Clinical trials are strictly conducted in accordance with global standards, respecting the rights of trial subjects and closely monitoring for patient safety based on high ethical standards.
Clinical trials are essential for verifying the safety and efficacy of investigational products, and they must be performed with respect for the rights of trial subjects. At Chugai, clinical trials are closely monitored for patient safety, following stringent scientific methodology based on the highest ethical standards and scientific standards.
The Chugai Group has created standardized procedural manuals based on Japan’s Pharmaceutical and Medical Devices Act and other related legislation, as well as on the current revision of the Declaration of Helsinki*1 and ICH-GCP*2, which are global standards. We are committed to evaluating the true value of investigational products using well-established, reputable testing procedures.
Plans for clinical trials are first drafted by experts in fields such as medicine, statistics, and safety. The actual trials are implemented based on a written plan that has been fully reviewed both internally and by outside medical institutions to ensure that it is ethically and scientifically sound. Once a trial has begun, information on safety is promptly collected and analyzed, and when necessary, that information is shared with regulatory authorities and the medical institutions involved, ensuring that patient welfare always remains the highest priority. The quality of clinical trials is also carefully managed, with a variety of steps in place to ensure the reliability of trial results.
- *1.The “Ethical Principles for Medical Research Involving Human Subjects” first adopted at the World Medical Association in 1964. Biomedical research must ultimately include testing on human subjects in order to contribute to healthcare. The 1964 Declaration of Helsinki is the ethical foundation of modern clinical trials. (Source: The Pharmaceutical Society of Japan)
- *2.Good Clinical Practice (GCP) guidelines adopted by the International Conference on Harmonisation (ICH) for conducting pharmaceutical clinical trials in the European Union, the United States and Japan.
(Source: The Pharmaceuticals and Medical Devices Agency)