Defining and Categorising Human-AI Interactions in Clinical Trials: A Multidimensional Human-AI Classification Approach

This paper examines human-AI interactions (HAIIs) in clinical trials and presents a multidimensional categorisation framework that classifies interactions according to AI tasks, human-AI relationships, interaction configurations and interacting human groups. We define HAII, examine existing taxonomies and extend existing categorisation approaches through this novel multidimensional framework. We purposively sampled 15 clinical trials from a previously reported dataset. Each trial was independently categorised by two human reviewers and six large language model (LLM) classifiers. The proposed categorisation provides a structured method for the consistent identification, comparison and synthesis of human-AI interactions across clinical-trial records. The framework is intended to support more consistent comparison and synthesis of AI-related clinical trials and to make explicit the different forms of human involvement associated with AI interventions. The results demonstrate the potential for LLM-assisted categorisation while indicating the continuing importance of human judgement where trial records are incomplete or ambiguous. The principal contribution is a proposed multidimensional framework that brings together AI tasks, human-AI relationships, interaction configurations and interacting human groups within a single approach designed for clinical-trial records. Its significance lies in its potential to support more systematic identification, comparison and synthesis of how humans and AI interact in clinical trials.