AstraZeneca Signs Master Clinical Study Agreement with Keio University To Counteract â€˜Drug Lagâ€™
Keio University School of Medicine, based in Shinjuku-ku, Tokyo, and AstraZeneca K.K., the Osaka-based subsidiary of AstraZeneca, today announced a Master Clinical Study Agreement. Separate project agreements on future clinical trials involving the two parties will be concluded independently under this master agreement.
The agreement has been signed against a background of the recent severe environment for clinical trials in Japan. This has caused a huge time difference - the so-called â€˜drug lagâ€™ - compared to the US and Europe, in terms of the time when new medicines become available for prescriptions, which has become a social problem.
In order to make better medicines available for use as soon as possible, it is vital for medical institutions and pharmaceutical companies to select medicines in areas of high unmet need and promptly proceed with clinical development while keeping close communications with each other.
Keio University School of Medicine has just begun an effort to build up clinical trials and clinical research, and will have discussions with AstraZeneca as part of this effort under this agreement. The university will also support early conduct of clinical trials of candidate compounds in the companyâ€™s pipeline. At the same time, it is the universityâ€™s intention to reduce the time required to undertake and conclude clinical trial contracts to contribute to earlier commencement and enhanced efficiency of clinical developments in Japan.
Additionally, Keio University School of Medicine and AstraZeneca will enhance interaction between their experts in therapeutic areas and will try to build close relationships not only for clinical trials but also for exploratory research and translational research