Trial analysis by treatment allocated or by treatment received? Origins of ‘the intention-to-treat principle’ to reduce allocation bias: Part 2
Abstract
By the late 1950s, the key role played by the Medical Research Council (MRC) in the development of controlled clinical trials – and of Hill’s leadership specifically – had become widely recognised. The example that had been set by the MRC during the 1950s led the Council for International Organizations of Medical Sciences (CIOMS) to invite Hill to plan and chair a conference on ‘Controlled Clinical Trials’. The conference was convened under the joint auspices of the UN Educational, Scientific and Cultural Organisation (UNESCO) and the World Health Organization (WHO) ‘to discuss the principles, organization and scope of “controlled clinical trials”, which must be carried out if new methods or preparations used for the treatment of disease are to be accurately assessed clinically
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An intention-to-treat analysis population is widely recommended as the preferred analysis population.
“An intention-to-treat analysis population is defined by the inclusion of outcome data from all participants in their originally allocated group—this is widely recommended as the preferred analysis population.360 419 420”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [420]
Cites
What is meant by intention to treat analysis? Survey of published randomised controlled trials
Hollis, S., & Campbell, F. (1999) · BMJ · doi:10.1136/bmj.319.7211.670 · Cited by 2,160 · see citing works
Intention-to-treat concept: A review
Gupta, S. (2011) · Perspectives in Clinical Research · doi:10.4103/2229-3485.83221 · Cited by 1,921 · see citing works
Understanding the Intention-to-treat Principle in Randomized Controlled Trials
McCoy, E. (2017) · Western Journal of Emergency Medicine · doi:10.5811/westjem.2017.8.35985 · Cited by 767 · see citing works
Intention-to-Treat Analysis: Implications for Quantitative and Qualitative Research
NEWELL, D. J. (1992) · International Journal of Epidemiology · doi:10.1093/ije/21.5.837 · Cited by 715 · see citing works
Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis
Fergusson, D., Aaron, S. D., Guyatt, G., & Hébert, P. (2002) · BMJ · doi:10.1136/bmj.325.7365.652 · Cited by 708 · see citing works
Intention-to-treat analysis and the goals of clinical trials*
Sheiner, L. B., & Rubin, D. B. (1995) · Clinical Pharmacology & Therapeutics · doi:10.1016/0009-9236(95)90260-0 · Cited by 315 · see citing works
Including all individuals is not enough: lessons for intention-to-treat analysis
White, I., Carpenter, J., & Horton, N. (2012) · Clinical Trials · doi:10.1177/1740774512450098 · Cited by 299 · see citing works
Analysis of clinical trials by treatment actually received: Is it really an option?
Lee, Y. J., Ellenberg, J. H., Hirtz, D. G., & Nelson, K. B. (1991) · Statistics in Medicine · doi:10.1002/sim.4780101011 · Cited by 283 · see citing works
Modified intention to treat reporting in randomised controlled trials: systematic review
Abraha, I., & Montedori, A. (2010) · BMJ · doi:10.1136/bmj.c2697 · Cited by 257 · see citing works
Abraha, I., Cherubini, A., Cozzolino, F., De Florio, R., Luchetta, M. L., Rimland, J. M., Folletti, I., Marchesi, M., Germani, A., Orso, M., et al. (2015) · BMJ · doi:10.1136/bmj.h2445 · Cited by 165 · see citing works
Statistical reviewing for medical journals
Altman, D. G. (1998) · Statistics in Medicine · doi:10.1002/(sici)1097-0258(19981215)17:23 · Cited by 157 · see citing works
Intention-to-treat. What is the question?
Feinman, R. D. (2009) · Nutrition & Metabolism · doi:10.1186/1743-7075-6-1 · Cited by 134 · see citing works
Montedori, A., Bonacini, I., Casazza, G., Luchetta, M. L., Duca, P., Cozzolino, F., & Abraha, I. (2011) · Trials · doi:10.1186/1745-6215-12-58 · Cited by 112 · see citing works
Principles of Medical Statistics
Schilling, R. (1955) · Occupational and Environmental Medicine · doi:10.1136/oem.12.3.262-a · Cited by 80 · see citing works
Intention to treat analysis is related to methodological quality
Ruiz‐Canela, M. (2000) · BMJ · doi:10.1136/bmj.320.7240.1007 · Cited by 76 · see citing works
The role of intention to treat in analysis of noninferiority studies
Wiens, B. L., & Zhao, W. (2007) · Clinical Trials · doi:10.1177/1740774507079443 · Cited by 72 · see citing works
Newcombe, R. G. (1988) · Statistics in Medicine · doi:10.1002/sim.4780071111 · Cited by 64 · see citing works
Martin, K. W., & Ernst, E. (1961) · Postgraduate Medical Journal · doi:10.1136/pgmj.37.424.111 · Cited by 25 · see citing works
Alfred Watson Memorial Lecture: The Statistician in Medicine
Hill, A. B. (1962) · Journal of the Institute of Actuaries · doi:10.1017/s0020268100014980 · Cited by 23 · see citing works
Statistical Issues in Drug Development
Chowdhry, A. K. (2022) · Journal of the Royal Statistical Society Series A (Statistics in Society) · doi:10.1111/rssa.12814 · Cited by 10 · see citing works
Furberg, C. D. (2010) · Journal of the Royal Society of Medicine · doi:10.1258/jrsm.2009.09k074 · Cited by 5 · see citing works
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SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
Self-citation
- Authors
- Chalmers, I., Matthews, R., Glasziou, P., Boutron, I., & Armitage, P.
- Affiliations
- University of Oxford (GB)
- Aston University (GB)
- Bond University (AU)
- Inserm (FR)
- 2 Reading Road, Wallingford OX10 9DP, UK
- Corresponding author
- Chalmers, I
- Venue
- Journal of the Royal Society of Medicine
- Publisher
- SAGE Publications
- Published
- 2023-11
- Volume
- 116
- Issue
- 11
- Pages
- 386-394
- ISSN
- 0141-0768 (ISSN-L)
- 1758-1095
- OpenAlex
- W4388761956
- Cited by
- 9
- References
- 21
- Citations by year
- 2026: 1 · 2025: 6 · 2024: 1 · 2023: 1
- FWCI
- 1.83
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of the Royal Society of Medicine (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Bond University Research Portal (Bond University) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Historical Medical Research and Treatments
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- allocation bias, Medical Research Council, Austin Bradford Hill, CIOMS, history of clinical trials
- MeSH terms
- Humans, Research Design, Bias, Treatment Outcome, Intention, Intention to Treat Analysis
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