Clinical trial registration database in Japan: recent trends in clinical trial registration in Japan

ABSTRACT

The clinical trial registration system was introduced in Japan for the purpose of ensuring the transparency of clinical trials, protecting subjects, and ensuring the quality of clinical trials, and began operating in 2005. Since 2008, the National Institute of Health Sciences has published a clinical trial information portal site, and submitted information to the WHO-International Clinical Trial Registry Platform (ICTRP). In 2014, the site was completely renovated to improve the usability for the users. The main features of the new portal site are divided into the general site, those for medical staff, and those in English, in terms of user site composition. The overall design has been improved to establish a feeling of warmth, the information contents, explanations of terms, etc., and collection of links have been expanded, and the search function has been enhanced by adopting various synonym dictionaries. In addition, the Clinical Trial Act came into force in 2018, and procedures based on this law will be required for research that evaluates this efficacy and safety of pharmaceutical products. Researchers are required to comply with clinical trial implementation standards and to conclude and publish contracts related to funding for pharmaceutical companies, etc. And the clinical trial reviewed by the Japan Certified Clinical Research Review Board (JCRB) must be registered in the Japan Registry of Clinical Trials (jRCT). This article provides an overview of this portal site, trends regarding the number of clinical trials registered since the start of domestic registration agencies, future challenges, and clinical trials related to COVID-19 that have been registered in Japan.