Clinical Trials Program
The Clinical Trials Program is one of the three scientific programs of the Department of Biostatistics and Medical Informatics and currently consists of two components:
The mission of the Data Coordinating Center (DCC) is to support investigator-initiated NIH or industry-sponsored randomized controlled trials (RCTs) by providing expertise in statistical methodology and support for data management, quality control and assurance, study monitoring and communications using clinical trials data management system and other information systems. The DCC was created as a component of the Clinical Trials Program guided by the National Heart, Lung, and Blood Institute’s Data Coordinating Centers’ Best Practices and its Compendium.
The mission of the Statistical Data Analysis Center (SDAC) is to promote high quality conduct of clinical trials. For over 20 years, we have set a gold standard for clinical trial interim monitoring by supporting Data Monitoring Committees through innovative statistical analysis and reporting. We have experience with a wide range of phase 2/3/4 clinical trial designs in multiple therapeutic areas. We remain a leader in this field, creating comprehensive yet easily interpretable DMC reports and actively participating in the development of DMC operating procedures to encourage best practices for interim monitoring.
Our goal is to improve the quality of clinical trials at the University of Wisconsin-Madison and elsewhere by having published resources and activities available concerning clinical trial methodology and results. Fulfilling this goal includes authoring and co-authoring textbooks and peer-reviewed publications, holding Brown Bag Seminars, and participating in professional meetings. The Department is involved with a Capstone Certificate in Fundamentals of Clinical Research and MS and PhD degrees in Clinical Investigation by providing instructional resources for the following course offerings: BMI 541: Introduction to Biostatistics; BMI 542: Introduction to Clinical Trials I; BMI 544: Introduction to Clinical Trials II; and BMI/Stat 641: Statistical Methods for Clinical Trials.
Faculty and staff offer expertise in clinical trial planning, conduct, analysis and reporting and collaborate with clinical investigators from many departments, centers, and institutes and through the Wisconsin Network for Health Research (WiNHR), Midwest Area Research Consortium for Health (MARCH), and Greater Plains Collaborative Clinical Data Research Network (GPC CDRN).