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ICH Guide On Selective Reporting Of Safety Data Faces Major Rewrite

 
• By Vibha Sharma

The International Council for Harmonisation is making big changes to its E19 guideline that proposes taking a targeted approach to safety data collection in some late-stage clinical trials. The draft guideline, which is largely similar to the US guideline on this topic, drew varied comments from stakeholders, including those from the EU. 

Render illustration of Clinical Trial title on medical documents
Unnecessary collection of safety data can be burdensome for trial participants • Source: Shutterstock

The International Council for Harmonisation is making significant changes to its draft E19 guideline, which proposes limiting the collection of safety data in some late-stage pre or postmarketing studies when the safety profile of a drug is sufficiently characterized.

The guideline is being “re-written considerably” to address the “extensive comments” it drew from stakeholders, including notably some EU competent...

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