Abstract

A REVIEW ON PHARMACOVIGILANCE IN CLINICAL TRIALS AND DRUG DEVELOPMENT

Shubham Ghosh^*, Moutoshi Singh, Partha Pratim Maiti and Rupak Das

Abstract

Pharmacovigilance and clinical trials operate in tandem, any adverse events reported by trial participants are forwarded to the pharmacovigilance team. Safety in clinical trials is a crucial aspect of pharmacovigilance. Before being put on the market, all medications must successfully finish a clinical trial program that provides sufficient proof of their efficacy and safety. Here, we'll talk about clinical trials and pharmacovigilance and their relationships. Recent developments and trends have brought about revolutionary changes in pharmacovigilance, a discipline that is essential to guaranteeing the safety of pharmaceutical products. Real-world evidence has broadened the scope of medication safety monitoring by offering insights into the larger patient population. This evidence comes from a variety of sources, including electronic health records and pragmatic studies. Signal detection and predictive analytics have been transformed by artificial intelligence and machine learning, which has improved risk management techniques and expedited the discovery of possible safety issues. Patient safety monitoring is an essential part of the medication development life-cycle. At the lowest stages of medication development, the highest importance is placed on patient safety monitoring since patients must be treated according to their needs and conditions. For the purpose of approaching safety monitoring, such monitoring may be a dynamic process. A proactive and cooperative attitude with all stakeholders is required of pharmaceutical sponsors to guarantee a methodical approach to safety monitoring. The fundamentals of medication safety, regulatory aspects of drug safety, patient appropriateness for trial safety, post-marketing safety, and causation risk assessment of the drug products are all areas that require our attention throughout clinical trials.

Keywords: Pharmacovigilance, Clinical trials, Drug safety, Post-marketing safety, Artificial intelligence.