Регуляторные исследования и экспертиза лекарственных средств (Jul 2024)
Programme for Studying Medicinal Products for Generalised Anxiety Disorder: Analysis of the European Medicines Agency Guideline
Abstract
INTRODUCTION. Generalised anxiety disorder (GAD) is the least studied anxiety disorder, as patients present with comorbid mood disorders. Finding effective treatment methods for GAD is of the utmost importance; therefore, it is essential to develop novel medicinal products for GAD. Proper clinical programme design is key to obtaining reliable data on the effectiveness and safety of a medicinal product. Currently, the Russian Federation lacks methodological guidelines for clinical studies of these medcinal products, and there is a need for developing such guidelines.AIM. This review aimed to assess the possibility of applying the methodological approaches described in international guidelines to Russian clinical trials to develop medicinal products for GAD.DISCUSSION. Having analysed the main provisions of the Guideline on the clinical investigation of medicinal products indicated for generalised anxiety disorder by the European Medicines Agency (EMA), the authors of this review outlined the main stages of clinical development and the methodology for using clinical data to evaluate the safety and efficacy of medicinal products for GAD. Clinical development programmes for these medicinal products should take into account research staging and mandatory long-term safety and additive effect assessments. This review highlights aspects of selecting the design, population, and primary and secondary endpoints for a clinical trial. Particular attention is paid to the consideration of comorbidities in patients.CONCLUSION. The provisions set forth in the EMA guideline can inform the development of national guidelines for studying medicinal products for GAD.
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