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0:00
Hello everyone,
my name is Oleksandr Sverdlov,
and I'm a Senior Director of
Biostatistics at Novartis.
Today, my presentation is on
Randomization in Clinical Trials:
Time for Fresh Consideration?
0:17
Here's the outline
of my presentation.
I'll start with some background
on randomization in
clinical trials.
Then I'll describe the
balance-randomness tradeoff.
Then I'll talk about
validity and efficiency
considerations.
After that, I'll describe
the importance of
covariate adjustment
in the context of
randomized clinical trials.
Finally, some additional
important topics
on randomization.
0:47
Here's the background on
randomization in
clinical trials.
0:53
Some historical perspective
on randomization.
We are really standing on
the giant's shoulders.
The work of Ronald Fisher,
"The Design of Experiments",
Sir Bradford Hill's work,
and Jerome Cornfield's work,
"Principles of Research",
they all form an
important basis for
the theoretical approach
on randomization method.
1:19
Why is randomization
important in clinical trials?
There are three main reasons.
The first one is that
randomization helps
mitigate selection
bias in the design.
Especially when the study
is an open-label study.
Second, randomization promotes
the similarity of
treatment groups with
respect to known and
unknown confounders.
Third, it contributes
to the validity of
statistical estimators
and tests, and in fact,
it can form the basis for
re-randomization tests.
What are other important
considerations
