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Clinical Trial Reform Is A Focus For CDER's 2019 Guidance Agenda

 
• By Derrick Gingery

US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.

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The US FDA's drug center plans several clinical development-related guidances in 2019, which may help further its efforts to reform the clinical trial process.

Agency thoughts on novel endpoints and trial designs are part of the calendar year 2019 Center for Drug Evaluation and Research guidance agenda

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