09/16/2025
🚨 The Clinical Trial Crisis Nobody's Talking About
67% of clinical trials happen in just two regions: North America and Europe.
Meanwhile, regulatory bodies worldwide are demanding proof that therapies work for THEIR populations:
🇺🇸 FDA: "Include diverse populations"
🇧🇷 ANVISA: "Consider Brazilian demographics"
🇲🇽 COFEPRIS: "Show Mexican population data"
🇮🇳 CDSCO: "Prove efficacy across Indian subgroups"
The result? Billions of patients—rural communities, indigenous populations, aging demographics—systematically excluded by design.
This isn't a diversity problem. It's a regulatory translation crisis.
In oncology alone, only 1% of trial participants are Hispanic/Latino. Rural populations face massive barriers despite representing 20% of Americans.
While most companies digitize the maze, we're deleting it.
✅ Our Trial Activation Intelligence designs protocols for global populations from day one
✅ Anticipates regulatory requirements across jurisdictions
✅ Turns compliance into competitive advantage
Early adopters report 40% faster enrollment and 60% fewer amendments.
Because breakthroughs should reach everyone, not just the convenient populations.
👉 Read the full analysis: https://open.substack.com/pub/steventhompsonai/p/the-protocol-population-disconnect?r=5jp655&utm_campaign=post&utm_medium=web&showWelcomeOnShare=true
The global trial crisis: protocols built for convenience, not the populations they’re meant to treat.
