Three Traps to Avoid

&

Bioinformatics Advantage

1.) In the Discovery Phase

Its ok to “Fish” for significant relationships in your data (i.e. look at correlations across all my variables and then report the significant ones that you find).

With alpha=0.05, after 20 correlations you can expect to make a spurious correlation. Data Mining is a bioinformatics tool, you just need to know the rules.

2.) In an Early Phase Trial

I can only afford to have 25 patients in this first

trial, I don’t need a “power” calculation.

Even when you know how many patients you can afford, changing the design slightly or balancing the study arms differently can increase your ability to observe true differences.

Model various scenarios to optimize your design.

3.) In a Phase 3 Trial

Having “enough” patients in each arm is most

important to demonstrate efficacy and safety.

Genotyping and biomarkers can identify the appropriate patient population to:

Reduce Safety Risks and

Improve Efficacy

A Boutique Statistical Consulting Firm

Serving Industry and Academia in Clinical Trials and Drug Discovery