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Real-World Data Could Get Boost From Trial Replication Project

 
• By Derrick Gingery

Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.

Yellow road sign with a blue sky and white clouds: clinical trial

A project funded by the US FDA could lay the groundwork for potentially using real-world evidence instead of a clinical trial as part of a drug development strategy.

A group that includes Brigham and Women's Hospital, Harvard Medical School, and health care data company Aetion, is seeking to replicate the results of 30 randomized clinical trials using claims...

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Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
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Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.