Ito Tatsuya
Department of Experimental Therapeutics, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
PLoS One. 2016 Feb 5;11(2):e0148455. doi: 10.1371/journal.pone.0148455. eCollection 2016.
Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs). In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs.
The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries.
Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data.
New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants.
There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.
2003年日本《药事法》修订后，研究人员被允许开展研究者发起的试验（IIT）。然而，在随后的几年里，IIT的数量仍然很少。在亚洲其他国家以及欧洲、北美和南非，过去十年中IIT的数量有所增加。日本与其他国家IIT的特征差异尚不清楚。一些研究根据注册数据库分析了所有临床试验的特征，但针对IIT的研究较少。
本研究旨在分析ClinicalTrials.gov注册库以及日本三个注册库中IIT的特征，以确定日本与其他国家IIT的差异。
使用汤森路透制药™，识别2010年由学术界和政府发起并在ClinicalTrials.gov注册的作为IIT的试验。在日本的三个注册库中识别2004年至2012年的IIT：大学医院医学信息网络临床试验注册库、日本制药信息中心临床试验信息库以及日本医学协会临床试验中心临床试验注册库。对试验目的、阶段、参与者、设盲、分组、设计、对照和其他数据进行了描述。
2010年在ClinicalTrials.gov注册的新的和修订的IIT平均约占所有主办方认定试验的40%。IIT几乎都是参与者数量较少的早期研究。在8年的时间里共发现了56项日本IIT，这些也几乎都是参与者数量较少的早期研究。
在IIT的特征方面，日本与其他国家似乎没有太大差异。这些结果应促使对日本的IIT环境进行新的审视。
