Is it a predictive or prognostic biomarker?
During my PhD, I got berated for presenting a microRNA algorithm as predictive when I didn't have the full evidence to prove it. I'll never make that mistake again! Sometimes though, I find there are complicated situations when the biomarker can be both, and the FDA BEST (Biomarkers, EndpointS, and other Tools) Resource is a great tool for explaining it.
For example, look at this biomarker survival analysis.
👉 The difference between the solid lines (the experimental treatment) is larger than the difference between the dashed lines (standard of care). Suggesting the biomarker has a survival effect on either drug, but the effect is larger for the experimental drug.
👉 When treated with the experimental drug, patients that are biomarker positive do MUCH BETTER than those that are negative. Whereas, when treated with standard of care, biomarker positive patients DO WORSE than biomarker negative patients.
⭐ BUT, whatever your biomarker status, patients do better with the experimental drug, so this drug doesn't need the biomarker... (when this information alone is considered)
