CRAB, in partnership with the Fred Hutchinson Cancer Research Center, is the Statistical Center for SWOG, one of the largest of the National Cancer Institute-supported cancer clinical trials cooperative groups. SWOG’s primary mission is to improve the practice of medicine in preventing, detecting and treating cancer. The mission is accomplished through the mutual efforts of the Group Chair’s Office in Ann Arbor, Michigan, the Operations Office in San Antonio, Texas, the Statistical Center in Seattle, Washington and the dedicated oncology professionals in the institutions of the Group.
As the Statistical Center, CRAB participates in the design, support, and analysis of trials to address important hypotheses in cancer treatment and prevention, and in the translation of biologic concepts to clinical care. Quality research, quality data, and the publication of results are critical to this effort. Approximately 100 clinical trials are underway at any given time. On average, 5,000 cancer patients and healthy participants are enrolled each year and 30,000 more are involved annually in ongoing clinical trials.
The Statistical Center at CRAB contributes through the following.
Study Design
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.
Protocol Review
The Statistical Center reviews all protocols for logical consistency, completeness, and design integrity to assure that study conduct is not compromised through use of an inaccurate protocol document.
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.
Data Quality Control and Monitoring
The Statistical Center 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.
Software Development and Maintenance
The Statistical Center is responsible for creating and supporting many custom software applications used by the institution membership, as well as internal staff at the Statistical Center, Group Chair’s Office, and Operations Office. Staff also evaluate and utilize commercial software products as applicable. These applications support the research and goals of SWOG, including data collection, data management, data retrieval and analysis.
Information Technology
The Statistical Center evaluates, develops and maintains state-of-the-art information technology to support its objectives. The Information Technology staff provide and sustain hardware support for computer processing and storage of data.
Analysis and Publication
The Statistical Center is responsible for statistical analysis and interpretation of all SWOG studies. Biostatisticians analyze and publish the results of studies in conjunction with the Study Coordinators (principal investigators).
Statistical Research
The Statistical Center has an active research program addressing ongoing design and analysis issues important to the conduct of cancer clinical trials and to ancillary biologic studies.
Education and Collaboration
The Statistical Center plays a key role in the training of new Clinical Research Associates (CRAs) and of Young Investigators in the Group. 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.
Communications
Statistical Center staff work with the 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.