The scenario of clinical research after the COVID-19 pandemic: assessment of regulatory aspects based on Anvisa

Abstract

Clinical research is a study with human subjects to test the efficacy and safety of an intervention. The phase III study, as it has a larger number of participants and has more controls, is the main study to be presented as proof of efficacy and safety in registering products with Anvisa. With the advent of the global Covid-19 pandemic, it was possible to observe a significant increase in clinical studies being carried out worldwide. For this, this study was divided into three parts i. quantitative assessment of the attractiveness of studies in Brazil after the Covid-19 pandemic; ii. qualitative assessment of studies in Brazil after the Covid-19 pandemic, describing their main characteristics; iii. to assess whether the drugs registered in Brazil, for Covid-19, had their clinical trials carried out with an arm in Brazil. In this analysis, it was possible to identify that, in Brazil, the number of clinical trials increased, but not significantly. However, analyzes of DDCMs and DEECs, considering drugs indicated for Covid-19, by Anvisa, increased by more than 100%, reinforcing that clinical research carried out in Brazil, during this period, had the interest of registering drugs or changing their bulls.