How to build a better clinical trial ecosystem for future infectious disease emergencies in Japan: Findings from a narrative review and stakeholder meetings.

The COVID-19 pandemic posed a serious challenge to national and global pandemic preparedness and response (PPR). Timely identification and development of diagnostics, therapeutics and vaccines through prompt evidence generation from clinical trials was recognized as an important health security agenda. In 2022, under the guidance of Japan Ministry of Health, Labour and Welfare (MHLW), a health policy research team was convened to analyze the COVID-19 related clinical trial ecosystem in the context of PPR in Japan and abroad with a focus on clinical trials for therapeutics. The research mainly composed of the following: a narrative review of relevant peer reviewed journals and grey literature, interview of global experts and stakeholders including those from the United States and the United Kingdom, and a culminating meeting in Japan with various stakeholders. Based on the outcomes of this research, the team makes the following three recommendations: (1) Strengthen the leadership group's role in infectious disease clinical trials, (2) Promote sustained coordination and collaboration among stakeholders, and (3) Apply innovative clinical trial designs and create an enabling research environment. Clinical trials, as a public health good, must be further integrated into healthcare. The team advocates for the implementation of these recommendations at the policy level to help improve the clinical trial ecosystem for future health emergencies in Japan.