Updated: Jun 6
The distinction between the categorization of DHT-derived measures as COAs or as biomarkers can be very fine, with terminology variability among regulatory authorities. This has significant implications for integration of DHT-derived measures in clinical trials, leading to confusion regarding the evidence required to support these tools' use in drug development. There is a need to amend definitions and create clear evidentiary requirements to support broad adoption of these new and innovative tools. The biopharma industry, the technology sector, consulting businesses, academic researchers, and regulators need a dialogue via multi-stakeholder collaborations to clarify questions around DHT-derived measures, to unify definitions, and to create the foundations for evidentiary package requirements, providing a path forward to predictable results.