Comparison of the characteristics of healthy volunteers participating in Phase 1 clinical trials in Korea and Japan.

Abstract

This paper aims to elucidate the characteristics of healthy volunteers in Korea and Japan. Clinical trials can be divided into Phases 1 through 4 based on the stage of research. Unlike other phase, Phase 1 trials administer new drugs to healthy volunteers. Although Phase 1 trials are the first stage of drug administration to humans, without therapeutic purposes. Healthy volunteers must have no history of diseases that could affect the study and must have normal physical measurements. They are also defined as individuals who understand the study and can voluntarily consent to participate. Also, it is crucial to conduct them ethically. To date, there has been insufficient research on the Phase 1 clinical trials in Korea and Japan, and in-depth analysis of the perceptions and the motivations. This study enrolled healthy volunteers in Korea and Japan to conduct surveys related to demographic information and their perception.