What The FDA And EMA Discussion Papers Reveal About AI In Clinical Research

The integration of artificial intelligence (AI) into clinical processes, when coupled with effective human oversight, has the potential to significantly enhance efficiency. One notable impact is the acceleration of study development as AI-assisted solutions streamline and expedite repetitive and time-consuming tasks for research teams. Despite these advancements, a critical challenge lies in the absence of standardized practices for AI, hindering the ability to mitigate both real and perceived risks and ensure the safety, compliance, and predictability of AI applications.

The ongoing discourse surrounding the standardization of AI for secure implementation in clinical research has gained momentum. Recent discussion papers on AI in drug development released by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mark regulatory bodies' active participation in shaping this dialogue. Importantly, these publications serve as catalysts for discussions within the research community, emphasizing the need to optimize AI use in drug development while safeguarding patient well-being.

Learn how having a comprehensive understanding of regulatory perspectives on AI ethics will prove invaluable for researchers evaluating the integration of AI technology into their trials by accessing the article below.