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ERDO - a framework to select an appropriate randomization procedure for clinical trials
- Source :
- BMC medical research methodology 17(1), 159 (2017). doi:10.1186/s12874-017-0428-z, BMC Medical Research Methodology, BMC Medical Research Methodology, Vol 17, Iss 1, Pp 1-12 (2017)
- Publication Year :
- 2017
- Publisher :
- Zenodo, 2017.
-
Abstract
- Background Randomization is considered to be a key feature to protect against bias in randomized clinical trials. Randomization induces comparability with respect to known and unknown covariates, mitigates selection bias, and provides a basis for inference. Although various randomization procedures have been proposed, no single procedure performs uniformly best. In the design phase of a clinical trial, the scientist has to decide which randomization procedure to use, taking into account the practical setting of the trial with respect to the potential of bias. Less emphasis has been placed on this important design decision than on analysis, and less support has been available to guide the scientist in making this decision. Methods We propose a framework that weights the properties of the randomization procedure with respect to practical needs of the research question to be answered by the clinical trial. In particular, the framework assesses the impact of chronological and selection bias on the probability of a type I error. The framework is applied to a case study with a 2-arm parallel group, single center randomized clinical trial with continuous endpoint, with no-interim analysis, 1:1 allocation and no adaptation in the randomization process. Results In so doing, we derive scientific arguments for the selection of an appropriate randomization procedure and develop a template which is illustrated in parallel by a case study. Possible extensions are discussed. Conclusion The proposed ERDO framework guides the investigator through a template for the choice of a randomization procedure, and provides easy to use tools for the assessment. The barriers for the thorough reporting and assessment of randomization procedures could be further reduced in the future when regulators and pharmaceutical companies employ similar, standardized frameworks for the choice of a randomization procedure. Electronic supplementary material The online version of this article (doi:10.1186/s12874-017-0428-z) contains supplementary material, which is available to authorized users.
- Subjects :
- Restricted randomization
Randomization
Design
Epidemiology
Computer science
media_common.quotation_subject
Inference
Health Informatics
Machine learning
computer.software_genre
01 natural sciences
law.invention
010104 statistics & probability
03 medical and health sciences
Random Allocation
0302 clinical medicine
Randomized controlled trial
Type I error probability
law
Humans
030212 general & internal medicine
Chronological bias
0101 mathematics
Selection (genetic algorithm)
media_common
Randomized Controlled Trials as Topic
Selection bias
lcsh:R5-920
business.industry
Comparability
3. Good health
Clinical trial
Technical Advance
Artificial intelligence
lcsh:Medicine (General)
business
computer
Algorithms
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- BMC medical research methodology 17(1), 159 (2017). doi:10.1186/s12874-017-0428-z, BMC Medical Research Methodology, BMC Medical Research Methodology, Vol 17, Iss 1, Pp 1-12 (2017)
- Accession number :
- edsair.doi.dedup.....454d9c6a11ed53c7da91d3f8c8acaa2c