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US FDA Pushing Coronavirus Trial Sponsors To Include Control Groups

 
• By Derrick Gingery

“We still try hard to get people to have a control group,” Bob Temple says in an interview. “Not everybody always wants to have a control group. We've been trying hard to do it.”

International regulators are concerned about the growing number of underpowered clinical trials competing for essential resources. • Source: Shutterstock

Amid the rush of coronavirus therapeutic proposals and a drive to gather data quickly, US Food and Drug Administration officials said they continue to push for development program characteristics to ensure the information is as useful as possible.

In an interview with the Pink Sheet, Robert Temple, deputy director for clinical science in the FDA’s Center for Drug Evaluation and Research, said that effort includes

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