4．History and Future Direction of Academia Clinical Trial Regulation : Lessons of Diovan Affairs and Concerns on Clinical Trials Act / 薬剤疫学

ABSTRACT

Clinical trials play a crucial role in the development of new medical technologies and optimization of current treatments. Because the results directly affect medical practice, the trials must not be harmful both to the current and future patients, which is ensured by their scientific validity and data credibility. Inversely, fake trials deceive and mislead people, representing serious threats to the public welfare.In 2013, series of misconduct were revealed for Diovan trials, where false results were derived and published, based on made up data. Although futile efforts were devoted to pursue responsibility of relevant researchers and pharmaceutical company, the essential cause was lack of the rule to ensure reliability of clinical studies in academia. Indeed, importance of data credibility, which is a prerequisite of clinical science, was not stipulated in the clinical study ethical guideline, allowing for the spread of studies with poor quality and/or malpractice.Spurred by the Diovan affairs, national arguments tardily took place regarding reliability of academia trials, leading to the implementation of “Clinical Trials Act”. Although the law will improve reliability of academia trials, several concerns exist, as it ignores external consistency and harmonization with other laws. Most seriously, it lacks the mechanism to translate study achievements to the tangible benefits for people.Namely, no matter how good results were obtained by studies under the law, they would not lead to the regulatory approval, due to the lack of link with pharmaceutical affairs law. Then, there rises a doubt on the spirit of law, regarding whether it really aims to improve current medicine. Indeed, the driving force of clinical trial is the hope of medical staffs, to palliate the pain of patients and families, if not this time, but next time in the future. This is the cause of clinical trials, where we must return, in order to reward the heart of medicine and clinical trials, for the improvement of academia clinical trial regulation.