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The Basics
Definition
RCT
The
Rx group 1
Eligible patients
Rx group 2
?Why Randomize
We
trial
To ensure that difference in groups is
because of the Rx
For this you need comparable groups at the
start of trial
Purpose of randomization is to make the
treatment groups comparable
Value of randomization
it
RCT
the
Prospective
Controlled
unbiased
Non-randomized studies II
non-randomized studies
Difficult
Randomization
must be unpredictable
Random allocation
all
We need randomization
to
be done properly
to ensure similar numbers in groups
To combine with stratification -in large trialsto ensure comparability
Pseudo-randomisation
Alternating
record number
Date of birth
Geographical distribution
True randomization
Blinding
The
Types of RCTs
RCTs according
Open trials
Single blind trials
Double blind trials
Triple blind trials
Blinding is difficult
Having
Parallel trials
Crossover trials
Trials
Follow up
During
the trial
After
Disadvantages of RCTs
Interim Analysis
Done
in large RCTs
To explore the results after recruiting of half
of the participants
If marked difference is recognized , then trial
should be stopped
Examples: WHI trial
Breech Trial
up a protocol
Recruit your patients
Randomize (try to be blind)
Follow up
Analyze your data
Publish
RCTs
The gold standard for therapeutic research
Basis for Meta-analysis
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