AI Integration in Clinical Research Faces 'Last-Mile Hurdles' in Real-World Application
Implementing Artificial Intelligence (AI) in real-world clinical research faces significant challenges, particularly concerning Good Clinical Practice (GCP) compliance and data integrity, according to Marc Wartenberger, vice president of compliance and security at CRIO. Speaking at the SCOPE Europe event, Wartenberger highlighted that while personal productivity AI tools are less concerning, those impacting adverse events or drug treatment decisions require rigorous scrutiny. The updated ICH E6(R3) guideline emphasizes risk-based workflows, but integrating AI necessitates additional checks for bias and drift. Accountability for AI-supported decisions cannot be delegated to technology, requiring human oversight and understanding. Data privacy and protection are major concerns, with warnings against plugging sensitive data into public AI tools without adequate safeguards. The validation of AI tools is also more complex than traditional software due to their continuous evolution, posing a challenge for regula...
