Artificial intelligence-driven innovations in clinical trials: Transforming India’s research landscape

ABSTRACT

India advances its clinical research capabilities through the adoption of artificial intelligence (AI). This development increases the speed and accuracy of clinical trials. It also strengthens data quality and supports better outcomes. This review outlines the current use of AI in Indian clinical trials. It presents key challenges and proposes solutions to improve future progress. A structured literature search covered databases such as PubMed and Scopus along with Google Scholar. This review focused on studies published between 2019 and 2025. AI provides clear advantages for clinical research. These include rapid patient recruitment, faster data validation, and improved safety monitoring. Tools such as automated systems and chatbot technologies reduce delays. They also enhance communication and support smoother trial processes. Several issues continue to affect progress in this area. Many regions lack reliable digital infrastructure. Data collected across trials often lack consistency. India also faces a shortage of professionals with expertise in both clinical research and AI. Ethical concerns continue to grow. These include limited safeguards for informed consent, weak data privacy, and potential bias within AI systems. To address these barriers, India must invest in better digital systems. Training programs should expand to prepare professionals for AI-integrated roles. Clear legal guidelines and ethical frameworks must be developed. Understanding should include members with a strong understanding of AI. With these reforms, India can establish global leadership in safe and effective use of AI in clinical research. This transformation will improve trial quality, enhance patient safety, and strengthen India’s international research reputation.