of cancer care, and saved more than 3 million years of human life. The group is a proud member of the National Cancer Institute’s National Clinical Trials Network and the NCI Community Oncology Research Program and is a major part of the cancer research infrastructure in the U.S. and the world. SWOG is headquartered at the Knight Cancer Institute at Oregon Health & Science University in Portland, OR, and its Network Operations Center is located in San Antonio, Texas.

The SDMC operates under the leadership of Mike LeBlanc, PhD, SWOG Group Statistician and Director of the SWOG Statistical Center, located at Fred Hutch, in Seattle, WA. As SWOG’s data management partner, CRAB, under the leadership of Antje Hoering, PhD, CRAB President and CEO, is responsible for data management and electronic data capture for all SWOG trials.

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Biostatisticians participate in the development of proposed protocols, particularly in regards to experimental design, sample size and feasibility. Biostatisticians also perform statistical research on the efficient design, conduct and analysis of cancer clinical trials and cancer control research, with special emphasis on designs for translational studies.

Biostatisticians and Data Coordinators provide independent internal review of study protocols with respect to the appropriateness of the design and data collection for the scientific aims, for consistency with general guidelines, and for clarity of eligibility and other study requirements.

The SDMC evaluates, develops and maintains state-of-the-art information technology to support its objectives. The Information Technology staff provides and sustains hardware support for computer processing and storage of data.

Our Application Developers are responsible for creating and supporting many custom software applications used by the institution membership, as well as internal staff at the Statistics and Data Management Center (SDMC) and Network Operations Center. Staff also evaluate and utilize commercial software products as applicable, including Medidata Rave as our primary electronic data capture system. All of our applications support the research and goals of SWOG, including data collection, data management, data retrieval and analysis.

The SDMC collects, reviews, manages and stores data from all active SWOG studies, and follows quality control and review procedures which ensure the integrity of the data evaluation. Data managers and statisticians collaborate with sites to ensure study data is complete, accurate and available for analysis in real time. We are responsible for statistical analysis and interpretation of all SWOG studies. Biostatisticians analyze and publish the results of studies in conjunction with the Study Chairs (principal investigators).

SWOG is a world leader not only in the quality of its research but in innovations in the conduct of clinical trials. This knowledge is shared with group members and collaborators beyond our borders.
The SDMC has an active statistical research program addressing ongoing design and analysis issues important to the conduct of cancer clinical trials and to ancillary biologic studies.
SDMC staff work with the SWOG Group Chair and other investigators in the Group to improve the quality of clinical trials through the use of improved data collection forms, reproducible data definitions and economical data flow, and efficient use of Statistical Center resources.
The SDMC plays a key role in the training of new Clinical Research Associates (CRAs) and of Early Stage Investigators in the Group, and enables participation from collaborators in Asia and Latin America. Biostatisticians and Data Coordinators educate investigators, nurse oncologists and CRAs in statistical analysis, research design and the utilization of the most advanced scientific and data management strategies.