What Actually Gets Digital Endpoints Approved

‼️Why do scientifically sound digitally-derived endpoints in drug trials still fail?

Regulatory acceptance of digitally-derived endpoints is rigorous—for good reason. It often takes multiple prospective studies to prove not just technical performance, but clinical relevance.

But from working closely with large pharma teams trying to operationalize these endpoints, one truth keeps surfacing:

👉 The strategy doesn’t collapse at the point of validation—it breaks at the point of coordination.

Digital endpoints still live in a fragmented reality—where:

⛓️‍💥 Medical, clinical ops, regulatory, and digital teams speak entirely different operational languages

🚨 Validation is often technical first, clinically meaningful second

📆 Health Authority (HA) engagement is often reactive, not programmatic

❌ The burden of proving "value beyond standard endpoints" is siloed—or worse, assumed

👇 So, here I share some lessons I’ve learned from my practice: how strategy, coordination, and regulatory alignment must evolve together to truly get digital endpoints from pilot to pivotal. I hope this is helpful :)

Guide to Regulatory Strategy