Implementation of Japan's First Clinical Research Regulatory Law: Background, Overview, and Challenges.
- LawHEC forum : an interdisciplinary journal on hospitals' ethical and legal issues
An overview of Japan's first law regulating clinical research and its background is offered, and its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field are discussed.
The Diovan scandal in Japan; don’t let bygones be bygones
- MedicineJournal of Human Hypertension
It is found that even among the authors involved in the Diovan scandal, 58% of them continued to receive money from pharmaceutical companies even after the divulgence of the scandal, and the Clinical Trials Act was enacted in 2018 as a law that demands official procedures in physicianinitiated clinical trials, which requires strict monitoring and transparency of conflicts of interest.
The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective
- Medicine, Political ScienceFrontiers in Medicine
Clinical research in Japan must be conducted appropriately while adapting to these various changes in the external environment and legal framework, as it requires increased financial and human resources for all stakeholders.
A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan
- Political Science, MedicineDrug design, development and therapy
The problem of drug lag still lingers on despite several regulatory system revisions, while the solution is incompatible with the elimination of Yakugai because the lag potentially reduces the risk of unpredictable adverse events.
Regulatory changes after the enforcement of the new Clinical Trials Act in Japan
- MedicineJapanese journal of clinical oncology
The enforcement of the new Clinical Trials Act was supposed to improve the reliability of academic clinical trials in Japan; however, the financial and administrative burden may reduce clinical trial activity in the years to come.
Overview of the ethical guidelines for medical and biological research involving human subjects in Japan
- Medicine, Political ScienceJapanese journal of clinical oncology
The regulations of academic clinical research in Japan, the history of ethical guidelines and the three major changes introduced in the New Integrated Guidelines in 2021 are discussed.
Scientific Misconduct and Social Media: Role of Twitter in the Stimulus Triggered Acquisition of Pluripotency Cells Scandal
- MedicineJournal of medical Internet research
This study investigated the discussions on STAP cells on Twitter and content of newspaper articles in an attempt to assess the role of social compared with traditional media in scientific peer review.
Delivering Future Clinical Trials in Rheumatology
- MedicineThe Journal of Rheumatology
While many innovations in disease management have emerged from recent rheumatology trials, important clinical problems remain to be solved and a brief list of what trials can achieve is highlighted.
Are Japanese Randomized Controlled Trials Up to the Task? A Systematic Review
- Medicine, Political SciencePloS one
The characteristics and quality of Japanese RCTs and factors related to their quality were assessed and surgical intervention studies for external causes of morbidity and mortality with a large sample size, trial registration and a large number of arms were most likely to be of higher quality.
Payments From Pharmaceutical Companies to Authors Involved in the Valsartan Scandal in Japan
- Medicine, Political ScienceJAMA network open
Study finding suggest that clinical trial practitioners received large payments from the pharmaceutical industry even after the unprecedented scandal.
SHOWING 1-5 OF 5 REFERENCES
The Unintended Consequences of Clinical Trials Regulations
- MedicinePLoS medicine
The International Conference on Harmonisation guidance on good clinical practice (GCP) is argued to be having a disastrous effect on noncommerical randomized clinical trials in Europe.
Japan. Tampered data cast shadow on drug trial.
A clinical trial led by cardiologist Hiroaki Matsubara indicated that the blockbuster hypertension drug valsartan lowers the risk of stroke and angina for some patients; however, a university investigation concluded that data had been manipulated and the paper was retracted.
RETRACTED: Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study
- MedicineThe Lancet