Takahiro Kiuchi 1) , Takeo Nakayama 2)
1)Department of Health Communication, Graduate School of Medicine, The University of Tokyo
2)Department of Health Informatics, Graduate School of Medicine, Kyoto University
Takeo Nakayama
1) Department of Health Informatics, School of Public Health and Graduate School of Medicine, Kyoto University
2) Department of Ethics Support, Kyoto University Hospital
Data sharing of research results is promoted for the purpose of deriving new knowledge through the secondary use of valuable data, deterring research misconduct, and posteriori verification. Guidelines issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare define fabrication, falsification, and plagiarism as three specific types of misconduct, which are subject to investigation when misconduct is suspected. The current article discusses data sharing from the perspective of research integrity and publication ethics, and the need for careful discussion from the perspective of research security. The International Committee of Medical Journal Editors requires authors to provide clinical trial data sharing plans and secondary analyses to give appropriate credit to primary researchers. Although the perception of data sharing is heavily influenced by funding agency guidelines, many academic journals still do not include guidelines for data sharing in their “instructions for authors.” Meanwhile, the Ministry of Education, Culture, Sports, Science and Technology has announced a policy to promote information security enhancement by introducing risk assessment in critical technology fields. To balance international collaboration and economic security, the ministry has established a new International Policy Division and intends to expand the scope of its activities to include areas such as artificial intelligence. Government agencies in the United States are also formulating guidelines and laws to prevent “inappropriate foreign influence.” It is necessary to raise domestic awareness of this issue and plan appropriate steps while considering such international trends.
Koji Oba
Interfaculty Initiative in Information Studies, The University of Tokyo
Data sharing plays a crucial role not only in ensuring transparency in research findings but also in advancing medicine and scientific progress. In recent years, the development of various data-sharing platforms has facilitated the exchange of individual participant data (IPD), leading to significant contributions in clinical research. From a statistical perspective, the benefits of utilizing IPD have been extensively discussed, particularly in meta-analysis, where IPD-based approaches offer statistical advantages over traditional analyses relying solely on published aggregate data. These discussions provide valuable insights into the potential applications of IPD through data-sharing initiatives. The current article focuses on data sharing in clinical trials and clinical research, with a particular emphasis on recent advancements achieved through IPD sharing. The findings of previous studies examining data sharing in clinical trials and clinical research are summarized, highlighting recent achievements and statistical perspectives on the use of shared IPD.
Takahiro Kiuchi
1)Department of Health Communication, Graduate School of Medicine, The University of Tokyo
2)UMIN Center, The University of Tokyo Hospital
【Introduction】Data sharing of clinical trials and epidemiological research is recognized as highly important for obtaining new findings through re-analysis of data and conducting meta-analysis, as well as validating existing statistical analysis, especially in Europe and America. 【Current status of UMIN Individual Case Data Sharing】The UMIN Individual Case Data Sharing system in Japan is a data sharing site that accommodates research data, research plan documents, and manuals for data specifications. Currently the site contains 456 research projects for which research data are registered, and 306 research projects for which all three of these items are registered. These numbers are relatively small compared with all of the research projects that have recently been performed in Japan. 【Discussion】Although member journals of the International Committee of Medical Journal Editors require their contributors to submit “data sharing plans” with manuscripts for publication, plans that include “no data sharing” are permitted. However, research funding organizations in Europe and America are gradually making data sharing obligatory for funded research. In the 2024 fiscal year, the Japanese government began to require their research fund recipients to submit data sharing plans for all funded research.
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