Clinical trial digitalization: new opportunities for the use of artificial intelligence

Background. The introduction of artificial intelligence (AI) technologies in clinical trials (CTs) opens up new horizons for drug development, but it is associated with significant methodological and regulatory challenges. The gap between the speed of technological progress and its practical implementation necessitates the development of comprehensive approaches for the effective integration of AI into research practice.

Objective. To summarize and systematize the key areas of AI application at all stages of the clinical trial life cycle, identify existing barriers, and propose a comprehensive model to overcome them.

Materials and methods. A systematic analysis and generalization of data from current scientific publications, regulatory documents, and methodological recommendations on the use of AI in clinical trials was conducted (during 01.09.2019 по 28.08.2025 yy). The concept of a multilevel AI architecture, including perceptual, cognitive, and decision-making intelligence, was used as a basis for structuring the material.

Results. In the course of the analysis, the key areas of AI application were identified and characterized in detail: from the development of a study design and optimization of patient recruitment using digital twins to decentralized data monitoring and predictive analysis of adverse events. The main barriers that hinder the widespread adoption of AI have been identified: data quality and representativeness problems, model insufficient interpretability, lack of unified validation standards, and legal uncertainty. A multilevel model for AI integration is proposed, covering the technological, organizational, ethical, and regulatory aspects.

Conclusion. The full integration of AI into clinical trials can dramatically increase their effectiveness and reduce the time and cost of developing new drugs. We believe that overcoming the existing barriers requires coordinated efforts of the scientific community, regulatory authorities, and the pharmaceutical industry to create a single ecosystem that ensures the transparency, reliability, and ethics of the use of digital technologies.

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