Statistical Data Analysis Center
REPRISE (2014-present) A Phase 3b, multicenter, randomized-withdrawal, placebo-controlled. double-blind, parallel-group trial to compare the efficacy and safety of tolvaptan (45 to 120 mg/day, split-dose) in subjects with chronic kidney disease between late stage 2 to early stage 4 due to autosomal dominant polycystic kidney disease. Primary outcome measures are treatment difference in the change of eGFR from pre-treatment baseline to post-treatment follow-up, normalized (divided) by each subject's treatment duration. Industry sponsored.
A 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 multi-center clinical trials. Research and demonstration project for educating students and investigators in analyzing and processing the data collected in multi-center clinical trials.
We have created two sample reports to provide examples of reports we produce for data monitoring committees (DMCs) in clinical trials. Comments are encouraged.
Sample Report: A sample DMC report using simulated trial data. Report content and layout has been modeled based on cardiovascular trials. [Revision history]