Pandemic Accelerates US FDA’s Use Of Real-World Data From Clinical Trial Design To Supply Chain
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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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.
A randomized COVID-19 study spanning the whole of the UK could help to bolster the UK’s reputation as a location for future clinical trials. It is also being seen partly as the result of the UK regulator's "decisive action" in fast-tracking trials for potential COVID-19 therapies.
Deal Snapshot: Six companies seek to collect convalescent plasma from COVID-19 survivors to quickly develop hyperimmune immunoglobulin therapy for serious complications of the virus.