The path to the execution of explorative clinical researches in National Cerebral and Cardiovascular Center (NCVC)

Abstract

In the Ministry of Health, Labour and Welfare's (MHLW) "5-year plan for activating clinical trials", we have put in place the infrastructure including human resources for supporting not only commercial clinical trials but also those initiated by academic researchers, including clinical research coordinator (CRC) support and consultation for planning clinical trial with biostatistician. We also prepared a data management unit and trained data managers for academic clinical trials. In 2011, the National Cerebral and Cardiovascular Center (NCVC) was selected one of the sites of the MHLW project of structure improvement to execute early phase clinical trials. To clinically develop medical devices invented by the NCVC researchers involved in the project, animal experiments which meet the GLP standards must be finished before the first-in-human clinical trial. We are planning to create the units containing human resources for developing medical devices such as professionals in regulatory affairs, safety tests, and Good Laboratory Practice (GLP) systems. Creation of a smooth pathway from the preclinical to the clinical phases will be key to the efficient development of new medical devices. © 2013 The Pharmaceutical Society of Japan -Review.