1．An Appropriate Implementation of Clinical Trials and Morality of Investigators

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  • KUWAJIMA Iwao
    Japanese Organization of Clinical Research Evaluation and Review, Japan

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  • 1．Clinical trial (臨床試験) から Criminal trial (裁判) へ　―ディオバン臨床研究不正事件とは―
  • Clinical trial(臨床試験)からCriminal trial(裁判)ヘ : ディオバン臨床研究不正事件とは
  • Clinical trial(リンショウ シケン)カラ Criminal trial(サイバン)ヘ : ディオバン リンショウ ケンキュウ フセイ ジケン トワ

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Abstract

<p>Needless to say, an evidence from the clinical trial is fundamental factor of evidence-based medicine （EBM). However, most of large-scale trials were financially supported by drugindustry companies. As an excursion of large-scale clinical requires huge costs, drug company expects the favorable result for the their test drug. If result fell short of their expectation, sponsored industry try to take some measures, such as the withdrawal of the financial support, or spread the interruption fulfilled with SPIN favoring secondary endpoint in the advertisement.</p><p>Recently valsartan related Japanese trials, KYOTO HEART study, which published a too good to be true data, suspected fabricated results and Novartis and ex-employee were charged with false advertising in July 2014. Tokyo District Court ruled that the defendants manipulated clinical evidence in favor of valsartan, although the judge ruled them not guilty on grounds that academic papers were not considered a form of advertising. Several reasons for the misconduct can be raised. Firstly, morality of both investigator and pharmacy were lacking. Secondary, knowledge of investigators about clinical trials and statistics were scarce too much. Thirdly, clinical studies have been started in the circumstance in which insufficient infrastructure development of Japan.</p><p>Valsartan scandal led to system changes. The Diet enacted a law aimed at boosting the transparency of clinical research funded by pharmaceutical companies. Research will require to be prescreened by a government accredited committee and ethic committee in the research institution.</p>

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