التفاصيل البيبلوغرافية
| العنوان: |
A new statistical decision rule for single-arm phase II oncology trials. |
| المؤلفون: |
Chen, Yiyi1 chenyiy@ohsu.edu, Chen, Zunqiu1, Mori, Motomi1 |
| المصدر: |
Statistical Methods in Medical Research. Feb2016, Vol. 25 Issue 1, p118-132. 15p. |
| مصطلحات موضوعية: |
*EXPERIMENTAL oncology, *TREATMENT effectiveness, *MEDICAL statistics, *CLINICAL trials, *RANDOMIZED controlled trials, *TUMOR treatment, *PANCREATIC tumors, *DECISION making, *PROBABILITY theory, *PROGNOSIS, *RESEARCH funding, *STATISTICS, *STATISTICAL models |
| مستخلص: |
Most single-arm phase II clinical trials compare the efficacy of a new treatment with historical controls through statistical hypothesis testing. One major problem with such a comparison is that the efficacy of the historical control is treated as a known constant, whereas in reality, it is never precisely known. This partially explains why many "Go" decisions made in single-arm phase II trials are shown to be incorrect in phase III trials. In this paper, we propose a new decision rule for an improved transitional decision for single-arm phase II oncology clinical trials with binary endpoints. This new decision rule is jointly based on the p value and a new statistical index named the testing confidence value. The testing confidence value reflects the uncertainty associated with the null value in the hypothesis testing of single-arm trials. Simulations are used to evaluate the operating characteristics of the new decision rule in comparison with the traditional decision rule and a widely used Bayesian decision rule. The application of the new decision rule is illustrated using a clinical trial on marginally resectable pancreatic cancer. A webpage http://www.yiyichenbiostatistics.com/TCV.html is available for readers to interactively compute the testing confidence value and to find the suggested decision based on the new decision rule. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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