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

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.

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

1. Lepakhin VK, Romanov BK, Toropova IA. The analysis of reports on adverse drug reactions. The Bulletin of the Scientific center for expert evaluation of medical products. 2012; 1: 22–25 (in Russian).

2. Lepakhin VK, Romanov BK, Nikitina TN, Snegireva II. Expert evaluation of risk- benefit analusis of drugs. The Bulletin of the Scientific center for expert evaluation of medical products 2012; 2: 19–21 (in Russian).

3. Kutekhova GV, Lepakhin VK, Romanov BK. Detection of violation in prescribing medicines (OFF-label prescriptions) in pediatric patients. The Bulletin of the Scientific center for expert evaluation of medical products 2012; 3: 23–27 (in Russian).

4. Merkulov VA, Bunyatyan ND, Sakaeva IV, Lepakhin VK, Romanov BK. New legislative initiatives to improve drug safety in the European Union. The Bulletin of the Scientific center for expert evaluation of medical products 2013; 3: 45–48 (in Russian).

5. Alyautdin RN, Romanov BK, Guseynov MD, Lopatin PV, Zilfikarov IN. Experimental screening evaluation of the stress-protection action of herbal remedies. Russian medical journal 2008; 3: 29–33 (in Russian).

6. Vaskova LB, Lopatin PV, Romanov BK. Pharmacoeconomics in pharmacy. Moscow: First Moscowstate medical. University. I. M. Sechenov Of Ministry Of Healthcare Of Russia; 2012 (in Russian).

7. Snegireva II, Zatolochina KE, Ozeretskovsky NA, Romanov BK, Mironov AN. Vaccine pharmacovigilance in Russia, legal and regulatory framework, current stage of development. The Bulletin of the Scientific center for expert evaluation of medical products 2014; 4: 27–31 (in Russian).

8. Zatolochina KE, Snegireva II, Ozeretskovsky NA, Romanov BK, Mironov AN. Features methods of identifying adverse reactions to the vaccination. Doctor-graduate student 2013; 6 (61): 96–103 (in Russian).

9. Merkulov VA, Bunyatyan ND, Sakaeva IV, Lepakhin VK, Romanov BK, Rychikhina EM, Koshechkin KA. The Analysis and generalization of documents on the safety of medicines in the international clinical studies in the Russian Federation. The Bulletin of the Scientific center for expert evaluation of medical products 2013; 2: 21–23 (in Russian).

10. Lepakhin VK, Romanov BK, Snegireva II. Methods of detection and evaluation of adverse reactions to medicines. Guidelines. Moscow: Scientific center for expert evaluation of medical products; 2013 (in Russian).

11. Merkulov VA, Bunyatyan ND, Sakaeva IV, Rychikhina EM, Lepakhin VK, Romanov BK, Komratov AV, Kolesnikova EYu, Koshechkin KA, Kozlovich AV. Improving the system of evaluating drug safety evaluation in clinical trials. The Bulletin of the Scientific center for expert evaluation of medical products 2014; 1: 20–26 (in Russian).