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Observational Study Hurdles: From Data Blinding To Data Sharing

 
• By Brenda Sandburg

US FDA’s Robert Temple says the agency is very worried about ensuring investigators are blinded to the results of observational studies and is currently writing a guidance document to address this.

hurdle
Observational studies face hurdles in gaining acceptance by scientific community • Source: Shutterstock

The US Food and Drug Administration is evaluating the potential of observational studies to provide evidence of a drug product’s effectiveness. But there are concerns about the design and conduct of these studies and whether regulators can rely on them in making decisions about a product.

At a recent meeting on the topic, stakeholders noted that a key issue is ensuring investigators are blinded to the results of observational studies as they are in clinical trials....

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