Insight Brief
From Framework to Field
Strategic navigation of decentralized patient-centric trials
Jun 09, 2025
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The 2024 FDA guidance, Conducting Clinical Trials with Decentralized Elements, marks a decisive step forward in planning and operationalizing patient-centric trials. It clarifies their May 2023 draft on decentralized clinical trials (DCT) and supports DCTs for drug/device development. However, decentralized trials necessitate integrated technology solutions, which are not consistently available across the numerous organizations conducting DCTs. Trial sponsors should carefully consider where services will be received, and the data sources involved. While ambiguities may vary by role, certain issues still lack clear direction. The final guidance offers a useful foundation by elaborating on two critical areas:

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