Scientific misconduct in sponsored clinical trials in Japan: published cases are the “tip of the iceberg”

Author:

HIRAYAMA Kiyomi1,KURANARI Masae2,WAKUDA Hirokazu3,OTANI Naoyuki1,IMAI Hiromitsu4,UEMURA Naoto1

Affiliation:

1. Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hazama-machi, Yufu, Oita 879-5593, Japan

2. General Clinical Research Center, Oita University Hospital, 1-1 Idaigaoka, Hazama-machi, Yufu, Oita 879-5593, Japan

3. Clinical Pharmacology Center, Oita University Hospital, 1-1 Idaigaoka, Hazama-machi, Yufu, Oita 879-5593, Japan

4. Department of Medical Ethics, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hazama-machi, Yufu, Oita 879-5593, Japan

Publisher

AMED iD3 Catalyst Unit

Reference32 articles.

1. 1. National Institutes of Health, Office of Extramural Research. NIH Central Resource for Grants and Funding Information. https://grants.nih.gov/policy/research_integrity/what-is.htm [accessed February 19, 2022].

2. 2. Korenman, S. G. Teaching the responsible conduct of research in humans. https://ori.hhs.gov/education/products/ucla/chapter1/page02.htm [accessed February 19, 2022].

3. 3. George, S. L. and Buyse, M. 2015. Data fraud in clinical trials. Clin. Investig. (Lond.) 5: 161–173.

4. 4. Sheehan, J. G. 2007. Fraud, conflict of interest, and other enforcement issues in clinical research. Cleve. Clin. J. Med. 74 Suppl 2: S63–S67, discussion S68–S69.

5. 5. Titus, S. L., Wells, J. A. and Rhoades, L. J. 2008. Repairing research integrity. Nature 453: 980–982.

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