Abstract Japan Agency for Medical Research and Development (AMED), established in 2015, is a funding agency that aims to act as a ’control tower’ that directs integrated research, from basic research to practical application. Also, our goal is to fast-track medical R&D that directly benefit people, not only by expending lifespans, but also improving quality of life. So, to improve the quality of clinical researches, AMED conducted a preparatory survey on Patient and Public Involvement (PPI) in clinical researches, which includes comparative policy analysis on PPI strategies and activities in the UK and the US, questionnaire surveys and interviews to patient groups of cancer and rare/intractable diseases in Japan, and a discussion with the expert panel on PPI in Japan. Through this preparatory survey, we define the basic concept of AMED-PPI, and start to encourage PPI in clinical research from FY2019. The Basic Concept of PPI in AMED Definition AMED-PPI is an approach that researchers try to consider patient/public* knowledge and experience to improve the process of their clinical research * patient/public includes survivor, patient/survivor family and future patient Principles more useful findings/results to meet patients’ needs more fast-track clinical researches reduction of risks for research participants (patients) Significance for Researchers Researchers can get a new point of view and find values of their medical researches PPI makes research participants easier to understand the clinical research for Patients and Public PPI can improve convenience and understanding for the research participants PPI can lessen the knowledge and interest for between patients/public and researchers in medical R&Ds Patient and Public Involvement Guidebook (available only in Japanese) https://www.amed.go.jp/ppi/guidebook.html