Hi,
Some references:
Ranganathan P, Pramesh CS, Aggarwal R. Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis. Perspect Clin Res. 2016 Jul-Sep;7(3):144-6. doi: 10.4103/2229-3485.184823. PMID: 27453832; PMCID: PMC4936074.
Intention to treat and per protocol analysis in clinical trials
Giovanni Tripepi, Nicholas C. Chesnaye, Friedo W. Dekker, Carmine Zoccali, Kitty J. Jager
2020
https://doi.org/10.1111/nep.13709
BOOK: Randomized Controlled Trials
Carole J. Torgerson, David J. Torgerson, Celia A. Taylor
Book Editor(s):Kathryn E. Newcomer, Harry P. Hatry, Joseph S. Wholey
2015
https://doi.org/10.1002/9781119171386.ch7
safety population - as dosed (even if dosed in wrong treatment arm), only patients included that received at least 1 dose of drug in the study
ITT population - as randomized (even if you did not start treatment or received the wrong treatment, or stopped treatment), all patients included that were randomized
Per protocol population - subset of ITT population that had no major protocol deviations (needs top be defined, e.g. by dosing compliance, met all IC/EC, completed double-blind treatmnent period or such things), patients excluded from PP population to be determined at blinded data review meeting before unblinding
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