Trial reportBMC medical research methodology2021
A roadmap to using randomization in clinical trials.
Trial report in BMC medical research methodology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 59 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparing Decision on Match of Expectations and Aesthetics Using a Conventional Versus a Cloud-based Healthcare Platform Approach in Breast Cancer Patients Proposed for Locoregional Treatment: A Prospective Randomized Trial
Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction in the City of Sanandaj-Iran in 1402: a Double-blinded Clinical Trial Study
Who cites it
59 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The effects of hot-water immersion on cardiovascular and cardiorespiratory health of healthy adults: A systematic review and meta-analysis.Physiological reports · 2026Pooled it
- The Locus-of-Hope Enhancement Program for Filipino Community Health Workers' Hope and Well-Being: A Parallel Randomized Alternative-Treatments Study.Journal of community psychology · 2026Trial
- Protocol of the randomized double blind sham controlled AddVNS study of transcutaneous vagus nerve stimulation mechanisms in depression.Scientific reports · 2026Trial
- Rapid, effective, and affordable randomisation for emergency neonatal research in a low-resource setting: a feasibility randomised controlled trial.BMC medical research methodology · 2026Trial
- Mobile Intervention for Increasing COVID-19 Testing in K-12 Schools Serving Disadvantaged Communities: Randomized Controlled Trial of SCALE-UP Counts.Journal of medical Internet research · 2025Trial
- Efficacy and cost-effectiveness of extended nursing roles in dementia care: Results of the cluster-randomized trial InDePendent.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Trial
- Effectiveness of a Mobile Health System on Compliance With 2-Year Living Kidney Donor Follow-Up in the United States.Clinical transplantation · 2025Trial
- Transcranial direct current stimulation associated with physical exercise can help smokers to quit smoking: a randomized controlled trial.Scientific reports · 2025Trial
- Evaluation of the Effectiveness of a Group CBT-Based Intervention Aiming to Reduce Self-Stigma and Improve Recovery-Related Outcomes in People with Severe Mental Disorders: Randomised Controlled Trial.The Psychiatric quarterly · 2024Trial
- Selecting a randomization method for a multi-center clinical trial with stochastic recruitment considerations.BMC medical research methodology · 2024Trial
- Effect of couple-based health education on male-partners knowledge and attitude towards maternity waiting homes in rural Ethiopia: a cluster-randomized trial.Scientific reports · 2023Trial
- Effect of need-based care on behavioural and psychological symptoms in residents with dementia and formal caregivers' distress in nursing homes: a three-arm cluster randomized controlled trial.European geriatric medicine · 2023Trial
- Novel clinical trial design and analytic methods to tackle challenges in therapeutic development in rare diseases.Annals of translational medicine · 2022Trial
- The effectiveness of a cognitive behavioural therapy for insomnia based intervention to improve sleep quality in nursing home residents, a cluster randomised controlled trial.European geriatric medicine · 2026Article
- Reducing selection bias risk to enhance RCT validity: sandwich mixed randomization outperforms permuted block design.BMC medical research methodology · 2026Article
- A Transparent, Simple, Audit-Oriented Python-Based Binary Allocation Prototype for Clinical Research.Cureus · 2026Article
- A novel real-world data methodology for lymphoma outcome classification: the real-world Lugano study.Journal of comparative effectiveness research · 2026Article
- Real World Evidence Versus Randomised Controlled Trials: Is the Future of Nutritional Sciences Research in Electronic Health Records?Nutrition bulletin · 2026Review
- Clinical Trial Simulation: Planning With the OCTAVE Framework, Implementation and Validation Principles.Statistics in medicine · 2026Article
- Validity of the PortionSize App for Assessing Children's Dietary Intake: Results From a Pilot Study Conducted in Controlled and Free-Living Settings.Pediatric obesity · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRandomization is the foundation of any clinical trial involving treatment comparison. It helps mitigate selection bias, promotes similarity of treatment groups with respect to important known and unknown confounders, and contributes to the validity of statistical tests. Various restricted randomization procedures with different probabilistic structures and different statistical properties are available. The goal of this paper is to present a systematic roadmap for the choice and application of a restricted randomization procedure in a clinical trial.
methodsWe survey available restricted randomization procedures for sequential allocation of subjects in a randomized, comparative, parallel group clinical trial with equal (1:1) allocation. We explore statistical properties of these procedures, including balance/randomness tradeoff, type I error rate and power. We perform head-to-head comparisons of different procedures through simulation under various experimental scenarios, including cases when common model assumptions are violated. We also provide some real-life clinical trial examples to illustrate the thinking process for selecting a randomization procedure for implementation in practice.
resultsRestricted randomization procedures targeting 1:1 allocation vary in the degree of balance/randomness they induce, and more importantly, they vary in terms of validity and efficiency of statistical inference when common model assumptions are violated (e.g. when outcomes are affected by a linear time trend; measurement error distribution is misspecified; or selection bias is introduced in the experiment). Some procedures are more robust than others. Covariate-adjusted analysis may be essential to ensure validity of the results. Special considerations are required when selecting a randomization procedure for a clinical trial with very small sample size.
conclusionsThe choice of randomization design, data analytic technique (parametric or nonparametric), and analysis strategy (randomization-based or population model-based) are all very important considerations. Randomization-based tests are robust and valid alternatives to likelihood-based tests and should be considered more frequently by clinical investigators.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.