The perspectives on the clinical trials in South Korea under the impact of the global COVID-19 pandemic: the difference between trial site and sponsors

Abstract Background During the COVID-19 pandemic, novel clinical trial methods known as decentralized clinical trials (DCTs) were rapidly introduced. The differences in operation of clinical trials including DCT perspectives during the pandemic between site and sponsors were investigated. Methods The effect of the COVID-19 pandemic on clinical trials was investigated for a society of sponsors and a trial site in South Korea. The current difficulties and future perspectives on clinical trials were assessed and compared between the site and sponsors. Results Both the site and sponsors reported on their experiences with the challenges of conducting clinical trials in the pandemic era. While 64% of personnel from the site judged that the difficulties were solved by their own solution, 67.6% of personnel from sponsors considered cooperation with trial sites as a key solution to overcome the difficulties. While half of the personnel from the site were skeptical of the changes in trial operation methods, the sponsors expect the institutionalization of DCT elements. Conclusions With varying attitudes, sponsors and sites attempted to overcome the challenges of conducting clinical trials during the pandemic era. To conduct clinical trials, both sponsors and sites must work closely together to find solutions with efficient communication. For the successful implementation of new tools such as DCT, the government needs to solicit support from sponsors and sites and change regulations.