Patient and public engagement in clinical trials

Abstract

Abstract Clinical research involves the study of people, data or human tissue samples in order to understand health and disease while seeking new and better ways to detect, diagnose, treat and prevent disease. Current global statements support patient and public involvement (also known as PPI or patient engagement) in a range of research activities, including clinical research. These activities include helping to develop research questions, working on advisory groups and/or disseminating research findings. During the dialogues or focus groups, we can combine benefit and risk assessments by professionals with benefit and risk assumptions by lay people; the best way to select participants, the bearable levels of risks and burdens as well as desirable methods for informing participants of the side effects and possible direct benefits. Japan Agency for Medical Research and Development (AMED) began to introduce PPI in 2017, the first comprehensive policy for the country. However, there is no data regarding attitudes about of researchers with PPI in Japan. We conducted cross-sectional online surveys with AMED-funded principal investigators in order to know the current views from researchers about PPI. We would like to discuss benefits of PPI and issues to be solved from our survey results.