Abstract
This chapter covers the concepts of variance and sources of variation for clinical trial data. Common metrics to quantify the extent of variability in relation to the mean are introduced as are clinical trial design techniques and statistical analysis methods to control and reduce this variation. The uses of variance as a data quality assessment tool in large-scale, long-term multicenter clinical trials are highlighted.
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References
Barraza F, Arancibia M, Madrid E, Papuzinski C (2019) General concepts in biostatistics and clinical epidemiology: random error and systematic error. Medwave 19(7):e7687
Biau DJ, Kernéis S, Porcher R (2008) Statistics in brief: the importance of sample size in the planning and interpretation of medical research. Clin Orthop Relat Res 466(9):2282–2288
Chow SC, Liu JP (2014) Design and analysis of clinical trial, 3rd edn. Wiley, Hoboken, NJ. https://www.wiley.com/en-ug/Design+and+Analysis+of+Clinical+Trials%3A+Concepts+and+Methodologies%2C+3rd+Edition-p-9780470887653
European Medicines Agency (EMA) (2015) Guideline on adjustment for baseline covariates in clinical trials. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-adjustment-baseline-covariates-clinical-trials_en.pdf. Accessed 23 Mar 2021
Mathews J (2006) Introduction to randomized controlled clinical trials, 2nd edn. Chapter 6, p 78, Chapman & Hall/CRC Texts in Statistical Science. https://www.routledge.com/Introduction-to-Randomized-Controlled-Clinical-Trials/Matthews/p/book/9781584886242
Perini TA, de Oliveira GL, Ornellas J d S, de Oliveira FP (2005) Technical error of measurement in anthropometry. Rev Bras Med Esporte 11(1):81–85. https://doi.org/10.1590/S1517-86922005000100009
Simon LJ, Chinchilli VM (2007) A matched crossover design for clinical trials. Contemp Clin Trials 28(5):638–646. https://doi.org/10.1016/j.cct.2007.02.003
Suresh K (2011) An overview of randomization techniques: an unbiased assessment of outcome in clinical research. J Hum Reprod Sci 4(1):8–11. https://doi.org/10.4103/0974-1208.82352
Tango T (2016) On the repeated measures designs and sample sizes for randomized controlled trials. Biostatistics 17(2):334–349. https://doi.org/10.1093/biostatistics/kxv047
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research (2019) Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products guidance for industry. https://www.fda.gov/media/121320/download. Accessed 25 Mar 2021
Wang B, Ogburn E, Rosenblum M (2019) Analysis of Covariance (ANCOVA) in randomized trials: more precision, less conditional bias, and valid confidence intervals, without model assumptions. Biometrics 75:1391–1400
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Weiss, H.L., Wu, J., Epnere, K., Williams, O.D. (2022). Variance Control Procedures. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52636-2_218
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DOI: https://doi.org/10.1007/978-3-319-52636-2_218
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