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US FDA Offers More Advice On Mid-Trial Changes For Pandemic-Impacted Studies

A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.

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External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization

Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.

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