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FDA Publishes Final Guidance For Sponsors Of Decentralized Clinical Trials

 
• By Brian Bossetta

The US FDA is providing recommendations for sponsors conducting clinical trials outside traditional settings, such as individual homes, mobile research units, and remotely via telehealth participation. The agency says the guidance is part of an overall effort to advance how trials are designed and run.

DECENTRALIZED
• Source: Shutterstock

The Food and Drug Administration has dropped its final guidance document for sponsors and investigators wishing to implement decentralized clinical trials, which can be run remotely to make participation more convenient.

A decentralized clinical trial (DCT) is one that occurs at locations other than traditional clinical trial sites. As the final...

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