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FDA Takes Additional Steps to Advance Decentralized Clinical Trials

Updated: Jun 9, 2023

Today, the agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research. Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant’s home using telemedicine.


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