Global Journal of Critical Care and Emergency Medicine
Open AccessBeyond the LVEF: Modernizing Pharmacovigilance and Cardiovascular Risk Management in Early-Phase Clinical Trials
Authors: Mario Alejandro Castellanos U.
Abstract
Background: Traditional pharmacovigilance (PV) has historically relied on reactive functional changes, such as a
decrease in Left Ventricular Ejection Fraction (LVEF). However, the emergence of targeted therapies demands a shift
toward proactive, molecular-level surveillance [1].
Objective: This article explores modern strategies for cardiac signal detection in early- phase trials, emphasizing the
integration of high-sensitivity biomarkers and advanced imaging [2].
Conclusion: Modernizing PV through "Precision MPharmacovigilance (PV), Drug safety surveillance, Adverse drug reactions (ADR), Signal detection, Risk management.onitoring" enhances participant safety and prevents premature
attrition of drug candidates [3].
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