IV-3. “Preliminary Study for Multi-regional Clinical Research and Clincial Trials on Neurological Diseases in Asia” (H28 FY2016)


  • Project Leader:Banno Haruhiko (Massachusetts General Hospital, Neurological Clinical Research Institute)
  • Collaborators:Hasegawa Yoshinori (Nagoya University, Center for Advanced Medicine and Clinical Research)
  •                              Kasuya Hideki (Nagoya University, Graduate School of Medicine Office of International Affairs)
  •                              Toyama Ayako (Kyoto University, Center for Southeast Asian Studies)
  •                              Nakanishi Yoshihiro (Kyoto University, Center for Southeast Asian Studies)

Outline of Research

We will develop an action plan for multi-regional clinical studies and clinical trials on neurological diseases between Southeast Asian countries and Japan. For this purpose, Thai and Japanese researchers will identify effective collaboration methods. Our future goals include building an international study consortium. Based on valuable input from researchers at the Center for Southeast Asian Studies (CSEAS) we will address the need for both field research in Southeast Asian countries and collaboration framework development in Japan. Through this preliminary study, we will identify obstacles and create a roadmap for future collaboration in the field of neurological diseases.

Description

A gap in time between the approval of a drug of foreign origin in other countries and in Japan, known as the “drug lag” problem, prevents Japanese patients from accessing up-to-date pharmaceuticals. At the same time, Asian clinical studies are becoming increasingly important with the recognition of pharmacogenetic differences between Asians and Caucasians. Thus an Asian consortium for clinical studies and clinical trials will be indispensable in the future.

As the case of amyotrophic lateral sclerosis (ALS) demonstrates, there are many neurological diseases that are rare in number but fatal. Therapy development for these diseases is urgently needed. Multi-regional research, including gene analyses from multiple ethnic groups and internationalclinical trials recruiting many patients from many countries will facilitate the investigation of disease mechanisms and contribute to finding cures for these untreatable diseases.

 


Clinical research center at Chulalongkorn University with state-of-the-art lab equipment

Pharmacokinetics center at Chulalongkorn University