Abstract [eng] |
Long Pharmaceutical Way Achieving the Patient: from Discovery of Active Substance till Arriving into the Pharmacy SUMMARY Radzevičienė V., Platonovienė R. Long Pharmaceutical Way Achieving the Patient: from Discovery of Active Substance till Arriving into the Pharmacy. The topic of this thesis on the creation of new medicine is very important not only for scientists, medical staff, but also for all the people who deal with the disease. It is a long and complex stage of synthesized chemicals, clinical laboratory analysis and financial resources. The clinical trials of drugs - new, more advanced and more effective medicine search for the final result, which provides opportunities to improve people's quality of life and extend their lifetime. Clinical trials are carried out on the basis of national, EU and WHO document provisions. The main objective of the thesis is to analize CT trends in Lithuania in 2004 – 2015. The aims of the thesis: 1. To investigate the clinical trials distribution by year which were carried out in Lithuania. 2. To carry out the clinical trials analysis according to the phases of the research, types of the design, investigational medicinal products, clinical research center, executors’ specialty and clinical research customers. 3. To assess the clinical research change trends in Lithuania. The methods of the thesis: According to SMCA open statistical data analysis, the secondary statistical survey was carried out and the clinical trial trends were analyzed in Lithuania in 2004 – 2015: the applications of clinical trials were registered on SMCA database: http://www.vvkt.lt/Metines-suvestines and the information about ongoing clinical trials was analyzed: http://www.vvkt.lt/Informacija-apie-vykstancius-tyrimus. The results: There were 1137 applications to execute CT in 2004 – 2015, 589 of them were submitted by CT customers and 3705 by execution center. 1012 licenses were issued to execute CT. It was ascertained that there was mainly carried out on III phase of CT, inpatient department and CT state research center. The CT were mainly carried out on oncology which were fulfilled by a large and well-known pharmaceutical companies. Conclusion: On the basis of 2004 – 2015 SMCA annual statistics, thoroughly analyzed CT applications, registered on SMCA website and ongoing CT change trends were analyzed. |