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Freidlin B, Little R, Korn E. Design Issues in Randomized Clinical Trials of Maintenance Therapies. J Natl Cancer Inst. 2015;107:
..Toxicity and symptom information over both the study treatment (maintenance) and the second-line treatment should also be collected and reported. ..
Freidlin B, Korn E, Gray R. A general inefficacy interim monitoring rule for randomized clinical trials. Clin Trials. 2010;7:197-208
..At the same time, the proposed rule provides a clear benchmark for providing compelling evidence that the new therapy is not beneficial. Clinical Trials 2010; 7: 197-208. http://ctj.sagepub.com. ..
Freidlin B, Othus M, Korn E. Information time scales for interim analyses of randomized clinical trials. Clin Trials. 2016;13:391-9
..Improving the timing of interim analyses helps to minimize patient exposure to inferior treatments and to accelerate dissemination of the study results. ..
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