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New Global GCP Standard Puts Proportionality In Focus For Trial Sponsors

 
• By Vibha Sharma

Pharma industry representative at the ICH expert working group that drew-up the new international good clinical practice standard is advising trial sponsors to focus on proportionality and a risk-based approach throughout their trial design, conduct, analysis and reporting.

Stack of zen stones in balance at seashore
All aspects of a clinical trial should match the risks to participants and results (Shutterstock)
Key Takeaways
  • Trial sponsors are being urged to review and update their standard operating procedures to comply with the new ICH E6(R3) guideline, which emphasizes a risk-based, proportionate approach to clinical trials.

Clinical trial sponsors are being urged to review their standard operating procedures (SOPs) to ensure compliance with the International Council...

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