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0:00
Hello, I'm Allan Hackshaw,
and I'm going to give
a short overview
of how clinical
trials are conducted.
Previous sessions looked at
the scientific features of
trials in terms of how they
are designed and analyzed,
and this session is
going to be about how
trials are implemented
and set up.
0:22
I'm going to give an overview of
the main steps in
setting up a new trial
and this covers all
types of interventions,
some of the key procedures
that need to be in place,
and who has ultimate oversight
of a clinical trial.
0:37
On this slide is a
simple diagram showing
the key features or
key aspects of a trial
going from trial setup,
to trial conduct,
to what happens at
the end of a trial,
because ultimately you
publish it and make
the results available
to the general public.
I'm going to go
through each of these
sections in turn briefly.
1:03
Setting up a new trial is
obviously a major step.
It'll require several
health professionals
with different
levels of expertise,
and modern trials involve
multiple documentation
procedures that
often is off-putting and
daunting to many investigators,
particularly new ones,
but unfortunately, this
is how many are done.
For interventions
that involve drugs or
medicinal products and
some medical devices,
there are additional
national regulations
and laws that need
to be complied with.
1:37
What do we need to do
when we set up a
new clinical trial?
An important step
is establishing
a small working group that's
going to be health or
clinical professionals,
statistician, and other
relevant expertise
as per the study in question
such as a surgeon,
pathologist, health economist.
We should always
involve patients or
public representatives
now in trials so
they understand what the study
is going to be because
they often have
a good insight into a new study
and why it needs to be done
and an experienced study
coordinator or manager.
And they will take an
outline of a study
and expand it into a
fuller description.
These people will then form
what may be a grant application,
whether it's to a
healthcare provider,
a public sector organization,
a charitable organization, or
a commercial company such as
a pharmaceutical company.
Grant applications require
great skill to write.
Not many are successful
and it requires a
small working group
to go through the
study very carefully,
why it's being done,
write it up in a
way that others can
understand to justify funding.
