Hospital Preparedness for Conducting Clinical Research During a Pandemic: A Nationwide Survey Among Designated Medical Institutions for Infectious Diseases in Japan.

In Japan, the Infectious Disease Control Law designates certain institutions across the country as medical institutions for infectious diseases, with the role to respond to and prepare for epidemic or pandemic infections. Since the early stages of the COVID-19 pandemic, these designated medical institutions have provided clinical care to patients with COVID-19. While these institutions primarily handle clinical care, they are also well poised to conduct rigorous clinical research that is needed to address future health emergencies. The COVID-19 pandemic highlighted the importance of clinical research as a medical countermeasure through its role in the development of effective novel vaccines and therapeutics. Under the Japanese system, designated medical institutions that cared for patients with COVID-19 had the privilege to access the earliest cases and were uniquely positioned to contribute to scientific evidence. Based on this understanding, we conducted a nationwide survey and analyzed data from 100 designated medical institutions to better understand their experiences and involvement in clinical research during the COVID-19 pandemic and their readiness and willingness to conduct clinical research in a future health emergency. While quite a few institutions showed willingness to participate in infectious disease research in the event of a future health emergency, it was evident that many would require additional expertise and financial support to facilitate such research. Our analysis suggests that further capacity development, empowerment for clinical research, and a strong collaborative network across stakeholders are required to improve pandemic response and preparedness in Japan.