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ICT Ep 2.36: Robin Piazza on ICH E6 R3 and the New Rules for Safety Oversight (Part 2/2)
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ICT Ep 2.36: Robin Piazza on ICH E6 R3 and the New Rules for Safety Oversight (Part 2/2)
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In Part 2, Robin Piazza, Liam and Ted get specific about what good safety oversight actually looks like in practice, and what sponsors are getting wrong under the shift from FDA 2024 guidance to the stricter ICH E6 R3 standard.
We explore:
- FDA 2024 guidance vs. ICH E6 R3: why global studies need one uniform plan
- Why a DMC charter is a “how the DMC will operate," not evidence, and is what inspectors actually want to see, and whether the charter was followed.
- The hidden conflict when the same experienced DMC member sits on multiple competing trials
What a safety oversight committee looks like when it’s “firing on all cylinders."
Robin also digs into a problem many sponsors don’t see coming: experienced DMC members who sit on multiple competing trials and intelligence bias the conflicts this creates.
This is the practical half of the conversation, moving from why to how, with guidance on getting your safety oversight set up and ready before an inspector asks to see it.