2024/3/26
Shizuoka Cancer Center
The newly established clinical division called “the Division of Early Clinical Development” has just been launched (April 1, 2024) at the Shizuoka Cancer Center. This is a cross-organ division involving multiple clinical divisions for developing early phase cancer treatments.
Early phase development of a new drug including anti-cancer drugs (i.e., Phase I Clinical Trial) is critical as the initial step in the development and has been carried out only at the facilities where specialized knowledge and experiences can be applied. However, the number of such facilities remains small and insufficient in Japan. The development needs the world-class speed in order to overcome what they call “a drug lag” and provide patients with new drugs having proven efficacies.
Phase I Clinical Trial, which is the very first step of an early clinical development, is carried out by administering a small portion of a drug to start with, and the dose is gradually increased along with the safety confirmation each time. The information including side effects, efficacy, absorption, metabolism, and evacuation is constantly collected before deciding on the most suitable dose. Among the phase I clinical trials, a trial to apply a drug to human for the first time is called the First in Human (FIH) trial. It is done as an “all-comer test,” which involves any types of cancer or organ in most cases, not focusing on a particular type of either. Therefore, it needs to be subject to a variety of malignancy types including cancer in the head and neck region, lung cancer, breast cancer, gastrointestinal cancer, hepato-biliary-pancreatic cancer, gynecologic cancer, urinary cancer, and sarcoma. Naturally it requires a systematic management in a cross-organ manner, not completing it with a management within a certain clinical division. Also required is a performance by a multidisciplinary team consisting of doctors from each clinical division, nurses, clinical research coordinator (CRC), pharmacists, and lab technicians. They are supposed to share the information constantly to provide a treatment. This new division is to integrate all the cross-organ early phase treatments, thanks to the participations by 14 doctors from 10 clinical divisions including Thoracic Oncology, Gastrointestinal Oncology, Gynecology, Dermatology, etc., and CRC. In addition, the staff from the Department of Pharmacy, Division of Pathology, Division of Diagnostic Radiology, and Department of Nursing are also participating and contributing. Other than these participating members, several certified nurses for drug treatment will be stationed at a ward allocated for the trials. Meanwhile, the phase I clinical trials for specific cancer types will continue to be carried out at each relevant clinical division just as it has been done before.
