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0:00
Hello. I'm Allan Hackshaw.
I'm going to give a
short overview of
assessing the safety and
harms of clinical trials.
0:11
In this short session,
we're going to look
at how we define
safety and harm, how
they're measured,
a bit on how they're
interpreted,
and it's particularly
important how they're
monitored in clinical trials.
This is what matters
to patients,
all participants when
they decide to go into a study.
0:28
Hardly any interventions
have no harms at all,
and the public, patients,
and health professionals need
to have some idea of what
the harms are to see whether
the efficacy benefits
outweigh the harms.
New treatments might
increase survival from say
6-8 months and that
extra two months might
seem worthwhile,
but, if many people have
many side effects during
those two extra months,
that survival benefit
might not be so obvious;
and many drugs
have side effects.
Even something like an
exercise routine as
a new intervention for weight
loss might seem harmless,
but if this involves
very rigorous intensity
and there are some older people
who might not be very fit,
some could suffer
issues by having
that heavy exercise routine;
therefore, all safety
and harms should
be assessed properly
in a clinical trial.
1:25
There are various words
used for safety and harms.
Other words are: side effects,
adverse events, and toxicities.
They're all used interchangeably
and they're there to
reflect any disorder or
symptom that affects
a person's health,
function, or well-being
and adversely affects
any of those.
They could be physical measures
that people can feel
or somebody can see
occurring in somebody or
they could be adverse events
that are seen in blood or
urine tests or scan images.
We often separate harms from
efficacy even though sometimes
they might look related.
An adverse event is not usually
the natural consequence of
the disorder of interest.
If we're looking to prevent
heart disease in a
trial using a new drug,
if somebody has a heart
attack or stroke,
we don't usually call
that an adverse event.
If it is really an adverse event
we count that as
part of efficacy.
Whereas, other events
like diarrhea,
or headaches are not related
to the disorder of
interest directly,
they would be labeled harms
and adverse events
or toxicities.
