The group aims to bring the well known results in the scientific literature into practice and attract attention to basic principles of randomization techniques including pro and cons of particular procedures. The Randomization Working Group is actively welcoming new members. If you are interested in joining or if you have further questions, please contact us. Hi guys
In Summer 2022, the Randomization Working Group conducted an online survey on the current practices in the application of randomization in clinical trials. Of 145 unique respondents, 137 (94.5%) identified themselves as statisticians. Full Article: https://www.tandfonline.com/doi/abs/10.1080/19466315.2023.2225451
Randomization is a critical aspect of the clinical trial. Regulatory guidance plays a role in clinical research. Randomization tests provide valid methodology for statistical inference. In the present paper, we intended to survey: (a) information contained in regulatory guidance on randomization; and (b) the use of randomization tests in trials supporting marketing applications. This systematic review used the Cortellis Regulatory Intelligence database (IDRAC). For (a), of n = 156 guidance documents, nine provided recommendations on randomization methods. For (b), n = 48 trials (52 submissions) employed randomization tests. 40 (83.3%) were phase III trials, 31 (64.6%) employed dynamic allocation. Randomization test was the primary in 5 (10.4%), and sensitivity analysis in 34 (70.8%) trials...
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