Dr. Robert Califf,  former commissioner of the Food and Drug Administration, said Wednesday the current clinical trial system isn’t working and outlined his vision for a future system based on high-quality evidence and widespread data sharing.

“Beyond early phase intensive mechanistic exploratory trials, I think the clinical trials enterprise has gone awry,” he said, speaking at a conference on clinical trials hosted by the New York Academy of Sciences, “It’s become unnecessarily expensive, cumbersome, arcane, and it’s causing, I think, a search for alternatives partly out of desperation, because the way it’s being done now isn’t answering the questions people are most concerned about.”

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!


What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
Sign up to receive a free weekly opinions recap from our community of experts.
Privacy Policy