Pharmacovigilance Safety Monitoring in Clinical Trials

Abstract

Pharmacovigilance is that the science and activities associated with the gathering, detection and assessment of adverse event data. Major purpose of pharmacovigilance is to gauge the benefit- risk profile of drug for better efficacy and safety to be used in patients. Pharmacovigilance plays a major role in rationale use of drug which provides the information about the adverse drug reactions which seen in patients. In terms of volume Indian Pharma industry is third largest in world and in terms of value id thirteen largest in world. India is also known as a hub for clinical research and drug development. There is a requirement of a global and standardized pharmacovigilance system in India for better safety assessment in India. In drug development process the only priority of clinical trials is to make sure patient safety during and after the trials. A critical component throughout the drug development life-cycle is monitoring patient safety. Patient must be treated consistent with the requirements and illness of patient therefore the utmost value is given to monitoring of patient safety in the least levels of drug development. Such monitoring may be a dynamic process so to approach safety monitoring. To ensure a systematic approach to safety monitoring pharmaceutical sponsor must work proactively and collaboratively with all stakeholders. We have to focus upon all the aspects of drug safety in clinical trials including basics of drug safety, regulatory aspects of drug safety, patient suitability for safety in trials, post marketing safety and causality risk assessment of the drug products.

Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges—A Narrative Review

“…It encompasses the ongoing monitoring of the benefit:risk relationship of investigational pharmaceuticals administered during the trial [ 46 , 174 ]. Sponsors and investigators have a responsibility to promptly report any adverse events or changes in this relationship to relevant authorities and ethics committees [ 175 , 176 ]. Compliance with regulatory standards, such as ICH GCP and USFDA guidelines, is essential to provide a robust evidence base for medication approvals while prioritizing patient safety [ 177 ].…”