BIOSTATISTICS

Design of Studies

The TIMI Biostatistical team offers expert and comprehensive design of clinical trials from phase II to IV, using time-to-event, binary, or continuous outcomes as appropriate. We have expertise in examination of multiple doses with efficient multiple-comparisons adjusted assessments of each dose to a comparator. We can easily incorporate group sequential and adaptive elements into the design as needed. Given the more than 50 large clinical trial datasets currently available at TIMI, we are able to provide well-informed enrollment and event rate estimates for designing future cardiovascular studies. We also assist with developing Statistical Analysis Plans (SAP) and designing appropriate trial censoring rules and event definitions.

Analyses of Trials

The TIMI Biostatistical team has extensive experience in the independent analysis of clinical trial results, starting with publication of the primary trial results and then extending to all of the many secondary manuscripts. Both simple and complex models can be performed, including survival analysis, non-inferiority analysis, linear or non-linear models, mixed effects models, recurrent event models, and meta-analysis. Our statistics faculty has proficiency with building and evaluating risk scores using the many large datasets available at TIMI. We also have extensive experience in biomarker and genetic analyses, including array-based "omics" analyses.