The influence of the regulatory system on the study design and data management practices in clinical trials
The aim: To review real-life regulatory-dependent study design and data management practices of post marketing multicenter studies of medical devices conducted in 2021 in Ukraine and Poland. Materials and methods: This article presents the case study of 4 post marketing multicenter studies of medical devices conducted in 2021 in Ukraine and European Union. Results: The case study presented effective cross-border cooperation between Ukrainian and European actors. Despite the gaps in Ukrainian legislative framework on medical devices, complex solutions on employment of the most stringent regulatory provisions led to appropriate study design. Usage of the highly compliant electronic data capture led to fast-track study start-up and solid clinical data collection. Conclusions: Publications on real-life regulatory-dependent clinical trials conduct might be essential to innovate the regulatory system in Ukraine. The cross-border cooperation might assist the advancement of clinical trials industry in Ukraine. Gaps in medical devices regulations in Ukraine impede the context-specific clinical trials solutions for biotech industry in Ukraine. The regulatory framework and practice in Ukraine may be perceived as externally driven due to gaps in medical devices regulations, lack of capacities of domestic notified bodies and business interests of Sponsors.
clinical trials design, medical devices, clinical trials regulation, clinical data management, article
Yashchenko M. The influence of the regulatory system on the study design and data management practices in clinical trials / Yashchenko M. V., Yurochko T. P., Soroka I. M. // Wiadomosci Lekarskie (Warsaw, Poland : 1960). - 2022. - Vol. 75, Issue 5. - P. 1192-1196. - https://doi.org/10.36740/WLek202205125