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This article is devoted to an ethical review of planned real-world studies. The legal basis of such examinations has also been considered. Most real-world studies are non-interventional, so the ethical review of such studies is similar to that of observational studies.

The article describes post-authorization clinical trials of medicinal products for medical use conducted by pharmaceutical manufacturers after state registration, in order to collect additional data on safety and efficacy, expand indications for use, and identify adverse reactions.