Current regulatory systems for clinical trials in Japan: Still room for improvement

H. Yanagawa
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引用次数: 6

Abstract

Abstract A main characteristic of the regulatory environment for clinical trials in Japan is that governmental regulations only apply to trials required for the approval of drugs or medical devices. Investigator-initiated clinical trials outside this registration scheme, such as large-scale trials to establish evidence for already approved drugs, are conducted based on government guidelines without corresponding laws. The Japanese adoption of Good Clinical Practice in 1997 and the governmental clinical trials vitalization plans instituted in 2003 have led to the improvement of infrastructure for registration trials, and this has in turn improved registration trial speed and quality. Global trials, rather than strictly domestic trials, are now prevailing. In contrast, problems associated with investigator-initiated trials conducted outside registration trial requirements were recently exposed by a scandal concerning a study of the anti-hypertensive drug valsartan. After the drug was launched, secondary benefits were reported in several academia-initiated clinical trials; these results proved to be fraudulent and the articles were retracted. This scandal threatens the reputation of Japanese drug trials and highlights the lack of scrutiny such trials have in terms of the potential conflicts of interest. To combat this issue, Japan has begun to establish new guidelines and a regulatory infrastructure to enhance the reliability of investigator-initiated clinical trials.
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日本临床试验的现行监管制度:仍有改进的余地
日本临床试验监管环境的一个主要特点是,政府法规仅适用于批准药物或医疗器械所需的试验。在这一注册计划之外,研究者发起的临床试验,如为已批准的药物建立证据的大规模试验,是根据政府指导方针进行的,没有相应的法律。日本于1997年采用了良好临床实践,2003年制定了政府临床试验振兴计划,这导致了注册试验基础设施的改善,这反过来又提高了注册试验的速度和质量。目前流行的是全球试验,而不是严格意义上的国内试验。相比之下,在注册试验要求之外进行的研究者发起的试验的相关问题最近因一项关于抗高血压药物缬沙坦的研究丑闻而暴露出来。该药物上市后,在几个学术界发起的临床试验中报告了次要益处;这些结果被证明是伪造的,文章被撤回。这一丑闻威胁到日本药物试验的声誉,并突显出此类试验在潜在利益冲突方面缺乏审查。为了解决这一问题,日本已经开始建立新的指导方针和监管基础设施,以提高研究者发起的临床试验的可靠性。
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