The Department of Clinical Research Support supports our research strategy and protocol development across a wide variety of areas. It aims specifically at translating scientific discoveries into clinical applications (translational research), investigator-initiated new drug application (NDA) trials, and investigator-initiated non-NDA trials. We have already supported a number of Phase 1 trials and the early exploratory phase of an investigator-initiated NDA trial.
The Department of Clinical Research Support provides operational support in areas such as project management, regulatory affairs, and the development of protocols and study-related documentation. We have been supporting NCNP investigators conducting first-in-human clinical trials from the early planning stage of the project.
NCNP has established frameworks that help improve the quality of the studies NCNP conducts. Clinicians, physician scientists, a statistician, and TMC clinical research professionals follow these frameworks in their comprehensively review of clinical study protocols, especially those involving the use of unauthorized pharmaceuticals/devices and the development of new indications for use.
In international collaboration with the TREAT-NMD alliance, we have established Remudy, which runs three official national registries for dystrophinopathy, GNE myopathy, and myotonic dystrophy. The myotonic dystrophy registration was recently launched in collaboration with Osaka University and several institutes in the National Hospital Organization. The aim of Remudy is to develop clinical research infrastructure and accelerate clinical development research for these rare diseases in Japan. To date, we have provided data sets for feasibility studies in response to inquiries, sent out information on clinical trials to the candidates in preparation for recruitment phases and, implemented a new ‘registry-based’ research format to present the natural history and epidemiological data of rare diseases. Remudy provides a prototype clinical research infrastructure to help efforts to overcome these rare and incurable diseases. Recently, Remudy started operating a user-friendly, secure web-based registry system designed to help registered patients update their data and cooperating physicians to follow their progress easily.
Our Extra Early Exploratory Clinical Trial Unit (EEECTU) in the Department of Clinical Research Support was established in 2012 to prepare and support the establishment of Cluster Ward, a specialized medical unit for clinical trials and research, based at our National Center Hospital. Cluster Ward was constructed as a separate research building at NCNP’s National Center Hospital in 2011 and started its activities in January 2012. EEECTU supports the operation and management of Cluster Ward and promotes high quality clinical research in this dedicated setting.
Important studies that are being conducted in Cluster Ward include investigator-initiated trials, international clinical trials and research studies involving complicated and specialized evaluations, bioresources collection studies connected with the National Center Biobank Network, some cognitive behavioral therapy studies, and neuropsychiatric studies requiring specialized evaluations conducted in collaboration with the Early Detection and Intervention Center for Schizophrenia (EDICS). Together, EEECTU and Cluster Ward contribute to maintaining the infrastructure needed for NCNP to run prospective clinical research and afford NCNP its position as a unique Japanese national center.