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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...

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The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.

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New UK Network Targets Speed And Inclusion For Commercial Clinical Trials

 
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Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
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Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.