Download PDF by Shigeyuki Matsui, Marc Buyse, Richard Simon: Design and Analysis of Clinical Trials for Predictive

By Shigeyuki Matsui, Marc Buyse, Richard Simon

ISBN-10: 1466558164

ISBN-13: 9781466558168

An rising scientific trials paradigm for predictive medication consists of the advance of molecular diagnostics to permit the prediction of the consequences of therapy or results of person sufferers. This publication bargains statistical suggestions on engaging in medical trials for predictive medication. It covers statistical subject matters appropriate to the most scientific examine levels for constructing molecular diagnostics and Read more...

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False discovery rates (FDRs) are often useful in these settings in addition to generalization of p-values. For a comprehensive review of this topic, see Chapter 13 of this book, and also [28]. One should clearly specify the type and interpretation of overall error rate under consideration, as well as the method and assumptions used for calculation. Choice of methods should be guided by project objectives and follow-up plans. Permutation tests can be very useful to provide a more realistic estimate of the FDR especially when complex statistical criteria are applied.

We hope that this high-level overview will be of use to any biostatistician embarking on drug development projects where diagnostic hypothesis is considered. References 1. Herper M. The truly staggering cost of inventing new drugs. Forbes, 2012; 189(4):38–39. 2. FDA. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. FDA website, Washington, DC, 2004. 3. Oldenhuis CN, Oosting SF, Gietema JA et al. Prognostic vs predictive value of biomarkers in oncology.

1 Overall Considerations.................................................................... 2 Operational Considerations............................................................ 3 Statistical Considerations................................................................ 1 Defining Decision Rules.................................................... 2 Sample Size Considerations.............................................. 3 Brief Phase III Considerations.....................................................................

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Design and Analysis of Clinical Trials for Predictive Medicine by Shigeyuki Matsui, Marc Buyse, Richard Simon


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