1．An Appropriate Implementation of Clinical Trials and Morality of Investigators / 薬剤疫学

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.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.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.

The Appropriate Interpretation of Recent Clinical Trials: How to Read RCT in the Era of Advertizing-based Medicine

Although evidence-based medicine (EBM) has changed medical therapy from experience- or experiment-based medicine to the modern science-based medicine, nowadays it seems to be used as a tool of advertizing strategy of industries. Clinical trial is a fundamental component of EBM and it costs very much and are mostly conducted by the financial support of pharmaceutical industries at a tremendous expense. If anticipated results for the sponsor were not shown in the trial, a "spin" has been used to mislead readers as if positive results for test drugs or devices were obtained by emphasizing subgroup analysis, or searching favorable endpoint by post-hoc analysis. Clinical trials on angiotensin receptor blocker (ARB) are continuing succession of defeat all over world except two Japanese clinical trials, JIKEI HEART and KYOTO HEART studies. However, in both trials, subjective soft endpoints, such as angina pectoris or congestive heart failure were used despite of prospective randomized, open labeled, blinded endpoint design. In the era of advertizing-based medicine, It is important to read clinical trial data with critical view points.