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

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.

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Publication Details

Journal
Translational and Clinical Pharmacology
Published
2025-01-01
DOI
https://doi.org/10.12793/tcp.2025.33.e16
Primary Topic
Ethics in Clinical Research
Type
article
Field-Weighted Citation Impact
0.00

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article

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

Eun Kyung Choi, Ock-Joo Kim, Mika Maeda, Ildae Song et al.
Translational and Clinical Pharmacology
Ethics in Clinical Research
article

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

Eun Kyung Choi, Ock-Joo Kim, Mika Maeda, Ildae Song, Yuji Kumagai, Ji‐Eun Park, Ji-Hye Seo
article en

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.

Translational and Clinical PharmacologyVol. 33(3)
Kyungsung University (KR), New Generation University College (ET), Korea Institute of Oriental Medicine (KR), Kyungpook National University Medical Center (KR), Kitasato Institute Hospital (JP), Pusan National University (KR), Kitasato University (JP)
Korea National Institute for Bioethics Policy
Openalex Percentile: Top 64%
Ethics in Clinical Research
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