UW-Madison, Biostatistics & Medical Informatics

Biostatistics and Medical Informatics Clinical Trials Statistical Data Analysis Center
	printable pdf page
	Vision Statement of Statistical Data Analysis Center
	Leader in promoting statistical practice, applications, and research in the design and analysis of clinical trials especially in the preparation of Data Monitoring Committee reports necessary to evaluate the accumulating evidence for safety and efficacy. Mechanism for supporting University of Wisconsin investigators conducting cutting edge research through multicenter clinical trials. Research and demonstration project for educating students and investigators in analyzing and processing the data collected in multicenter clinical trials.	UW Madison, WARF Building, SDAC
	Research Portfolio
	Ongoing Trials, Completed Trials with Ongoing Publications, Completed Trials and Publications
	Sample DMC Report and Report Production Overview
	Sample Report : A sample DMC Report using publicly available clinical trial data from the Beta-Blocker Heart Attack Trial (BHAT) prepared by SDAC, is provided as a sample. We encourage comments on additional informative graphics. Report Production Overview: For more information regarding the SDAC-style DMC reports, see our Society for Clinical Trials 1999 Meeting contributions including the paper, "Report Production for a Data and Safety Monitoring Board - A UNIX Based System for Report Generation", describes our report production process in more detail. The poster, "A Sample Report for a Data Monitoring Board", with a text slide describing the content of a typical interim analysis DMC report, and a paper on "Sequential Monitoring of Multiple Endpoints in Clinical Trials."
	Selected DMC Charter and Selected DMC Background Material
	Sample DSMB Charter (based on Diabetes Control and Complications Trial) Data Monitoring Committees: Lessons, Ethics, Statistics Study Group. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 365:711-22, 2005 Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committee accessible at www.fda.gov/cber/gdlns/clintrialdmc.htm issued March 2006 The role of an Independent Statistical Analysis Center in the Industry-Modified National Institutes of Health Model by Fisher, Roecker, and DeMets. Drug Information Journal 35:115-129, 2001.