Artificial Intelligence in Clinical Trials of Drugs

Artificial intelligence (AI) is revolutionizing the clinical trial paradigm in the pharmaceutical industry at a rapid pace. Machine learning, natural language processing, and real-time analytics enhance every phase of clinical trials—from protocol design and recruitment to monitoring, analysis, and regulatory submission. AI algorithms have been shown to reduce trial length and increase the probability of success. They also enable more personalized and effective strategies for patient engagement. Therefore, this chapter discusses the theoretical frameworks from major international regulatory perspectives and introduces some of the new innovations using AI through all phases (I–IV) of the trials. In addition, the chapter emphasizes the promise and challenges that await AI in clinical development pipelines.