Post by ICON plc

Biomarker-based surrogate endpoints can accelerate development timelines – but only when the evidence, pathway and expectations are aligned. In the latest issue of Drug & Device World ICON’s Elizabeth Madichie and Jack Martin examine how accelerated approvals can unlock earlier market access and why weak biomarker foundations, self-competitive confirmatory trials and payer misalignment remain critical risks. As such, a clear-eyed view of both reward and risk is essential for sponsors considering this route. Read the article https://ow.ly/fmae50ZoiCW #ClinicalResearch #DrugDevelopment #RegulatoryStrategy #Biomarkers #AcceleratedApproval