We often use different populations (Safety, Efficacy, ITT, Per-Protocol) to generate Clinical Trial Reports, but what are the differences between the populations?
Today we will go over the basics of Intention to Treat and Per-protocol Analysis.
We can estimate the Average Causal Effect of the treatment due to the Randomization process.( Treatment is exchangeable)
- What is the outcome if all patients had been treated compared to all patients had not been treated?
Intent to Treat:Mean in the treated to Mean in the Placebo
Average Casual Effect CE= E[Y(tr)] -E[Y(pl)]= E(Y|Group A)- E(Y|Group B) E[Y(tr)]=E[Y(tr)|A]-E[Y(tr)|B]
Reality: Some subjects did not take the medication.
Per-Protocol: Conly compare the compliers
Thanks 77 for sharing the Havard Catalyst material !