🤖 AI Summary
Inefficient clinical trial data cleaning has become a critical bottleneck in drug development, as traditional manual review struggles to scale with growing data volume and complexity. This paper introduces Octozi, an intelligent review platform integrating large language models (LLMs), domain-specific heuristic rule engines, and AI-assisted decision algorithms to enable human-in-the-loop data curation for high-risk clinical data. Its core innovation lies in tightly coupling general-purpose semantic understanding with clinical knowledge constraints, thereby substantially improving review robustness and interpretability. Experimental results demonstrate that Octozi achieves a 6.03× speedup in data cleaning throughput, reduces error rates from 54.67% to 8.48%, decreases false-positive queries by 15.48×, and maintains consistent performance irrespective of reviewer experience level. The framework establishes a scalable, GCP-compliant paradigm for AI-augmented clinical data governance.
📝 Abstract
Clinical trial data cleaning represents a critical bottleneck in drug development, with manual review processes struggling to manage exponentially increasing data volumes and complexity. This paper presents Octozi, an artificial intelligence-assisted platform that combines large language models with domain-specific heuristics to transform clinical data review. In a controlled experimental study with experienced clinical reviewers (n=10), we demonstrate that AI assistance increased data cleaning throughput by 6.03-fold while simultaneously decreasing cleaning errors from 54.67% to 8.48% (a 6.44-fold improvement). Crucially, the system reduced false positive queries by 15.48-fold, minimizing unnecessary site burden. These improvements were consistent across reviewers regardless of experience level, suggesting broad applicability. Our findings indicate that AI-assisted approaches can address fundamental inefficiencies in clinical trial operations, potentially accelerating drug development timelines and reducing costs while maintaining regulatory compliance. This work establishes a framework for integrating AI into safety-critical clinical workflows and demonstrates the transformative potential of human-AI collaboration in pharmaceutical clinical trials.