hey guys ECR G here today we're gonna be talking about what it's like running
trials in Japan hey guys ECR G here today we're gonna be talking
about running clinical trials in Japan now I am no expert at running clinical
trials in Japan but I did learn a few things at that kickoff meeting that I
went to not too long ago about some of the key differences in running clinical
trials in Japan versus even Europe and certainly the United States of America
we're gonna go over a few of them today now I'm not an expert but just for a
quick overview in this video of some key differences that you might encounter if
you're looking at running a clinical trial in Japan or if you know one of
your studies has a Japan component some things you may not have known about
running clinical trials there so one of the things that I learned that's very
key about running clinical trials in Japan is the regulatory authority now in
the USA you have the FDA the federal drug administration the Federal Drug
Administration and they are in charge of approving everything that goes to the
market whether it's a pill a tablet you know any kind of medical device or
anything that's gonna go inside your body they've got to approve it so the
Japanese have a similar organization and theirs is called PMD a for short and so
they have different requirements obviously they have different cultural
requirements they have it's just completely different but it is a
government agency that you must get authority to in order to run the
clinical trial and just similar to how to FDA works the PMD a who works in that
same regard and they are there to ensure the safety
of whatever you're bringing to the market so just off the bat there you
know there's gonna be a key difference because you're working in two different
governments to different parts of the world so there are gonna be some key
differences there working in Japan so the key one that there you have to know
is the PMD a and they have different regulations but all that stuff can be
found online for more information about that so different regulations is one the
second thing you have to keep in mind when running a clinical trial in Japan
is the different cultural boundaries that are in place going to a different
country so obviously there's even different cultures in the United States
you know from the north to the south the South tend to be a little bit warmer
tend to be a little bit slower at things you know there's just a different
culture moving around the country well there's the south east whether it's the
west coast whereas the Northeast there's different
cultures and different way things are done so obviously you know going to a
whole different country there's gonna be different cultures as well so you know
the culture is just different so one of the things you have to keep in mind is
that that's going to play a major role in how your clinical trial is run for
example the Japanese prefer more face-to-face communication so you know
that that's that's a key thing you have to consider you know they really want to
meet face to face they don't really want to talk on the phone too much or do
WebEx they haven't fully embraced that as much they prefer more face-to-face
communication for example for you know just to initiate a site they require
five to seven monitoring visits and that's just how they like to do it
whereas in the USA you can do that in one to two or even Europe you can do it
in one to two so just just something to keep in mind when running clinical trial
in Japan you know and there tend to be a little bit more formal in their
communication as well so you have to keep that in mind that there's gonna be
communication differences between Japan and the rest of the world
you know if you if you know this going in then you're gonna know more what to
expect when running your clinical trial there so those are two key differences
and the third key difference to running a clinical trial in Japan is because
there are so many differences between Japan and the rest of the world Japan is
really gonna require its own team to operate or a team very experienced in
dealing with Japan so usually at the CRO level at least there is a US team then
there's a Europe team but now there's gonna be a Japan team if you're gonna be
operating in Japan just because there's so much red tape to go through there's
just so much different so many differences going on you're really gonna
need somebody who's well versed in how to deal with Japan and running clinical
trials there in order to operate in Japan so those are three things to keep
in mind just three quick things that I noticed overarching concepts there with
running clinical trials in Japan I thought the overall process was very
interesting and you know it's so important the key differences there that
we had our own separate meeting dealing with Japan alone you know we don't do
that with other countries the EU and all the countries that you operate there is
treated pretty much as the same even though there's gonna be different
countries but Japan was treated as treated as one and they have their own
set of rules and regulations there and it's very important to keep to keep in
mind that there are gonna be differences between Japan and the rest of the world
and the USA there are some similarities but there are gonna be differences as
well so just want to share with you guys a little bit that I learned I will be
helping run out we're in a clinical trial in Japan in the future so maybe
more things to come about Japan in the future if not I should be a good start
to just understand at the basic level that there are key differences between
Japan and the rest of the world so if you like this video please like it share
with all your friends share it with anybody that you think may benefit from
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channel love getting feedback from you guys as always email us at elite
clinical group at gmail.com and stay tuned for another video soon bye