Clinical Research and Evaluation of the Medical Therapeutics
Overview
Academic research organizations (AROs) are ideally positioned to conduct collaborative clinical trials worldwide. Particularly regarding orphan diseases, rare cancer, and pediatric diseases that are difficult for pharmaceutical companies to address, it may be possible for academia to take the initiative in conducting clinical trials and solving various issues.
Clinical Research and Evaluation of the Medical Therapeutics was established as the counterpart of Clinical Research Center at Chiba University hospital in 2013 to educate graduate school students.
Professor:
Hideki HANAOKA MD., PhD.
TEL: +81-43-222-7171
e-mail: hanaoka.hideki●faculty.chiba-u.jp
URL: https://www.ho.chiba-u.ac.jp/crc/english/index.html
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Research & Education
The Chiba University Clinical Research Center (CCRC) was established in 2000. We are currently promoting ARO human development, organizational development, and clinical trials while using the Duke Clinical Research Institute (DCRI) as a model and exploring the development of AROs that are suitable for Japan. In addition to building a network of clinical research institutions in Japan, we are expanding the scope of our activities in cooperation with overseas clinical research institutions. One of them, the Region Asia Clinical Trial Association (REACTA), aims to build an ARO collaborative model in Asia.
CCRC-ARO at Chiba University was established in 2007, and its staff has grown from seven members to about 100. Our approach is to actively plan and execute clinical trials on our own, and we model ourselves after DCRI’s ARO. Our mission is to improve patient care with scientific leadership and high ethical standard through innovative and collaborative clinical research.
Recent Publications
We received approval from PMDA on February 21, 2020 to expand the indications for cyclosporine as a new treatment for Kawasaki disease. Kawasaki disease is an acute vasculitis of unknown cause that predominantly affects infants and young children, causes coronary artery abnormalities such as aneurysms and dilations in about 25 percent of untreated patients, and is the leading cause of acquired heart disease in children in high-income countries.
The KAICA trial (a Kawasaki disease study to assess the efficacy of Immunoglobulin plus Cyclosporin A (CsA)) was a comparative randomized study that enrolled 200 infants. The results of the study were published in Lancet in 2019, and we obtained approval from PMDA for the additional indication for CsA as severe Kawasaki disease. In addition to our ARO activities, collaboration between investigators, regulators, companies, and funding agencies is essential for conducting IRT trials. (https://globalforum.diaglobal.org/issue/april-2020/investigator-initiated-registry-trials-in-japan-and-the-reacta-network-in-asia/)