THE ROLE OF INTERVENTIONAL CLINICAL TRIALS IN THE ASSESSMENT OF MEDICINAL PRODUCT SAFETY: A STRUCTURED REVIEW FOR PHARMACOVIGILANCE TRAINING PROGRAMS
DOI:
https://doi.org/10.32782/eddiscourses/2026-2-6Keywords:
medicinal products, medicinal product safety, clinical studies, interventional clinical trials, pre-authorization studies, post-authorization studies, pharmacovigilance, training program.Abstract
The assessment of medicinal product safety is based on a multilayered system of data accumulated from the preclinical stage through post-authorization pharmacovigilance. Interventional clinical trials play a central role in this process, as they provide standardized and methodologically controlled collection of information on adverse events. At the pre-authorization stage, they enable verification of risks identified in preclinical models and the formation of an initial safety profile, which serves as the basis for the package leaflet and the summary of product characteristics. Post-authorization interventional studies complement these data by refining the long-term safety profile in broader and more heterogeneous populations and by enabling the detection of rare or delayed adverse reactions. They may also address specific regulatory and scientific objectives. Current trends in the development of interventional clinical trials demonstrate the growing role of pragmatic approaches, the integration of real-world elements, and the use of electronic medical records and registries, which enhance the external validity of results without compromising scientific rigor. Understanding the principles of planning, conducting, and interpreting interventional clinical trials is essential for pharmacovigilance professionals, as these studies form the foundation of the evidence base for medicinal product safety throughout the entire product life cycle. This article provides a structured overview of the role of interventional clinical trials in the assessment of medicinal product safety, which may serve as a basis for developing pharmacovigilance training programs.
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