Oncology clinical trials play a pivotal role in the development of new therapeutic options; however, their implementation remains an extremely costly and time-consuming process. Artificial intelligence can open new horizons in the design and conduct of clinical trials, particularly in early phases, where safety, dose planning, and patient recruitment efficiency are critical. This paper aims to explore the potential applications of artificial intelligence in various stages of early-phase oncology trials, including biostatistical design, patient enrollment, and quality assurance aspects. Based on case studies and examples from the literature, it can be concluded that artificial intelligence can assist with precise protocol design, shorten recruitment timelines, and improve predictive performance in dose planning and patient selection, thereby reducing the number of adverse events. At the same time, regulatory, ethical, and data protection challenges remain significant barriers to the widespread adoption of artificial intelligence. Integrating artificial intelligence into clinical trials requires not only technological but also strategic-level modernization, from the industrial companies and authorities as well. The reliable and validated application of artificial intelligence could represent a major advancement in clinical research, particularly in increasing the success rate of early-phase trials. Orv Hetil. 2025; 166(47): 1857-1868.
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