دورية أكاديمية
Applications of the prediction of satisfaction design for monitoring single-arm phase II trials.
| العنوان: | Applications of the prediction of satisfaction design for monitoring single-arm phase II trials. |
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| المؤلفون: | Djeridi Z; Department of Mathematics, University of Jijel, Jijel, Algeria.; ACED Laboratory University of 8 May 1945 Guelma, Guelma, Algeria., Ghouar A; Preparatory Department, Higher School of Management Sciences-Annaba, Annaba, Algeria., Boulares H; ACED Laboratory University of 8 May 1945 Guelma, Guelma, Algeria.; Department of Mathematics, University of 8 May 1945 Guelma, Guelma, Algeria., Bouye M; Department of Mathematics, College of Science, King Khalid University, Abha, Saudi Arabia. |
| المصدر: | PloS one [PLoS One] 2024 Sep 26; Vol. 19 (9), pp. e0305814. Date of Electronic Publication: 2024 Sep 26 (Print Publication: 2024). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: San Francisco, CA : Public Library of Science |
| مواضيع طبية MeSH: | Clinical Trials, Phase II as Topic*/methods , Bayes Theorem* , Research Design*, Humans ; Lung Neoplasms ; Sample Size |
| مستخلص: | Prediction of satisfaction design, with binary endpoints, is an innovative strategy for phase II trials. We explain this hybrid frequentist-Bayesian strategy with an adept statistical plan and thorough findings, incorporating a description of study design features such as the sample size and the beta prior distribution, to simplify the Bayesian design. We also provide a set of tables and figures ranging from the stopping boundary for futility to the prediction of satisfaction, performance (type I error, power, and the probability of early termination PET), and sensitivity analysis for prediction of satisfaction. The statistical plan includes the operating characteristics through simulation study. Several trial examples from phase II lung cancer studies demonstrate the approach's practical use. The prediction of satisfaction design presents a flexible method in clinical study. This statistical study adds value to the application by broadening its scope. Competing Interests: The authors have declared that no competing interests exist. (Copyright: © 2024 Djeridi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.) |
| تواريخ الأحداث: | Date Created: 20240926 Date Completed: 20240926 Latest Revision: 20240926 |
| رمز التحديث: | 20240927 |
| DOI: | 10.1371/journal.pone.0305814 |
| PMID: | 39325832 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1932-6203 |
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| DOI: | 10.1371/journal.pone.0305814 |