- [Voiceover] Hey guys, this is Dr. Joel with MedImmersion.
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Okay, let's get started.
This video is on the clinical trial.
And right off the bat,
I need to emphasize that really
only phases one, two, and three
are the highest yield for you to understand.
However, for completeness sake,
I just wanna hit briefly on phase zero and phase four.
SO starting with phase zero of a clinical trial.
This is basically the very initial tests
of pharmacodynamics and pharmacokinetics.
The researchers are giving very,
very small doses of their new drug or therapy
to a small group of healthy people, or possibly animals.
It's not really important to remember
the number of subjects in the phases of the trial,
but just as long as you understand
that the number of subjects gets
larger and larger through each phase.
Basically, in phase zero,
they're just looking for the very earliest data
on how the drug works on the body,
and how the body works on the drug.
Next into phase one.
Phase one is more or further
testing into the safety of the drug,
and the real question they're
asking here is is this drug safe?
So again, a very small group of healthy subjects,
and by the time you get to phase one,
you are pretty much always testing on human beings.
But again, a very small dosage,
and a very small group of people
who are healthy, they don't have any disease,
we're just again, expounding the knowledge
on what these side effects could be.
Phase two is where we start working with
larger groups of people who actually have a disease,
the disease we're trying to study,
and the question for this phase is does it work?
Does the drug do what we thought that
it was gonna do in people with the disease?
Side effects are continually monitored.
In fact, side effects are never not monitored,
through phase two, three, four,
for the entity of a drug's life,
we're constantly watching the
side effects and recording those.
Phase three is the final step before they finally
decide if they can or can't sell the drug.
They're confirming it actually works.
They're confirming that compared
to other treatments or other drugs
it works at least as good, if not better.
If it is not as good as other similar drugs on the market,
then they would have to evaluate
from a business and marketing point of view,
if it's even worth the money that
they're investing to continue with this drug.
Lastly, phase four is done when
the drug is out in the market,
it's being used by actual patients,
and you can think of it as a post market surveillance.
Basically, we're continuing to watch for adverse effects,
for how well the drugs are working,
and continuing to develop protocol
on how to use it better and better.
Thanks for watching, guys.
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