AI/ML in Clinical Trials
The integration of artificial intelligence (AI) and machine learning (ML) into healthcare and clinical research has raised important regulatory considerations. Below are official guidance documents issued by the U.S. Food and Drug Administration (FDA) outlining their approach to AI/ML in medical and clinical settings: 🔹 2018 – FDA Discussion Paper Artificial Intelligence and Machine Learning in Software as a Medical Device This foundational document provides early insights into how the FDA views AI/ML technologies used in medical devices, including expectations around safety, transparency, and continuous learning systems. 👉 Read the paper (PDF) Update (May 2025) 🔹 2025 – FDA Draft Guidance Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products This newly released draft outlines how AI/ML may be used to support regulatory decisions in clinical trials and drug development. It introduces a risk-based framework for as...