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Pick the Winner Designs in Phase II Cancer Clinical Trials

Pick the Winner Designs in Phase II Cancer Clinical Trials EDITORIAL Sumithra J. Mandrekar, PhD, and Daniel J. Sargent, PhD (J Thorac Oncol. 2006;1: 5–6) n this issue of the Journal of Thoracic Oncology, Masters et al. present the results of Ia randomized phase II trial evaluating two schedules of gemcitabine and carboplatin in patients with advanced non–small-cell lung cancer using a “selection design.” Assuming a hazard rate of 1.2 for progression-free survival, the authors state that a sample of 50 patients per arm provided at least an 80% chance of picking the correct regimen using a one-sided log rank test. Unfortunately, the statistical section is rather brief, with no references cited for the selection design used; hence, the exact calculations could not be verified. This is not uncommon in the literature; only 60 of the 266 randomized phase II trials included in a recent literature review had an identifiable statistical design section. Given the recent increased interest in randomized phase II trials, driven primarily by the need to evaluate the efficacy of multiple regimens concurrently, a detailed description of the design, conduct, analysis, and interpretation of the trial results is vital to assess the scientific merits and improve our understanding of these designs. We present some of the http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Thoracic Oncology Wolters Kluwer Health

Pick the Winner Designs in Phase II Cancer Clinical Trials

Sargent, Daniel J.
Journal of Thoracic Oncology , Volume 1 (1) – Jan 1, 2006
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1556-0864

Abstract

EDITORIAL Sumithra J. Mandrekar, PhD, and Daniel J. Sargent, PhD (J Thorac Oncol. 2006;1: 5–6) n this issue of the Journal of Thoracic Oncology, Masters et al. present the results of Ia randomized phase II trial evaluating two schedules of gemcitabine and carboplatin in patients with advanced non–small-cell lung cancer using a “selection design.” Assuming a hazard rate of 1.2 for progression-free survival, the authors state that a sample of 50 patients per arm provided at least an 80% chance of picking the correct regimen using a one-sided log rank test. Unfortunately, the statistical section is rather brief, with no references cited for the selection design used; hence, the exact calculations could not be verified. This is not uncommon in the literature; only 60 of the 266 randomized phase II trials included in a recent literature review had an identifiable statistical design section. Given the recent increased interest in randomized phase II trials, driven primarily by the need to evaluate the efficacy of multiple regimens concurrently, a detailed description of the design, conduct, analysis, and interpretation of the trial results is vital to assess the scientific merits and improve our understanding of these designs. We present some of the

Journal

Journal of Thoracic Oncology – Wolters Kluwer Health

Published: Jan 1, 2006

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