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0:00
Hello, I'm Allan Hackshaw from
University College London.
I'm going to give
a short talk about early
phase clinical trials.
0:10
There's a broad categorization
of clinical trials
and not all interventions
go through all of these.
There's Phase 1,
Phase 2, Phase 3,
and something called Phase
4 or real world data.
Each of these phases aims
to do slightly different
things from each other.
As we move through the phases,
the number of participants
usually gets larger.
I'm going to focus now
on early phase studies.
0:38
This session is going to cover
why early phase trials are done,
what kind of information
they provide,
some major designs and
a couple of examples.
0:50
Early phase trials are done
to look at various things
often new unlicensed drugs
either on their own or
combined with existing therapies
or they could even be
two existing treatments,
but they're going to be
combined for the first time
for a particular
disorder and there may
be uncertainty over
their side effects.
They could also be new forms of
radiotherapy or medical devices.
Occasionally, there
might even be new forms
of surgical procedures.
There may be a new
intervention such as
an exercise regimen,
and we just want
some preliminary information
before launching a larger trial.
That's the ultimate aim of
these early phase studies.
We tend not to want to do
a big trial first until
we've got some evidence
about efficacy and harms.
1:36
Let's have a look at
Phase 1 trials briefly,
in terms of what
information they provide.
They can provide
various aspects about
the pharmacological
properties of
a new drug or existing
drugs combined together.
There are two main areas.
One is how the drug
affects the body.
The other one is how the
body deals with the drug.
These are called pharmacodynamics
and pharmacokinetics.
They sound very technical and
there are various ways that
we can quantify these.
We also are very
interested in the harms,
the side effects, or toxicities.
We'll want to know
are they minor?
Are they severe?
Do they require hospitalization?
Then we may want to look at
early measures of efficacy.
They may not be very liable by
the way in these small trials,
but we want to look
at them anyway.
These are usually
quick to measure.
