Abstract
To avoid deterministic treatment allocations in the permuted block design (PBD), many clinical trialists prefer randomizing the block sizes as well. While such a procedure is rarely formalized, it is generally assumed that the design will be less predictable. In this paper, we formalize the random block design by assuming a discrete uniform distribution for block size. The aim of this study is to provide a statistical understanding of the RBD, by investigating its distributional properties, including the degree of predictability and variability of treatment imbalance.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Berger, V.W.: Selection Bias and Covariate Imbalance in Randomized Clinical Trials. Wiley, Chichester (2005)
Blackwell, D., Hodges, J.L.: Design for the control of selection bias. Ann. Math. Stat. 28, 449–460 (1957)
Chen, Y.P.: Which design is better? Ehrenfest urn versus biased coin. Adv. Appl. Probab. 32, 738–749 (2000)
Heussen, N.: Der Einfluss der Randomisierung in Blöcken zufälliger Länge auf die Auswertung klinischer Studien mittels Randomisationstest. RWTH Aachen University, Aachen (2004)
Macian, N., Pereira, B., Shinjo, C., Dubray, C., Pickering, G.: Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial. Trials 16, 134 (2015)
Matts, J.P., Lachin, J.M.: Properties of permuted-block randomization in clinical trials. Control. Clin. Trials 9, 327–344 (1988)
Shah, B., Berger, J.S., Amoroso, N.S., Mai, X., Lorin, J.D., Danoff, A., Schwartzbard, A.Z., Lobach, I., Guo, Y., Feit, F., Slater, J., Attubato, M.J., Sedlis, S.P.: Periprocedural glycemic control in patients with diabetes mellitus undergoing coronary angiography with possible percutaneous coronary intervention. Am. J. Cardiol. 113, 1474–1480 (2014)
Shao, H.: Exact properties of restricted randomization procedures. George Mason University, Fairfax (2015)
Zhao, W., Weng, Y., Wu, Q., Palesch, Y.: Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness. Pharm. Stat. 11, 39–48 (2012)
Acknowledgements
Professor Rosenberger was supported by a scholarship from the German-American Fulbright Kommission, and also by the Department of Medical Statistics, RWTH Aachen University.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer International Publishing Switzerland
About this paper
Cite this paper
Shao, H., Rosenberger, W.F. (2016). Properties of the Random Block Design for Clinical Trials. In: Kunert, J., Müller, C., Atkinson, A. (eds) mODa 11 - Advances in Model-Oriented Design and Analysis. Contributions to Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-31266-8_26
Download citation
DOI: https://doi.org/10.1007/978-3-319-31266-8_26
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-31264-4
Online ISBN: 978-3-319-31266-8
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)