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FDA’s Califf Calls For Return To Large, Simple Trials Without The ‘Useless Stuff’ That Slows Development

 
• By Kate Rawson

US FDA Commissioner Califf praises both Project Pragmatica and the ‘very powerful’ partnership between OCE Director Rick Pazdur and National Cancer Institute Director Monica Bertagnolli.

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• Source: Shutterstock

Industry should return to large, simple clinical trial designs that rely on randomization and endpoints that matter most to patients – and remove the excessive data collection that often leads to problems with recruitment, retention and trial cost, Food and Drug Administration Commissioner Robert Califf said.

“Randomization as a tool is an amazingly elegant tool” to answer important clinical questions, Califf said at the Prevision Policy/Friends of Cancer Research Biopharma Congress last month. “It’s astounding. And...

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