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2022 | 69 | 4 | 20-28

Article title

Sample size in clinical trials – challenges and approaches

Content

Title variants

Languages of publication

Abstracts

EN
Sample size estimation is a necessary and crucial step in clinical trial research. Statistical requirements, limited patient availability and high financial risk of a clinical trial necessitate the proper calculation of this measure. The aim of this paper is to discuss the reasons why the estimation of the sample size is important and, based on the obtained results, to show how this process may be completed in selected cases. Stochastic simulations based on the Monte Carlo methods approach are applied. Therefore, new challenges facing this area of research are mentioned.

Year

Volume

69

Issue

4

Pages

20-28

Physical description

Dates

published
2022

Contributors

  • University of Silesia in Katowice, Institute of Mathematics
  • Parexel FSP, Parexel International

References

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  • Chow, S.-C., Wang, H., & Shao, J. (2007). Sample Size Calculations in Clinical Research (2nd edition). CRC Press. https://doi.org/10.1201/9781584889830.
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  • Faul, F., Erdfelder, E., Buchner, A., & Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41(4), 1149–1160. https://doi.org/10.3758/BRM.41.4.1149.
  • Hayes, M. H. S., & Patterson, D. G. (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18(2), 98–99.
  • Jiang, Z., Wang, L., Li, C., Xia, J., & Jia, H. (2012). A Practical Simulation Method to Calculate Sample Size of Group Sequential Trials for Time-to-Event Data under Exponential and Weibull Distribution. PLOS ONE, 7(9), 1–10. https://doi.org/10.1371/journal.pone.0044013.
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  • Raosoft. (2004). Raosoft Sample Size Calculator. http://www.raosoft.com/samplesize.html.
  • Szreder, M. (2022). Szanse i iluzje dotyczące korzystania z dużych prób we wnioskowaniu statystycznym. Wiadomości Statystyczne. The Polish Statistician, 67(8), 1–16. https://doi.org/10.5604/01.3001.0015.9704.
  • U.S. Food and Drug Administration. (n.d.). Guidance for Industry. E9 Statistical Principles for Clinical Trials. Retrieved September 11, 2019, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e9-statistical-principles-clinical-trials.
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  • Yeh, J., Gupta, S., Patel, S. J., Kota, V., & Guddati, A. K. (2020). Trends in the crossover of patients in phase III oncology clinical trials in the USA. Ecancermedicalscience, 14, 1–8. https://doi.org/10.3332/ecancer.2020.1142.

Document Type

Publication order reference

Identifiers

Biblioteka Nauki
2204289

YADDA identifier

bwmeta1.element.ojs-doi-10_59139_ps_2022_04_2
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