MedAssessment presented a thought experiment to the DIA Clinical Safety and Pharmacovigilance Thought Leadership Community on May 20, 2021. If AI could be applied to Safety Case Assessments, what would that look like?

Together with the DIA Community Dr. Peg Fletcher explored a hypothetical Phase 1 study of a new chemical entity with 20 end-stage pancreatic cancer patients treated to date. The PVG task was to determine the cause of the event.

As recently expressed by Dr. Gerald Dal Pan, the Community discussion found great potential for AI for initial case processing, but stopped short of endorsing the use of AI for causality, concluding that a “Human in the Loop” is necessary. Inspired by FDA’s encouragement, MedAssessment is currently investigating use of AI in first line case processing and literature monitoring.

For more information about Dr. Fletcher's presentation to the DIA Clinical Safety and Pharmacovigilance Thought Leadership Community discussion on May 20, 2021, please click below: