~ The Current Status of “Multi-Regional Clinical Trials (MRCT)” ~
     What we should do now?

Hi there, this is Global Clinical Research Support Office, Department of Medical Innovation.
On June 14th, we invited the lecturer named Mr. Hirofumi HAMANAKA from the Vras Research Japan, a Clinical Research Organization (CRO) headquarter in Malaysia that leads the Asian market collaborating with Singapore. He has been implementing and supporting a lot of Multi-Regional Clinical Trials (MRCT) in Asia as well as United Status of America.

Even though we had the seminar in the different time schedule from the ordinary time, thankfully a lots of people were participated.

His talk focused on the current situation of “Multi-Regional Clinical Trials (MRCT)” based on his actual past fulfilling academia experiences.

As the current status of MRCT, China has been promoting globalization since the late 2015. China is willing to play a central role of conducting global clinical trials not only in Asia but also worldwide. As a result, it makes China to proceed forward rapidly in terms of developing and maintaining the pharmaceutical regulations.

There are huge differences in the process of decision making with regard to the research and development in medical field between Japan and other countries, he said. It appears to take longer time to make decisions during discussion in Japan, because there is a strong tendency not to go to next step until each task reaches perfection. On the other hand, in other countries, it seems that when an issue or problem arises, it resolves on the spot, that is to say, things seems to be proceeded without any postpone.

He gave us a message that we should take a leadership with taking into consideration of a difference in resolving issues between countries, when we conduct and plan global clinical trials. Besides, he emphasized that we need to conduct global clinical trials with keeping a mind of Japan’s unique creativity.

We had a couple of inquiries after the lecture as usual, and someone asked:
“How can academia (we) succeed in the world?”
He answered quite interestingly and strongly, “You should know that to be successful in the world, it’s not the neither matter of fund nor the issue of different regulations. This is all about how soon you get the positive, strong, prompt and adequate DECISION from your BOSS!!!!” He left the very impressive phrase to us.

He concluded that in order Japan to take initiatives among the globalization of clinical trials, we need to recognize that the active response and decision are the most important requirements for us to conduct the MRCT.

Our 5th seminar will be held on the July 27th (Thurs.). We will welcome Dr. Tsuyoshi KOMATANI, PhD, planning to talk about ‘Intellectual Property' of the medical academia life and - What researchers, 'Principal role' need to be careful in laboratory and clinical to avoid ruining valuable property ".

Since we are accepting advance questions from anyone who wishes to attend the next seminar, please do not hesitate to contact us and a variety of questions are welcome.

【Contact Email】seminar@dmi.med.osaka-u.ac.jp

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