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Hello. I'm Allan Hackshaw from
University College London.
I'm going to talk now about
the fundamental design
features of clinical trials.
0:11
Here are the things I'm going
to cover in this short session.
The first four topics
are called PICO.
They're a well-known way
of trying to understand
the four key design attributes
of almost all clinical trials.
In addition, I'm going to
mention randomization,
study size and follow-up,
and data collection.
0:32
First thing we need to
look at is who goes into
a clinical trial and we must
specify who the new intervention
is going to be aimed at.
This could be people in
the general community so they
don't have a disorder of
interest or these are
people who already are
ill with the thing that we
are interested in treating.
What we need is something
called eligibility criteria.
This is a list of attributes
that determines who
goes into a trial and also
who needs to be excluded.
These criteria could be
short or they could be long.
If we have a short criteria,
these results are applicable to
a wider group of
people or patients.
If there are many criteria,
it means the trial
results are generally
applicable to a narrow
homogenous group of people.
There's usually a lot of
discussion of how determined
what the criteria are for
each type of clinical trial.
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Some common inclusion
criteria could be
specific characteristics.
It could be age.
There could be things about
the disease features such as
the early or advanced
disease and some measure of
physical fitness and the ability
to have the trial interventions.
Common exclusion criteria could
be people who already have
existing serious illnesses that
could be made worse by
the new interventions.
We don't want to take
the risk of doing so.
There could be people
who don't understand
the trial and therefore
cannot give informed consent.
I'm going to cover that in
a later session and they
could be people who are
pregnant or those
who are already
receiving the type of
intervention before.
These are vague general inclusion
and exclusion criteria.
In reality, the list is
usually longer than this.
