Impact of COVID-19 on clinical trials protocol amendments

Abstract

Introduction: The COVID-19 pandemic situation had a great impact on all spheres of people’s lives. It also affected clinical trials as Sponsors, sites and investigators faced a number of problems, such as systematic IMP taking, adherence to protocol visits, efficacy evaluations, laboratory procedures, and analyses. Materials and Methods: The amendments issued in 2020 were compared with the amendments issued in the previous three years 2017-2019. The literature about COVID-19 and its impact on clinical trials were analyzed. Clinical trial protocol amendments published in 2020 were studied to evaluate pandemic influence on ongoing clinical studies. Statistical processing of the results was carried out using the correlation analysis. Results:  The highest quantity of amendments was released in 2020 –14 (36%). Fewer amendments came out in 2019 – 13 (33%), in 2018 – 9 (23%), and the fewest amendments were issued in 2017 – 3 (8%).  Conclusion: The existing system of clinical trial protocol creation is dependable and adequate. It allows reacting flexibly to unexpected challenges, like COVID-19, fully complying with the prescribed procedures and carefully observing participants’ safety and well-being. That is why the current pandemic did not affect the number of protocol amendments. Graphical Abstract