Making Sense of Animal-to-Human Drug Development Evidence: Stakeholder Practices, Challenges, and Requirements for AI Tools

Abstract

Animal models are widely used to study human biology and health interventions, yet translating findings from animal studies to humans remains challenging. Evidence across preclinical and clinical research informs experimental and translational decisions. Artificial Intelligence (AI) tools are increasingly reshaping how this evidence is searched, synthesized, and used, but it remains unclear how they should support the diverse stakeholders involved in assessing animal-to-human evidence. We conducted semi-structured interviews with 13 stakeholders to examine their evidence practices, challenges, and expectations for AI support. We found that stakeholders approach the same incomplete evidence base with different goals, expertise, and heuristics. Participants valued AI particularly for locating, screening, and extracting evidence, but were more cautious about automated interpretation and quality judgments. They emphasized transparency, source traceability, uncertainty communication, and human oversight. Based on these findings, we derive design implications for role-sensitive AI tools that support more systematic and transparent reasoning about animal-to-human translation.