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Published on: April 6, 2019
Hospital Preparedness for Conducting Clinical Research During a Pandemic: A Nationwide Survey Among Designated
Kazuaki Jindai1, Hiroki Saito1, Eriko Morino1
1Kazuaki Jindai, MD, DrPH, is an Epidemiologist and Infectious Diseases Specialist, Department of Virology, Tohoku University Graduate School of Medicine, Sendai; and an Internal Medicine Physician, Meiseikai Healthcare Corporation, and AMR team lead, Allm Inc., Tokyo, Japan. Hiroki Saito, MD, MPH, PhD, is an Infectious Diseases/Critical Care Specialist and Researcher, Interdepartmental Division of Critical Care Medicine, Department of Medicine, University of Toronto, Toronto, Canada, and is associated with Department of Emergency and Critical Care Medicine, St Marianna University School of Medicine, Kawasaki, Japan. Eriko Morino, MD, is a Clinical Trial Specialist, Center for Clinical Sciences, National Center for Global Health and Medicine, and is associated with the Department of Respiratory Medicine, National Center for Global Health and Medicine, and the Department of Infectious Diseases, Keio University School of Medicine; all in Tokyo, Japan. Ryota Hase, MD, is an Infectious Disease Specialist and Chief, Department of Infectious Diseases, Japanese Red Cross Narita Hospital, Narita, Japan. Masaya Yamato, MD, PhD, is an Infectious Disease/Critical Care Specialist and Chief, Center for Infectious Diseases, Rinku General Medical Center, Izumisano, Japan. Miwa Sonoda, RN, MPH, is a Clinical Trial Specialist, Department of International Trials, National Center for Global Health and Medicine, Tokyo, Japan. Taro Shibata, MSc, is a Biostatistician and Chief, Biostatistics Division, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan. Tatsuo Iiyama, MD, is a Clinical Trial Specialist, Department of International Trials, National Center for Global Health and Medicine, Tokyo, Japan.
Abstract:
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.
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