Difference between itt and safety populations

[samchat]

Hello, I am a newbie here and needed your help. Can anyone please let me know the difference between "intent to treat" (itt) and safety populations?

I was in the process of flagging some data which I was working on, and got stuck not knowing the difference.

Thanks for your help.

-Sam

[tonic]

Hi Sam,

ITT analysis set and safety analysis set should be defined in the documents of  Statistical Analysis Plan(SAP) or Data Presentation Specifications(DPS).

The definition may varies from different protocols but mainly the same:

Safety: any subject who receive at least 1 dose of study medication.

ITT: be classified according to the assigned treatment group, regardless of the actual treatment received.

Also, Safety is used for safety analysis, like AEs

ITT is often used for efficacy analysis, which is conservative for superiority trial.