Clinical development is still shaped by a stubborn asymmetry: only around one in ten drug candidates that enter human testing ever reaches approval, and Phase II/III failures remain the biggest drivers of wasted R&D spend.
Despite growing use of de-risking strategies such as genetics-anchored target selection, increasing use of biomarker-stratified and enrichment designs, and innovative designs such as adaptive enrichment and master protocols, late-stage failure rates are still high with only a small minority of Phase I assets ultimately reaching approval.
Against that…
