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0:00
Hello, I'm Allan Hackshaw,
and I'm going to
give a short talk
about late phase
clinical trials.
0:09
Here is that broad
categorization of
clinical trials again
from Phase 1 to Phase 4,
and I'm going to
focus on Phase 3.
These give us definitive
assessments of
efficacy and safety,
and they are meant to
be practice-changing.
0:27
In this short session,
I'm going to outline why
late phase trials are done,
what information they
provide and some examples.
0:37
When we do late phase trials,
because they are usually large,
we already have some information
about their efficacy and safety.
There's a whole variety
of interventions
that can be evaluated
in Phase 3.
We can use unlicensed drugs
on their own or combined
with other therapies.
There could be new
forms of surgery,
radiotherapy or medical devices.
As I said before,
the main aim is to
change clinical or public
health practice to
allow everyone who
can benefit from
the new intervention to do so
if they have access to it.
1:15
What information can
Phase 3 trials provide?
Even the early phase trials that
I covered in the
previous section provide
this kind of information,
but late phase Phase 3
trials must always
provide this information.
We're looking at
efficacy, safety,
health related quality
of life and adherence.
Even though they look separate,
one can affect the other.
Somebody who has
lots of side effects
to a new treatment
could make them stop
the treatment early
so they don't
get the full amount of
benefit or efficacy.
When we look at these four
things on the screen,
we need to consider the
benefit and harm balance.
In addition, we can also look at
health economics or
cost-effectiveness.
The ultimate goal
is to make sure
that on balance there
are going to be
more benefits to patients
or participants than harms.
