Department of Clinical Research
A core mission of the NCCHD is to innovate and develop new drugs and medical devices for maternal and child health. The Department of Clinical Research was established to enhance this mission by supporting and managing in-house investigator-initiated and industry-sponsored clinical trials in the development of strategies, design and planning, as well as managing clinical trials in collaboration with other relevant departments and divisions. The department also provides administrative services to the Pediatric Clinical Trials Network, promotes multicenter clinical trials through this network, and governs its Central Review Committee.
OrganizationThe department consists of three divisions: the Division for Clinical Trials, the Division for the Pediatric Clinical Trial Network, and the Division for Clinical Pharmacology and Oral Formulation Development.
Functions and services
Division for Clinical TrialsThis division manages and supports investigator-initiated and industry-sponsored clinical trials in the development of strategies, design, and scheduling, as well as on-site support for clinical trials in collaboration with other departments and divisions. The Clinical Research Coordinators (CRCs) support and manage clinical trials in accordance with Good Clinical Practice and other regulations and guidelines. So far the CRCs mainly provide support to industry-sponsored clinical trials, but once the number of CRCs increases, this will gradually expand to include investigator-sponsored clinical trials.
Division for the Pediatric Clinical Trial NetworkThis division undertakes the role of the administration office for the Steering Committee and the Central Review Committee of the Pediatric Clinical Trials Network, which is affiliated with the Japanese Association of Children’s Hospitals and Related Institutions (JACHRI). The division also serves as the “one-stop shop” for industries by promptly providing information on the feasibility and number of candidates for trials in the network, and advising on the practical aspects of trials in collaboration with other departments and divisions.
Division of Clinical Pharmacology and Oral Formulation DevelopmentThis division is in charge of formulation development and pharmacokinetic/pharmacodynamic evaluation of pediatric drugs. In 2015, a laboratory for pediatric formulation will commence operation and the division will begin developing pediatric oral formulations for clinical trials.