Novel “SMARTer” Clinical Trial Design Improves Odds of Approval and Can Reduce Study Size By Over 80%: Modeling Use of a ctDNA “Optimizing Diagnostic” for …

FE Taub, D Gao - medRxiv, 2023 - medrxiv.org
Novel pivotal trial designs, that more clearly demonstrate increased benefit over Standard of
Care (SOC), especially in oncology and immuno-oncology (IO) are presented. The benefit of …

[PDF][PDF] Novel “SMARTer” Clinical Trial Design Improves Odds of Approval and Can Reduce Study Size By 80%: Modeling Use of a ctDNA “Optimizing Diagnostic” for …

FE Taub, D Gao - 2023 - medrxiv.org
Novel pivotal trial designs, that more clearly demonstrate increased benefit over Standard of
Care (SOC), especially in oncology and immuno-oncology (IO), are presented. The benefit …