The increasing use of AI algorithms in clinical trials has raised concerns about validation, reliability, and transparency (Greenleaf Health). Regulatory bodies such as the FDA are expected to address these issues as AI becomes integral to drug development and regulatory submissions. The question will be suspended on 29 September 2025 and the outcome determined based on official documentation or announcements from the FDA available as of approximately 5:00p.m. ET on 30 September 2025. A formal guidance is defined as a published document explicitly addressing validation requirements for AI algorithms in the context of clinical trials appearing on the US Federal Register website (Federal Register - FDA). Any document (e.g., interim rules) will count, including a document available on the Federal Register website that has a "publish" date after 30 September 2025.

Confused? Check our FAQ or ask us for help. To learn more about Good Judgment and Superforecasting, click here.

To learn more about how you can become a Superforecaster, see here. For other posts from our Insights blog, click here.