Real-world clinical practice for planning clinical trials of psychopharmacotherapy efficacy

This article examines the value of real-world clinical practice (RCP) research in expanding the evidence-based medicine paradigm in psychiatry.Although randomized clinical trials (RCTs) are considered the "gold standard", they have limitations and are not always feasible in certain clinical scenarios, including pregnancy, pediatric and geriatric populations, comorbidity, and treatment-resistant conditions. RCP research — which incorporates registry data and observational studies — enables the identification of prescribing patterns in psychopharmacotherapy, the assessment of long-term efficacy and safety, and provides a foundation for more targeted and pragmatic RCT design. The value of RCP research is illustrated with concrete examples. The article also discusses the potential of the Federal Register of Patients with Mental Disorders (FRPMD), currently being developed in Russia, as a data source for future studies.