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.
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...
