Randomization in clinical trials
DOI:
https://doi.org/10.5281/zenodo.11046985Keywords:
Randomization, Random Allocation, Research DesignsAbstract
Blinding, randomization and control group are used in randomized controlled trial designs to obtain scientific medical evidence. The aim of this article is to examine the definition and purpose of randomization and randomization methods. Randomization is the assignment of participants to study groups homogeneously in terms of all characteristics that may be confounding factors predicted by the investigator. The aim of randomization is to create a control group that is as similar as possible to the treatment group by helping to reduce selection bias and to balance known and unknown confounding factors. There are various methods for randomization. In this article, simple, block and stratified randomization methods, which are most commonly used in practice, will be discussed in detail. In conclusion, randomization is a practice that remains important in clinical trials with multiple arms.
References
Byar DP, Simon RM, Friedewald WT, Schlesselman JJ, DeMets DL, Ellenberg JH, et al. Randomized clinical trials. Perspectives on some recent ideas. N Engl J Med. 1976;295(2):74–80. doi: 10.1056/NEJM197607082950204
Collins R, Bowman L, Landray M, Peto R. The Magic of Randomization versus the Myth of Real-World Evidence. N Engl J Med. 2020 Feb 13;382(7):674–8. doi: 10.1056/NEJMsb1901642
CHMP. ICH guideline E8 (R1) on general considerations for clinical studies. Ema/CHMP/ICH/544570/1998 [Internet]. 2019;8(October 2021):1–25. [Erişim tarihi: 16 Kasım 2023] Erişim adresi: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-8-general-considerations-clinical-trials-step-5_en.pdf
Fisher RA. Arrangment of Field Experiments. J Minist Agric. 1926;(33):503–13. [Erişim tarihi: 17 Kasım 2023] Erişim adresi: https://digital.library.adelaide.edu.au/dspace/bitstream/2440/15191/1/48.pdf
Kang M, Ragan BG, Park JH. Issues in outcomes research: An overview of randomization techniques for clinical trials. J Athl Train. 2008;43(2):215–21. doi: 10.4085/1062-6050-43.2.215
Amberson J.B, McMahon B.T PMA. Clinical trial of sanocrysin in pulmonary tuberculosis. Am Rev Tuberc. 1931 Feb;24:401–35. doi: 10.2105/AJPH.15.2.144
Berger VW, Bour LJ, Carter K, Chipman JJ, Everett CC, Heussen N, et al. A roadmap to using randomization in clinical trials. BMC Med Res Methodol. 2021;21(1):1–24. doi: 10.1186/s12874-021-01303-z
Verbeck WJ, Kroon AA, Kessels AGH, Nelemans PJ, Van Ree JW, Lenders JWM, et al. Comparison of randomization techniques for clinical trials with the data from the HOMERUS-trial. Blood Press. 2005;14(5):306–14. doi: 10.1080/08037050500331538
Raymond J, Valvassori L, Darsaut TE. Understanding the role of randomization in clinical research and practice. Neurochirurgie. 2023;69(6):101492. doi: 10.1016/j.neuchi.2023.101492
Kanik EA, Taşdelen B, Erdoǧan S. Klinik denemelerde randomizasyon. Marmara Med J. 2011;24(3):149–55. doi: 10.5472/MMJ.2011.01981.1
Altman DG, Bland JM. How to randomise. Br Med J. 1999;319(7211):703–4. doi: 10.1136/bmj.319.7211.703
Hedden SL, Woolson RF, Malcolm RJ. Randomization in substance abuse clinical trials. Subst Abus Treat Prev Policy. 2006;1(1):1–17. doi: 10.1186/1747-597X-1-6
Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019;72(3):221-32. doi: 10.4097/kja.19049
Weir CJ, Lees KR. Comparison of stratification and adaptive methods for treatment allocation in an acute stroke clinical trial. Stat Med. 2003;22(5):705–26. doi: 10.1002/sim.1366
Therneau TM. How many stratification factors are “too many” to use in a randomization plan? Control Clin Trials. 1993;14(2):98–108. doi: 10.1016/0197-2456(93)90013-4
Caparrotta TM, Dear JW, Colhoun HM, Webb DJ. Pharmacoepidemiology: Using randomised control trials and observational studies in clinical decision-making. Br J Clin Pharmacol. 2019;85(9):1907–24. doi: 10.1111/bcp.14024
Subbiah V. The next generation of evidence-based medicine. Nat Med. 2023;29(1):49-58. doi: 10.1038/s41591-022-02160-z
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Dec 24;8(1):18. doi: 10.1186/1741-7015-8-18
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