The FDA’s 2024 guidance on decentralized clinical trials (DCTs) has the potential to transform clinical research, particularly in oncology. While many still view DCTs as either fully virtual or fully in-person, the guidance promotes a hybrid approach, blending traditional and decentralized elements. This flexibility may help smaller sites participate alongside large academic medical centers, making trials more accessible to rural and underserved areas.

However, challenges remain, including regulatory complexities, patient safety concerns, and infrastructure demands—especially for oncology studies, which are inherently intricate and costly. The FDA’s choice to issue nonbinding guidance rather than enforceable regulations reflects a desire for progress without lengthy regulatory delays, even as it leaves questions about enforcement and compliance.

The guidance hints at using healthcare providers innovatively, potentially improving recruitment and trial access. Still, the reliance on guidance rather than regulations raises concerns about consistency, as auditors often treat nonbinding recommendations as de facto rules.

Ultimately, while the DCT model offers promise, particularly for oncology, its success hinges on balancing flexibility with clear standards, empowering both large and small research sites to deliver innovative treatments effectively.

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