Problems of using artificial intelligence technologies in clinical drug research

The use of artificial intelligence (AI) technologies in clinical trials (CT) of medicines has led to a significant reduction in time and financial costs for the development of new medicines. However, their widespread adoption faces a number of unresolved issues related to data quality, regulation, ethics, and security. The purpose of this study was to assess the current state of AI application in CT and identify key issues hindering its widespread adoption. Results and discussion . The key applications of AI in CT are analyzed: the use of large language models (TrialGPT, Elsa) for data analysis, the creation of digital patient counterparts and synthetic controls for CT modeling, as well as predictive analytics to optimize research design and risk assessment. It has been shown that these methods can improve the efficiency of patient selection, predict outcomes with a high area under ROC score (up to 92.7 %), and accelerate drug development. However, serious limitations have been identified: the dependence of the quality of models on the representativeness of data, the risks associated with imperfect algorithms, as well as the lack of specialized regulatory regulation and standards, including in the Russian Federation. The problems of data confidentiality, obtaining informed consent, and determining responsibility for harm caused by the use of AI are highlighted. Conclusions. The widespread use of AI to increase the efficiency and personalization of CT, its scaling requires solving complex regulatory, legal and ethical challenges.