Monitoring the effect of medicinal product therapy - a review of the legal framework and analysis of real world data

Monitoring the effect of medicinal product therapy - a review of the legal framework and analysis of real world data

Oral presentation

Nedelko Nedelkov1,3, Boryana Ivanova3, Desislava Byalkova3, Mihail Jekov4, Alexandra Savova2,3, Manoela Manova2,3, Ilko Getov2,3;
1Faculty of Chemistry and Pharmacy, Sofia University "St. Kliment Ohridski, Sofia, Bulgaria;
2Faculty of Pharmacy, Medical University Sofia, Bulgaria;
3National Council on Prices and Reimbursement of Medicinal Products, Sofia, Bulgaria;
4Sqilline, Danny Platform - analytical platform for real-world data, Sofia, Bulgaria

Aim of the study is to review and analyse the legal framework for the monitoring the effect of medicinal product therapy in Bulgaria, carried out by the National Council on Prices and Reimbursement of Medicinal Products. Secondary objectives: to analyse and present the technical solutions implemented and used (Danny Platform analytical platform) for the monitoring and analysis of clinical data, real-world data (RWD) and comparative analysis with clinical trial (CT) data. Materials and methods: We conducted a documentary content analysis of the legal framework, as well as an analysis of the specifics of the technical implementation and the obtained RWD for medicinal products. Results and discussion: Conducting CTs is an essential and mandatory condition for establishing the quality, efficacy and safety of new medicinal products, as a condition for them to be authorised and marketed. Once the medicinal products start to be used in real-world clinical practice, they reach patients who have different genetic characteristics, comorbidities and take different medicinal products. The quality, efficacy and safety data of medicines demonstrated in CTs may differ substantially from RWD data. The use of software solutions such as "artificial intelligence (AI)" allows for the processing of large volumes of data, eliminating errors and unifying the information obtained by medical-treatment establishments. The study shows that the use of RWD allows in-depth analysis of both better and worse outcomes compared to CT data in effect monitoring.
Keywords: Monitoring the effect of therapy, clinical trials, real-world data (RWD)