PHARMACOVIGILANCE IN CLINICAL TRIALS

Vani Varia*, Jiya Goswami, Yagnesh D. Modi, Rashmi Rajgorpade, Dr. D. B. Mishram

When new therapeutic interventions are developed, clinical trials become an essential part of the drug development process to establish efficacy and safety. However, these trials also expose patient to unknown risks and adverse reaction which can addressed with help of pharmacovigilance. The World Health Organization defines pharmacovigilance as the science of detecting, assessing, understanding, and preventing adverse drug reactions or other drug-related problems. It plays a critical role in ensuring patient safety during clinical trials. Effective pharmacovigilance involves systematic monitoring and reporting of adverse events, maintaining data integrity, and continuously evaluating the benefit–risk balance of investigational products. By integrating ethical principles, Good Clinical Practice (GCP) guidelines, and modern technologies such as electronic data capture, artificial intelligence, and real-world evidence, pharmacovigilance enhances the reliability of clinical research and safeguards patient welfare. This review article highlights the processes, challenges, and future directions of pharmacovigilance in clinical trials, emphasizing its importance in the development of safe and effective medicines.