2022 Volume 4 Issue 2 Pages 30-36
Although cases of research misconduct in sponsored clinical trials have been sporadically reported, no systematic reviews or national surveys on this topic have been conducted in Japan. Thus, this study aimed to: 1) systemically review publicly available information on scientific misconduct reported through sponsored clinical trials, and 2) carry out a national survey to examine incidents of scientific misconduct using the following three approaches. First, a systematic review of publicly available information on scientific misconduct using Google search, Japan Medical Abstracts Society database, and PubMed.gov; second, a survey of sponsors using an anonymous web questionnaire; and third, a national survey of clinical research coordinators (CRCs) using an anonymous web survey by snowballing sampling. The systematic review identified five cases of misconduct; however, all five cases were already well-recognized in the public domain. In the survey of sponsors, five of the 12 sponsors responded that they had reported other cases to PMDA. In the national survey of CRCs, 22 of 164 (13.4%) responders reported being aware of at least one instance of “fabrication or falsification” in the past three years. These data suggest that not all instances of misconduct in sponsored clinical trials in Japan had been reported to PMDA and that not all instances reported to PMDA had been disclosed to the public. The publicized cases represent only the “tip of the iceberg.” A centralized process for reporting instances of scientific misconduct to Japanese regulatory authorities with pertinent public disclosure may improve the quality of clinical trials.
