The results of the analysis of materials on the safety of clinical trials

• Main Author: Yu. V. Olefir
• Format: Article
• Language: Russian
• Published: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation 2018-02-01
• Series: Безопасность и риск фармакотерапии
• Subjects: анализ; обобщение; безопасность; клиническое исследование; лекарственное средство; разрабатываемый препарат; серьезное нежелательное явление; серьезная нежелательная реакция; отчет по безопасности разрабатываемого лекарственного препарата; analysis; synthesis; drug; safety; clinical trials; medicines; serious adverse event; serious adverse reaction
• Online Access: https://www.risksafety.ru/jour/article/view/62

The article presents the results of the Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of Russia of the analysis and generalization of materials on the safety of clinical trials of medicines for medical use (including international multi-center clinical trials), permits for which were issued by the Ministry of Health of Russia. Study materials consist of 38273 submissions of developers of medicines, containing information about 62462 the occurrence of serious adverse events and serious adverse reactions to new drugs, and safety update reports from 1 July 2012 to 31 December 2016. The results of the analysis and generalization of obtained with the use of modern methods of investigation allowed the authors to establish the existence of quantitative and qualitative problems with material of safety clinical studies in 2012-2013. It is shown that already in 2013 the complex was developed and implemented measures helped to solve the identified problems: to increase by 22 times the number of clinical trial materials received from the Russian clinical centers and eliminate problems with the quality of the submissions, which is currently equally acceptable for all developers and organizations conducting clinical research. Recommendations for effective analysis and synthesis of the material safety clinical studies of medicinal products by the regulatory authorities, allowing to quickly make evidence-based decisions in relation to the preparation of recommendations for adoption of administrative decisions in the field of pharmacovigilance and clinical research.