Challenges and Opportunities of AI in Trial Design

Abstract

Artificial intelligence is poised to revolutionize clinical trial design, offering unprecedented opportunities to optimize various aspects of the trial process. AI-driven tools can enhance patient recruitment, improve predictive accuracy, and strengthen data analysis capabilities, leading to more efficient and patient-centric trials. However, the integration of AI also presents significant challenges, including ethical considerations, data privacy risks, and regulatory compliance hurdles. This paper examines both the transformative potential and the inherent obstacles of applying AI in clinical trial design. Through an analysis of real-world applications, case studies, and future directions, we explore how AI can facilitate more adaptive, efficient, and patient-focused trials. Simultaneously, we emphasize the critical need for robust ethical frameworks and rigorous regulatory to mitigate the risks associated with AI adoption in this sensitive domain