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Pandemic Accelerates US FDA’s Use Of Real-World Data From Clinical Trial Design To Supply Chain

Executive Summary

FDA’s Amy Abernethy describes how agency’s use of real-world data has evolved in response to COVID-19 and the ‘a-ha’ moment of leveraging different data sources to understand the coronavirus. Takeda R&D President Andrew Plump notes difficulties with platform trials and limitations on data sharing.

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US FDA’s Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

After slightly more than two years as second-in-command, Abernethy says she’s leaving FDA because her initiatives were starting to develop their own momentum. Abernethy, who the agency’s acting chief information officer, worked to modernize FDA’s information technology infrastructure and data capabilities while also exploring confidently using real-world data to support regulatory decision-making.

US FDA’s Amy Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop their own momentum. Abernethy, who also serves as the agency’s acting chief information officer, worked to modernize the FDA’s information technology infrastructure and data capabilities while also exploring ways to confidently use real-world data to support regulatory decision-making.

US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines

Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it can use real-world data and evidence for COVID-19 vaccine evaluation.

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