Biostatistics and epidemiology
Randomisation, allocation concealment, blinding and intention-to-treat
What randomisation, allocation concealment and blinding each protect against, how intention-to-treat differs from per-protocol analysis, with a worked NNT example and the RoB 2 domains.
Tier 1Medical sciences concept
Written with AI assistance and fact-checked against the sources below. For exam study, not clinical decisions. How notes are made
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Sources
- CONSORT 2025 statement: updated guideline for reporting randomised trialsBMJ (Hopewell et al., 2025), 2025
- ICH E9 Statistical principles for clinical trials, and E9(R1) addendum on estimands and sensitivity analysisInternational Council for Harmonisation (adopted by the TGA), E9 1998; E9(R1) 2019
- RoB 2: a revised tool for assessing risk of bias in randomised trialsBMJ (Sterne et al., 2019;366:l4898), 2019
- Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trialsJAMA (Schulz et al., 1995;273:408-12)
- Allocation concealment in randomised trials: defending against decipheringLancet (Schulz and Grimes, 2002;359:614-8)
- Cochrane Handbook for Systematic Reviews of Interventions, chapter 8: Assessing risk of bias in a randomized trialCochrane (Higgins et al., version 6.5), 2024
- Last updated
- 14 November 2026
What changed
- 14 November 2026 Personal emails, About story and Australian-style copy