Drugs

FDA Meeting on AI pilot for Early-Stage Clinical Trials

FDA will convene a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the use of artificial intelligence in early-stage clinical trials. The 5/15 virtual session will focus on an agency request for information seeking stakeholder input on how AI-enabled technologies could improve the efficiency, speed and quality of decision-making in Phase 1 studies.

According to the agency, the proposed pilot will examine how advances in AI and data science might enhance safety monitoring, support dose selection and enable more informed early “go/no-go” decisions — such as whether a first-in-human trial should proceed — while maintaining the FDA’s scientific and regulatory standards.

The initiative is part of a broader FDA push to modernize clinical trial oversight, including efforts to incorporate real-time data and digital tools into regulatory review. Officials have emphasized that any AI applications would need to meet expectations for reliability and “trustworthy” system design.

The agency said it will accept electronic or written comments on the proposal through May 29. Registration for the virtual meeting is available via an FDA Webinar page, with additional details outlined in an accompanying FDA announcement.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome