Assuring Statistical Validity and Accurate Analyses
Valid statistical interpretation of most clinical trials relies on valid inference from multiple statistical analyses.
When more than one analysis yields “statistically significant” results, the overall false positive rate for sets of multiple analyses can inflate above acceptable levels, typically 5%.
This issue is referred to as “multiplicity” and can occur from analyses of several endpoints, multiple time points, multiple populations, and/or several “looks” at analysis results of the same endpoint after different amounts of data have been collected.
Our Project Teams
Cytel has clinical trial statisticians with extensive knowledge and experience in clinical trial methodology related to designing clinical trials and analyzing data to address multiplicity issues.
Cytel has experience across all therapeutic areas designing and implementing better clinical trials. In every phase of development we've helped trial sponsors in oncology, cardio-vascular, CNS, gastro-intestinal, Diabetes, metabolic disorders, inflammatory, pain, psychiatric, rare/orphan diseases, and medical devices.