Category Archives: Biostatistics

Calculate a “Fragility Index” to see which clinical trials BARELY meet statistical significance's Fragility Index Calculator

When evaluating a clinical trial, readers often jump to the P value of the primary endpoint to determine whether the results of a trial are “statistically significant” or not. Although the P value is truly a continuous variable, the scientific community has been conditioned to disregard all results with P values ≥ 0.05, but to fully endorse any trials with a “statistically significant” P value less than 0.05.

Putting the debate and controversy about P values aside for the moment, as a reader, would you be less impressed with a study that changed from being statistically significant to insignificant if one single patient changed from not having the primary endpoint to having the primary endpoint? Especially in an era with a blind reliance on P values, the knowledge of the “fragility” or “robustness” of a study’s P value is another useful data point for readers to critically understand and analyze the results of a clinical trial.

The Concept of the “Fragility Index” for Clinical Trials

Continue reading