Skip to Main Content
Contribute Try STAT+ Today

Over the past several years, the number of deviations and substantial amendments made to clinical trial protocols has increased notably, contributing to delays in drug development and rising costs for completing studies, a new analysis finds.

From 2018 through March 2020 — before the pandemic disrupted research and development work — the average number of amendments for Phase 1, 2 and 3 trial protocols was 2.4, 2.7 and 3.3, respectively. By comparison, the number of amendments for each of the three trial phases was 1.8, 2.2, and 2.3 from 2013 through 2015, according to the Tufts Center for the Study of Drug Development.

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


What is it?

STAT+ 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.

Create a display name to comment

This name will appear with your comment