AI in clinical trials: Current status, challenges, and future directions for emergency infectious disease clinical trials -Insights from the 2025 iCROWN Symposium.

Abstract

Artificial intelligence (AI) has the potential to transform how drug development and clinical trials are conducted. The 2025 Infectious Disease Clinical Research Network with National Repository (iCROWN) Symposium held in Japan on January 26, 2026 brought together experts from academia, industry, and research ethics to discuss current applications, limitations, and ethical considerations of AI in clinical trials, with a particular focus on emergency infectious disease research. Presentations highlighted a wide range of use cases for generative AI, including protocol writing; generating and reviewing clinical trial documents such as the statistical analysis plan (SAP) and the clinical study report (CSR); patient matching; data monitoring; and query creation. These applications are expected to accelerate and streamline clinical trials while maintaining quality and reducing costs. Standardization of digital data flows in clinical trials further facilitates the adoption of AI. Drawing on the FDA-EMA guiding principles for good AI practice, discussions emphasized the importance of accountability, explainability, fairness, and generalizability, while addressing risks such as overreliance, bias, and deskilling. The symposium concluded that while AI may enable more efficient clinical trial deployment during future public health crises, its challenges must be recognized and addressed.