Article | January 18, 2012

ePRO For Late Phase, Post-Approval Market

Source: PHT Corporation

Over the last few years regulators have begun asking clinical trial sponsors for additional research to evaluate the real-world safety and effectiveness of their drugs, often requesting Late Phase trials or post-approval studies as a condition for continued market approval. Regulators have discovered that while data gleaned from controlled conditions within clinical trials may be enough to satisfy efficacy requirements for approval, detecting a drug's safety in the natural world is often more difficult. One reason is that clinical trial populations tend to be too small to tatistically detect safety signals.

  • Global government regulators, insurers and sponsors are seeking more evidence–based research and PRO data in real-world settings.
  • Sponsors anticipating data submission of Late Phase and post-approval studies are requesting ePRO collection.
  • Internet and smartphone adoption are increasing, so that more patients have the tools to collect ePRO data.