Journal of Biometrics & Biostatistics

Novotny PJ

Publications

• Research Article
  The Clinical Significance of Effect Sizes for Survival and Tumor Response Endpoints Using the Empirical Rule Effect Size
  Author(s): Major-Elechi BT, Sloan JA, Novotny PJ, Sargent DJ, Grothey A, Lafky JM and Dueck ACMajor-Elechi BT, Sloan JA, Novotny PJ, Sargent DJ, Grothey A, Lafky JM and Dueck AC
  
  Context: In planning oncology phase II and phase III clinical trials, the size of the expected effect for endpoints such as tumor response and overall survival are key parameters driving the sample size. We applied the empirical rule effect size approach, also known as the ½ standard deviation (SD) method, to define clinically significant effect sizes for overall survival and tumor response endpoints in a series of clinical trials. Methods: The observed effect size was calculated for 12 phase II and 27 phase III completed cancer clinical trials identified by experts as being notable. Results: The effect sizes of the phase II and phase III clinical trials ranged from -0.32 to 0.84 and 0.01 to 0.44 SDs respectively. Effect sizes for all but four of the phase II trials were less than a ½ SD. For phase II.. Read More»
  DOI: 10.37421/jbmbs.2019.10.433

  Abstract PDF