hey guys ECR G here back with another video today we're gonna be talking about
the phases of clinical trials hey guys ECR G here back with another video we've
got a really good one for you guys today this is a more clinical research
specific video so if you watch this channel and not really interested in
clinical research you can go ahead and just skip this video and watch one of
the other videos instead but today we're talking about the phases of clinical
trials now a lot of people may have heard about clinical trials they may
have learned about the phases of clinical trials in biology and thought
it might have been confusing or not but we're gonna go over it today nice and
easy for you to understand and for those of you who are trying to get into the
clinical research space this is helpful to know for your interviews that I'm
sure are coming up and so a lot of people think there are three phases of
clinical trials and that's a that's a good thought but they're actually more
than just three that you may know of so there's in addition to the phase 1 phase
2 phase 3 there's what's called a phase 4 which can happen after the drug is
already on the market and there's also a preclinical phase which is before phase
1 so all in all there are about five phases of clinical research
if you want to be complete there but of course the phase one two and three are
the main ones that's where most of the money and intensive energy expenditure
is is done and those are the three main ones so the first one we're going to
talk about is preclinical because we want to be complete here and the goal of
the preclinical phase is to test the to test an initial idea to see if it has
any effect so they may have a compound or something that they're thinking of
that they're working on and they just want to test it to see if it does
anything and so the preclinical phase is
different from all the rest because this is where they test it in animals so this
could be in rats mice any other animals that they may test it in so that's the
preclinical phase and this is before phase one and there they're just testing
the compound that they may have to see if it has any effect so that's the
preclinical then there's phase one and the goal of phase one is to find the
safest dosed to find the faith's safest dose and to find the most effective way
to deliver the drug and start thinking about the side effects so this is done
in a small cohort of healthy patients this does not have the the disease that
they're interested in looking at these are healthy patients and they just want
to find out about the side effects because though the smallest dose that
they find that has side effects will be the maximum dose used in the remainder
of the trial so that's interesting so that's that's phase one usually you know
just gonna have a few maybe ten or so healthy patients that do not have the
disease okay so then there is phase two of the clinical trial which was gonna
build on the results of Phase one like I said so the smallest dose that causes
side effects in Phase one will be the maximum dose used in Phase two and
there's gonna see how well the treatment works and there this is the this is the
first time that patients with the actual disease are introduced to the drug so
once again this is gonna be small probably probably bigger than phase one
in the terms of number of patients but it's gonna just be small just to see how
it is and if it's if the treatment is effective and it is safe then they're
gonna move on to Phase three and the key thing to know here is that this is the
first time the drug is introduced the drug or medical device or whatever it is
they're testing is introduced to patients with the affected disease
so if pal things go well in Phase two they're gonna move on to Phase three and
this is the largest group this is where the largest amount of money is spent
they can have hundreds sometimes thousands of patients and you know this
is where they do all the randomization and stuff like that I mean this is these
are huge a lot of money is spent on these phase three clinical trials and
the goal here is to really see if the new treatment is better than the current
standard of care so and and then this this is like the pretty much the final
part there's a phase four but this is most important and then they're gonna
submit the drug to the FDA if everything goes well in phase 3 phase 4 so I mean
obviously this is the huge part this could take years to you know run a phase
3 it's large-scale takes much longer than the phase 2 because you're dealing
with so many more patients you have to recruit all these patients etcetera etc
we're in phase 2 those are just healthy patients you know you could find those
anywhere so it's not gonna take as long to go through so that's that and then
there's a phase 4 which which the main goal is just to analyze how you know
it's being used on an everyday basis and the patients to see if it can remain on
the market so they take that data and they run a phase 4 study with it and
really understand if it's better or equal to the current standard of care
what the side effects are because sometimes you don't see the side effects
or all of the side effects and see how it's impacting people until it's already
on the market but they're continuing to study it and everyday you know people
and you know they're just making sure that everything is ok before they can
before it completes the face for completely
so that's all the phases right there so preclinical phase 1 phase 2 phase 3 and
then of course phase 4 and those are the phases of clinical trials guide not nice
nice and easy not as complicated as you might have thought I mentioned some of
the key distinctions between each of the phases so that's it in a nutshell guys
and if you like this video go ahead and like it if you want to see any more
clinical research related videos comment those down below you can email us at
elite clinical group at gmail.com and you know that's pretty much it for
today's video guys I already hit the red subscribe button take care