Jul 09, 2025
The FDA final guidance on "Conducting Clinical Trials with Decentralized Elements" marks a turning point in the domain of clinical trials. This blog post explores how DCTs utilize technology and local healthcare to ensure greater access and diversity for the patient population, decrease burden, and offer real-world evidence. It discusses the risk-based approach embraced by the FDA, bearing in mind patient safety and data integrity, and gives recommendations on trial design, data management, and the roles of multiple stakeholders. This guidance signifies an entry point to an accessible, efficient, and patient-friendly future in clinical investigations.
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