Comment from Domino Data Lab
AnonymousSupportBusiness
Summary: Domino Data Lab, a technology company, supports the FDA's pilot program for AI in early-phase clinical trials. They argue that the pilot should focus on high-consequence use cases like safety monitoring and dose selection, emphasizing the need for human oversight, reproducibility, and clear metrics for decision quality.
Domino Data Lab is pleased to submit the attached response to FDA’s Request for Information on the use of AI in early-phase clinical trials. Our perspective is informed by work with biopharmaceutical organizations across clinical development, statistical computing, data science, and regulated AI adoption.
A consistent theme throughout our response is that the most promising applications of AI are those that support high-consequence decisions made under uncertainty, including safety assessment, dose selection, patient stratification, and progression through clinical development. We believe the pilot presents an opportunity to generate practical evidence on where AI can improve decision quality and operational consistency, while also establishing expectations for reproducibility, traceability, transparency, and human oversight in regulated environments.