Minimization, by its nature, precludes allocation concealment, and invites selection bias

Selection Bias and Covariate Imbalances in Randomized Clinical Trials

Berger, V. W. (2005) · Wiley eBooks · doi:10.1002/0470863641 · Cited by 261 · see citing works

Minimizing predictability while retaining balance through the use of less restrictive randomization procedures

Berger, V. W., Ivanova, A., & Knoll, M. D. (2003) · Statistics in Medicine · doi:10.1002/sim.1538 · Cited by 200 · see citing works

The use of minimization in clinical trials

Taves, D. R. (2010) · Contemporary Clinical Trials · doi:10.1016/j.cct.2009.12.005 · Cited by 140 · see citing works

Quantifying the Magnitude of Baseline Covariate Imbalances Resulting from Selection Bias in Randomized Clinical Trials

Berger, V. W. (2005) · Biometrical Journal · doi:10.1002/bimj.200410106 · Cited by 110 · see citing works

Sensitivity designs for preventing bias replication in randomized clinical trials

Berger, V. W., Grant, W. C., & Vazquez, L. F. (2010) · Statistical Methods in Medical Research · doi:10.1177/0962280209359875 · Cited by 13 · see citing works

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works

Allocation techniques for balance at baseline in cluster randomized trials: a methodological review

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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

The pursuit of balance: an overview of covariate-adaptive randomization techniques in clinical trials

Lin, Y., Zhu, M., & Su, Z. (2015) · Contemporary Clinical Trials · doi:10.1016/j.cct.2015.07.011 · Cited by 152 · see citing works

Adaptive Randomization for Clinical Trials

Rosenberger, W. F., Sverdlov, O., & Hu, F. (2012) · Journal of Biopharmaceutical Statistics · doi:10.1080/10543406.2012.676535 · Cited by 92 · see citing works

Minimal sufficient balance—a new strategy to balance baseline covariates and preserve randomness of treatment allocation

Zhao, W., Hill, M. D., & Palesch, Y. (2015) · Statistical Methods in Medical Research · doi:10.1177/0962280212436447 · Cited by 87 · see citing works

Recommendations for Statistical Reporting in Cardiovascular Medicine: A Special Report From the American Heart Association

Althouse, A. D., Below, J. E., Claggett, B. L., Cox, N. J., de Lemos, J. A., Deo, R. C., Duval, S., Hachamovitch, R., Kaul, S., Keith, S. W., et al. (2021) · Circulation · doi:10.1161/circulationaha.121.055393 · Cited by 71 · see citing works

A better alternative to stratified permuted block design for subject randomization in clinical trials

Zhao, W. (2014) · Statistics in Medicine · doi:10.1002/sim.6266 · Cited by 45 · see citing works

Sequential rerandomization

Zhou, Q., Ernst, P., Morgan, K. L., Rubin, D. B., & Zhang, A. R. (2018) · Biometrika · doi:10.1093/biomet/asy031 · Cited by 35 · see citing works

Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial

Bosch, M., McKenzie, J. E., Mortimer, D., Tavender, E. J., Francis, J., Brennan, S., Knott, J. C., Ponsford, J. L., Pearce, A. P., O’Connor, D. A., et al. (2014) · Trials · doi:10.1186/1745-6215-15-281 · Cited by 25 · see citing works

Selection bias, allocation concealment and randomization design in clinical trials

Zhao, W. (2013) · Contemporary Clinical Trials · doi:10.1016/j.cct.2013.07.005 · Cited by 24 · see citing works

A review of randomization methods in clinical trials

Berger, V. W., & Antsygina, O. (2015) · Clinical Investigation · doi:10.4155/cli.15.53 · Cited by 20 · see citing works

Randomization procedures for multicomponent behavioral intervention factorial trials in the multiphase optimization strategy framework: challenges and recommendations

Gallis, J. A., Bennett, G. G., Steinberg, D., Askew, S., & Turner, E. L. (2018) · Translational Behavioral Medicine · doi:10.1093/tbm/iby131 · Cited by 16 · see citing works

