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UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

Doctor using laptop and electronic medical record (EMR) system. Digital database of patient's health care and personal information on computer screen. Hand on mouse and typing with keyboard.
Use of external control arms suits situations where RCTs are challenging (Shutterstock)
Key Takeaways
  • The UK’s newly published draft guideline on the use of external control arms based on real-world data (RWD) closely aligns with the 2023 US guidance on this topic.

The UK Medicines and Healthcare products Regulatory Agency’s latest draft guideline on using external control...

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