Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis
Priya Ranganathan, C S Pramesh, Rakesh Aggarwal, Priya Ranganathan, C S Pramesh, Rakesh Aggarwal
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
- Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011;2:109–12.
- 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.
- Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7:e1000251.
- Schumi J, Wittes JT. Through the looking glass: Understanding non-inferiority. Trials. 2011;12:106.
- 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.
Source: PubMed