Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis
- PMID: 27453832
- PMCID: PMC4936074
- DOI: 10.4103/2229-3485.184823
Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis
Abstract
During the conduct of clinical trials, it is not uncommon to have protocol violations or inability to assess outcomes. This article in our series on common pitfalls in statistical analysis explains the complexities of analyzing results from such trials and highlights the importance of "intention-to-treat" analysis.
Keywords: Bias; biostatistics; intention-to-treat analysis.
References
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- Fisher LD, Dixon DO, Herson J, Frankowski RK, Hearron MS, Peace KE. Intention to treat in clinical trials. In: Peace KE, editor. Statistical Issues in Drug Research and Development. New York: Marcel Dekker; 1990. pp. 331–50.
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- Perkin MR, Logan K, Tseng A, Raji B, Ayis S, Peacock J, et al. Randomized trial of introduction of allergenic foods in breast-fed infants. N Engl J Med. 2016;374:1733–43. - PubMed
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