Minimization: not all it’s cracked up to be

Berger, V. W. (2011) · Clinical Trials · doi:10.1177/1740774511409769 · Cited by 11 · see citing works

Use and reporting of restricted randomization: a review

Higham, R., Tharmanathan, P., & Birks, Y. F. (2015) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.12408 · Cited by 10 · see citing works

Acupuncture for cancer pain: protocol for a pilot pragmatic randomised controlled trial

He, Y., May, B. H., Zhang, A. L., Guo, X., Liu, Y., Qu, Y., Chang, X., Lu, C., Xue, C. C., & Zhang, H. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-025564 · Cited by 9 · see citing works

Statistical properties of minimal sufficient balance and minimization as methods for controlling baseline covariate imbalance at the design stage of sequential clinical trials

Lauzon, S. D., Ramakrishnan, V., Nietert, P. J., Ciolino, J. D., Hill, M. D., & Zhao, W. (2020) · Statistics in Medicine · doi:10.1002/sim.8552 · Cited by 9 · see citing works

Letter to the editor in response to Berger

McEntegart, D. J. (2010) · Contemporary Clinical Trials · doi:10.1016/j.cct.2010.07.013 · Cited by 9 · see citing works

Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience

Zhao, W., Yeatts, S. D., Broderick, J. P., Selim, M. H., Adeoye, O. M., Durkalski‐Mauldin, V. L., Meinzer, C., Martin, R., Dillon, C. R., Cassarly, C. N., et al. (2023) · Stroke · doi:10.1161/strokeaha.122.040743 · Cited by 8 · see citing works

Impact of minimal sufficient balance, minimization, and stratified permuted blocks on bias and power in the estimation of treatment effect in sequential clinical trials with a binary endpoint

Lauzon, S. D., Zhao, W., Nietert, P. J., Ciolino, J. D., Hill, M. D., & Ramakrishnan, V. (2021) · Statistical Methods in Medical Research · doi:10.1177/09622802211055856 · Cited by 8 · see citing works

The effect of low vision rehabilitation in diabetic eye disease: a randomised controlled trial protocol

Dunbar, H., Crossland, M. D., Bunce, C., Egan, C. A., & Rubin, G. S. (2012) · Ophthalmic and Physiological Optics · doi:10.1111/j.1475-1313.2012.00914.x · Cited by 7 · see citing works

Minimization does not by its nature preclude allocation concealment and invite selection bias, as Berger claims

Taves, D. R. (2010) · Contemporary Clinical Trials · doi:10.1016/j.cct.2010.12.010 · Cited by 7 · see citing works

Managing competing demands in the implementation of response-adaptive randomization in a large multicenter phase III acute stroke trial

Zhao, W., & Durkalski, V. (2014) · Statistics in Medicine · doi:10.1002/sim.6213 · Cited by 6 · see citing works

Validity of studies suggesting postsurgical chemotherapy for resectable gastric cancer: critical appraisal of randomised trials

Manzini, G., Henne‐Bruns, D., & Kremer, M. (2017) · BMJ Open Gastroenterology · doi:10.1136/bmjgast-2017-000138 · Cited by 6 · see citing works

Comparison of statistical and operational properties of subject randomization procedures for large multicenter clinical trial treating medical emergencies

Zhao, W., Mu, Y., Tayama, D., & Yeatts, S. D. (2015) · Contemporary Clinical Trials · doi:10.1016/j.cct.2015.01.013 · Cited by 5 · see citing works

Adjuvant chemotherapy in curatively resected rectal cancer: How valid are the data?

