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0:00
Hello. I'm Allan Hackshaw.
Here I'm going to talk about
the ethical and regulatory
principles of clinical trials.
In previous sessions
we talked about
the design and analysis
and how they're conducted,
but the ethical aspects
are quite important.
0:18
In this short session,
I'm going to cover participants'
safety and well-being,
principles of good
clinical practice.
Some of the main
regulations that apply to
almost all countries, what
participant information and
informed consent involves.
0:35
All clinical trials are
experimental studies.
This means that some
or all of people in
a study take or get
something they would
not normally have.
Participants enrol either to
get some direct benefit to
themselves or such that
future people or future
patients can benefit.
They often have
additional tests,
scans, blood tests and
other assessments.
There's a moral and ethical
duty to ensure that they are
not unduly harmed by taking
part in a clinical trial.
1:07
Good Clinical Practice are
international guidelines.
They differ a little bit
between some countries but they
have some core
fundamental properties.
There are different
forms of GCP and
the two most common or
well-known ones are
ICH and the European
Medicines Agency.
Many pharma companies and
some medical device companies,
when they run their
trials, make sure
they comply with these
types of GCP if they
want to get approvals for their
drugs or medical devices.
But even for trials
other than drugs,
it's always good
practice to follow
some of the core
concepts of GCP.
