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Small Randomized Trials

Small Randomized Trials EDITORIAL Mary Redman, PhD,* and John Crowley, PhD,† n this issue of the Journal, Buchholz et al. report on a trial that addresses the issue of Idose-intensity in the treatment of small cell lung cancer. The study was initially planned as a 40-patient (evidently randomized) phase II pilot and then was amended (because of promising interim results?) to include a maximum of 58 eligible patients per arm. The study was stopped with a total of 83 eligible patients on the third of five further planned interim analyses when the p value for the primary endpoint of 2-year survival was less than the stated boundary of 0.01 (the final report gives this p value as 0.15, but a log rank p value for overall survival of 0.001). Although we have some concerns regarding the design and reporting of study results, we focus here on the properties of small randomized studies. Small randomized trials can arise from overly optimistic specification of the benefit to be detected in a phase III trial (the idea that a “home run” is the only worthwhile hit); from planned or unplanned interim analyses of phase III trials, after too few events; or from the idea that http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Thoracic Oncology Wolters Kluwer Health

Small Randomized Trials

Crowley, John
Journal of Thoracic Oncology , Volume 2 (1) – Jan 1, 2007
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ISSN
1556-0864
DOI
10.1097/JTO.0b013e31802c8d84
pmid
17410001
Publisher site
See Article on Publisher Site

Abstract

EDITORIAL Mary Redman, PhD,* and John Crowley, PhD,† n this issue of the Journal, Buchholz et al. report on a trial that addresses the issue of Idose-intensity in the treatment of small cell lung cancer. The study was initially planned as a 40-patient (evidently randomized) phase II pilot and then was amended (because of promising interim results?) to include a maximum of 58 eligible patients per arm. The study was stopped with a total of 83 eligible patients on the third of five further planned interim analyses when the p value for the primary endpoint of 2-year survival was less than the stated boundary of 0.01 (the final report gives this p value as 0.15, but a log rank p value for overall survival of 0.001). Although we have some concerns regarding the design and reporting of study results, we focus here on the properties of small randomized studies. Small randomized trials can arise from overly optimistic specification of the benefit to be detected in a phase III trial (the idea that a “home run” is the only worthwhile hit); from planned or unplanned interim analyses of phase III trials, after too few events; or from the idea that

Journal

Journal of Thoracic Oncology – Wolters Kluwer Health

Published: Jan 1, 2007

References

  • Standard versus dose-intensified chemotherapy with sequential reinfusion of hematopoietic progenitor cells in small cell lung cancer patients with favorable prognosis
    Buchholz
  • A systematic review and meta-analysis of the literature: chemotherapy and surgery versus surgery alone in non-small cell lung caner
    Burdett
  • Phase II clinical trial design: methods in translational research from the genitourinary committee at the Eastern Cooperative Oncology Group
    Gray
  • Design issues of randomized phase ii trials and a proposal for phase ii screening trials
    Rubinstein
  • Phase II selection designs
    Liu
  • Progression-free survival rate as primary end point for phase ii cancer clinical trials: application to mesothelioma—The EORTC Lung Cancer Group
    Francart