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In Clinical pharmacology and therapeutics

Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory agencies. The discovery of serious ADRs leading to substantial morbidity and mortality has resulted in mandatory Phase IV clinical trials, black box warnings, and withdrawal of drugs from the market. Real World Data, data collected during routine clinical care, is being adopted by innovators, regulators, payors, and providers to inform decision making throughout the product life cycle. We outline several different approaches to modern pharmacovigilance, including spontaneous reporting databases, electronic health record monitoring and research frameworks, social media surveillance, and the use of digital devices. Some of these platforms are well established while others are still emerging, or experimental. We highlight both the potential opportunity, as well as the existing challenges within these pharmacovigilance systems that have already begun to impact the drug development process, as well as the landscape of postmarket drug safety monitoring. Further research and investment into different and complementary pharmacovigilance systems is needed to ensure the continued safety of pharmacotherapy.

Lavertu Adam, Vora Bianca, Giacomini Kathleen M, Altman Russ, Rensi Stefano


Adverse Event Reporting, Artificial Intelligence, Pharmacoepidemiology, Pharmacovigilance