Manzini, G., Hapke, F., Hines, I. N., Henne‐Bruns, D., & Kremer, M. (2020) · World Journal of Gastrointestinal Oncology · doi:10.4251/wjgo.v12.i4.503 · Cited by 3 · see citing works

A note on conditional and unconditional allocation concealment

Berger, V. W. (2014) · Clinical Investigation · doi:10.4155/cli.14.27 · Cited by 2 · see citing works

A unifying framework for standard and covariate-adaptive randomization procedures based on minimizing suitable imbalance functions

Berger, V. W. (2013) · Contemporary Clinical Trials · doi:10.1016/j.cct.2013.09.017 · Cited by 2 · see citing works

Continuous positive airway pressure after major abdominal surgery: an independent discussion of the Prevention of Respiratory Insufficiency after Surgical Management trial

Einav, S., & Mouton, R. (2021) · British Journal of Anaesthesia · doi:10.1016/j.bja.2021.05.012 · Cited by 2 · see citing works

Covariate‐Adaptive Randomization

Rosenberger, W. F., & Lachin, J. M. (2015) · Wiley series in probability and statistics · doi:10.1002/9781118742112.ch9 · Cited by 2 · see citing works

Validity of studies suggesting preoperative chemotherapy for resectable thoracic esophageal cancer: A critical appraisal of randomized trials Giulia Manzini, Ursula Klotz, Doris Henne-Bruns, Michael Kremer

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Minimisation for the design of parallel cluster-randomised trials: An evaluation of balance in cluster-level covariates and numbers of clusters allocated to each arm

Martín, J., Middleton, L., & Hemming, K. (2023) · Clinical Trials · doi:10.1177/17407745221149104 · Cited by 1 · see citing works

Different name, same problems

Berger, V. W. (2011) · Contemporary Clinical Trials · doi:10.1016/j.cct.2011.08.002 · Cited by 1 · see citing works

Randomization

Guyatt, G. H., & Alexander, P. E. (2013) · doi:10.4155/ebo.13.429 · Cited by 1 · see citing works

Run-Reversal Equilibrium for Clinical Trial Randomization

Grant, W. C. (2015) · PLoS ONE · doi:10.1371/journal.pone.0128812

Out of the Frying Pan and in to the Fire?

Berger, V. W. (2012) · Biometrics · doi:10.1111/j.1541-0420.2012.01804.x

Randomization Procedures

Berger, V. W., Grant, W. C., Dupin-Spriet, T., & Chappell, R. J. (2014) · doi:10.1002/9781118596005.ch68

Minimal Sufficient Balance – A Better Alternative to Minimization for Randomized Controlled Trials

Zhao, W. (2018) · Wiley StatsRef: Statistics Reference Online · doi:10.1002/9781118445112.stat08021

Can We Predict Bronchopulmonary Dysplasia Early in Life?

Kirpalani, H. M. (2021) · Neonatology · doi:10.1159/000516781

Prognostic Model–Guided Randomization Improves Efficiency in Early‐Phase Trials: Evidence From Surveys and Simulations

Zhang, S., Zhao, J., & Cao, Y. (2026) · Clinical and Translational Science · doi:10.1111/cts.70498

The pursuit of balance: an overview of covariate-adaptive randomization techniques in clinical trials

Lin, Y., Zhu, M., & Su, Z. (2015) · Contemporary Clinical Trials · doi:10.1016/j.cct.2015.07.011 · Cited by 152 · see citing works

Minimal sufficient balance—a new strategy to balance baseline covariates and preserve randomness of treatment allocation

Zhao, W., Hill, M. D., & Palesch, Y. (2015) · Statistical Methods in Medical Research · doi:10.1177/0962280212436447 · Cited by 87 · see citing works

Minimization in randomized clinical trials

Coart, E., Bamps, P., Quinaux, E., Sturbois, G., Saad, E. D., Burzykowski, T., & Buyse, M. E. (2023) · Statistics in Medicine · doi:10.1002/sim.9916 · Cited by 24 · see citing works

Adaptive randomization for balancing over covariates

Hu, F., Hu, Y., Ma, Z., & Rosenberger, W. F. (2014) · Wiley Interdisciplinary Reviews Computational Statistics · doi:10.1002/wics.1309 · Cited by 66 · see citing works

An overview of randomization and minimization programs for randomized clinical trials

Saghaei, M. (2011) · Journal of Medical Signals & Sensors · doi:10.4103/2228-7477.83520 · Cited by 133 · see citing works