History of academia clinical trial regulation: the background on the clinical trials act

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  • Kakei Yasumasa
    Clinical and Translational Research Center, Kobe University Hospital Department of Oral and Maxillofacial Surgery, Kobe Graduate School of Medicine
  • Nagai Yoji
    Clinical and Translational Research Center, Kobe University Hospital
  • Hasegawa Takumi
    Department of Oral and Maxillofacial Surgery, Kobe Graduate School of Medicine
  • Akashi Masaya
    Department of Oral and Maxillofacial Surgery, Kobe Graduate School of Medicine

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Other Title
  • アカデミア臨床研究環境のこれまで
  • ～臨床研究法施行の背景～

Abstract

The clinical research environment in Japan has changed significantly in recent years. In particular, the enforcement of the Clinical Trials Act on April 1, 2018 is considered a major turning point. One of the reasons for this change is that several inappropriate clinical research cases, such as the Diovan affairs, occurred between 2013 and 2014. In those cases, the relationship between researchers and pharmaceutical companies, involving data manipulation, opaque scholarship endowments and several university institutions, attracted attention and became a social issue. In light of these research irregularities, the Ministry of Health, Labour and Welfare （MHLW） concluded that laws and regulations were necessary to restore trust in clinical research, and after revising and tightening the ethical guidelines, the Clinical Trials Act came into effect. <br>While all those involved in clinical research must understand the requirements of this law and respond appropriately, the burden on researchers has increased significantly due to the large number of documents and complexity of this law, leading to the stagnation and delegitimization of clinical trials. The major features of this law are that: the responsibility for clinical research has been consolidated in the hands of the principal investigator, researchers must submit their study plans to the MHLW through the Certified Review Board approved by the MHLW, and the flow of conflicts of interest has been defined in detail. <br>This report describes the history of changes in clinical trial regulations in the clinical research environment up to the passage of the Clinical Trials Act in clinical research ethics, and outlines the Clinical Trials Act.

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