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Health Canada Looks At Easing Burden Involved With Running Expanded Access Trials

 
• By Vibha Sharma

As part of efforts to modernize its clinical trials framework, the Canadian regulator is looking to better facilitate expanded access clinical trials, which allow investigational drugs to reach patients with serious conditions before they are approved.

Close-up of a red map pin on the modern road leading to modern big city. 3D Illustration
Decentralized models can expand the geographic outreach of expanded access trials (Shutterstock)
Key Takeaways
  • Health Canada is analyzing feedback from stakeholders to decide how it can better support expanded access clinical trials, which is a mechanism for patients with unmet medical needs to access unauthorized products.
  • Expanded access trials can also help generate long-term safety or tolerability data and real-world evidence that companies can use to supplement results from confirmatory clinical trials in a regulatory submission.
  • The regulator will use stakeholder feedback to develop the next steps for enabling expanded access and related timelines for final guidance on this topic.
  • Some of the suggestions will also help Health Canada modernize its wider regulatory framework for all clinical trials and facilitate more decentralized, delegated models.

Health Canada is working to develop a more streamlined and transparent process to help sponsors set up and conduct expanded access clinical trials.

It is doing so following feedback from stakeholders on how to better enable these trials, which allow patients with serious or life-threatening conditions to access investigational drugs outside of traditional...

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