Author: Alexandra Argyraki, Excelya PV & Safety Department
Introduction
Early phase clinical trials have their own unique challenges, as they play a vital role in drug development. During early trials we aim to evaluate the safety, tolerability, and pharmacokinetics of investigational compounds in human subjects. These trials often involve small participant populations, novel therapies, and limited exposure data. Consequently, identifying and managing potential risks become paramount in ensuring the safety and well-being of trial participants.
This whitepaper delves into the multifaceted challenges faced by sponsors, investigators, and regulatory bodies in pharmacovigilance during early phase clinical trials. We aim to provide a comprehensive overview of the key areas that demand
heightened attention and proactive measures in the context of safety monitoring and adverse event reporting.
Authorities such as the World Health organisation have guidelines and tools to help us achieve this, and regulatory boards help us keep in check with providing optimal patient care.
We hope to help you navigate this process, and provide some background knowledge of how you can best find solutions to these unique challenges.
