Webb11 dec. 2024 · A Two-stage Simon Design Phase II Study for Non-BRCA MBC Patients With HRD Treated With Olaparib Single Agent (NOBROLA) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for …
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WebbSimon, R. (1989) Optimal Two-Stage Designs for Phase II Clinical Trial. Controlled Clinical Trials, 10, 1-10. Login. ... Among 21 patients who were followed up for more than 2 years, 14 survived during that time. Webb4 mars 2024 · Simon’s optimal design is the most commonly used adaptive design method for phase II oncology studies. According to a survey conducted by Ivanova et al. [ 2 ], more than 40% of the phase II oncology trials with results published in leading oncology journals between 2010 and 2015 used this design. いわびつ 登山
A Two-stage Simon Design Phase II Study for Non-BRCA MBC …
WebbMultiple-stage designs including two-stage and three-stage have been developed by several authors. For example, Simon's optimal two-stage design [Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10], Ensign et al. optimal three-stage design with restriction at the first stage [Ensign LG, Gehan EA ... Webbfor an effective agent) are fulfilled. Simon’s design [7] is the most frequently used single-arm Phase II design in oncology drug development [8]. This design minimizes the … Webb2 Two-stage designs with and without curtailment rules 2.1 Minimax and optimal designs The objective of Simon’s two-stage design is to test whether a new treatment should be developed any further. To allow for early stopping if the treatment is ineffective—that is, if the response rate p is less than or equal to a prespecified value, p 0 ... pacotes caribe all inclusive 2023