2025
Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials
Moseley A, LeBlanc M, Freidlin B, Shallis R, Zeidan A, Sallman D, Erba H, Little R, Othus M. Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials. Clinical Trials 2025, 22: 361-366. PMID: 39815460, PMCID: PMC12143638, DOI: 10.1177/17407745241304065.Peer-Reviewed Original ResearchStratified analysisSample sizeRandomization ratioRandomization methodType 1 errorStratified block randomizationRandomized clinical trialsUnstratified analysisBlock randomizationStratification factorsClinical trialsStratification subgroupsTrialsPhase 2 trialDecreased powerSubgroupsRandomized phase 2 clinical trialFactorsRandomizationRandomized phase 2 trial
2024
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials
Tong G, Nevins P, Ryan M, Davis-Plourde K, Ouyang Y, Macedo J, Meng C, Wang X, Caille A, Li F, Taljaard M. A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials. Clinical Trials 2024, 22: 45-56. PMID: 39377196, PMCID: PMC11810615, DOI: 10.1177/17407745241276137.Peer-Reviewed Original ResearchSmall-sample correctionsStepped-wedge cluster randomized trialCluster randomized trialSample size calculation methodGeneralized linear mixed modelsLongitudinal correlation structureSize calculation methodLinear mixed modelsPermutation testSample sizeBayesian approachRandomized trialsCorrelation structureMixed modelsBayesian analysisGeneralized Estimating EquationsPermutationMedian sample sizeIntervention conditionRandomization methodEquationsBenchmarking Mendelian randomization methods for causal inference using genome-wide association study summary statistics
Hu X, Cai M, Xiao J, Wan X, Wang Z, Zhao H, Yang C. Benchmarking Mendelian randomization methods for causal inference using genome-wide association study summary statistics. American Journal Of Human Genetics 2024, 111: 1717-1735. PMID: 39059387, PMCID: PMC11339627, DOI: 10.1016/j.ajhg.2024.06.016.Peer-Reviewed Original ResearchConceptsMendelian randomizationMR methodsGenome-wide association study summary statisticsMendelian randomization methodsCausal inferenceInvalid instrumental variablesType I error controlInstrumental variablesCausal effect estimationIV assumptionsEffect estimatesSummary statisticsTwo-sampleGenetic variantsTrait pairsConfoundingGenetic datasetsGenetic dataConfounding scenariosRandomization methodInferencePractical guidanceSimulated datasetsGuidelinesStudySequential covariate-adjusted randomization via hierarchically minimizing Mahalanobis distance and marginal imbalance
Yang H, Qin Y, Li Y, Hu F. Sequential covariate-adjusted randomization via hierarchically minimizing Mahalanobis distance and marginal imbalance. Biometrics 2024, 80: ujae047. PMID: 38801258, DOI: 10.1093/biomtc/ujae047.Peer-Reviewed Original ResearchConceptsCovariate balanceMarginal imbalanceAdaptive randomization methodsTreatment effect estimatesSequential allocation schemeModified Mahalanobis distanceRandomization methodSimulation studyCovariate imbalanceRandom processTheoretical guaranteesCovariatesImbalance measureEffect estimatesMahalanobis distanceCurrent patientSample size differencesMarginal balanceAllocation schemeConvergenceData analysisSuperior performance
2021
Testing for treatment effect in covariate-adaptive randomized trials with generalized linear models and omitted covariates
Li Y, Ma W, Qin Y, Hu F. Testing for treatment effect in covariate-adaptive randomized trials with generalized linear models and omitted covariates. Statistical Methods In Medical Research 2021, 30: 2148-2164. PMID: 33899607, DOI: 10.1177/09622802211008206.Peer-Reviewed Original ResearchConceptsCovariate-adaptive randomizationCovariate-adaptive randomization methodsCovariate-adaptive randomized trialsValidity of statistical inferenceInflated type I errorLinear modelType I errorGeneralized linear modelAsymptotic distributionProposed adjustment methodAsymptotic resultsInferential propertiesTest statisticsAnti-conservativeStatistical inferenceContinuous responseUnadjusted testsNull hypothesisTheoretical findingsTreatment effectsInvalid testsRandomization methodNumerical studyCovariatesAdjustment method
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