Table of Contents Author Guidelines Submit a Manuscript
Computational and Mathematical Methods in Medicine
Volume 2015, Article ID 210817, 6 pages
http://dx.doi.org/10.1155/2015/210817
Research Article

The Direct Assignment Option as a Modular Design Component: An Example for the Setting of Two Predefined Subgroups

1Department of Mathematics, Vassar College, 124 Raymond Avenue, Poughkeepsie, NY 12604, USA
2Emory University, Atlanta, GA 30322, USA
3Mayo Clinic, Rochester, MN 55905, USA

Received 25 November 2014; Revised 29 December 2014; Accepted 29 December 2014

Academic Editor: Maria N. D. S. Cordeiro

Copyright © 2015 Ming-Wen An et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. M.-W. An, S. J. Mandrekar, and D. J. Sargent, “A 2-stage phase II design with direct assignment option in stage II for initial marker validation,” Clinical Cancer Research, vol. 18, no. 16, pp. 4225–4233, 2012. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  2. A. Lièvre, J.-B. Bachet, V. Boige et al., “KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with Cetuximab,” Journal of Clinical Oncology, vol. 26, no. 3, pp. 374–379, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  3. L. V. Rubinstein, E. L. Korn, B. Freidlin, S. Hunsberger, S. Percy Ivy, and M. A. Smith, “Design issues of randomized phase II trials and a proposal for phase II screening trials,” Journal of Clinical Oncology, vol. 23, no. 28, pp. 7199–7206, 2005. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  4. S. J. Mandrekar and D. J. Sargent, “Predictive biomarker validation in practice: lessons from real trials,” Clinical Trials, vol. 7, no. 5, pp. 567–573, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  5. B. Freidlin, L. M. McShane, and E. L. Korn, “Randomized clinical trials with biomarkers: design issues,” Journal of the National Cancer Institute, vol. 102, no. 3, pp. 152–160, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  6. B. Freidlin, Z. Sun, R. Gray, and E. L. Korn, “Phase III clinical trials that integrate treatment and biomarker evaluation,” Journal of Clinical Oncology, vol. 31, no. 25, pp. 3158–3161, 2013. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  7. B. Freidlin, E. L. Korn, and R. Gray, “Marker Sequential Test (MaST) design,” Clinical Trials, vol. 11, no. 1, pp. 19–27, 2014. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus