Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect.

作者: W. Jiang , B. Freidlin , R. Simon

DOI: 10.1093/JNCI/DJM022

关键词:

摘要: … We propose a statistically rigorous biomarker-adaptive threshold phase III design for settings in which a putative biomarker to identify patients who are sensitive to the new agent is …

参考文章(15)
Richard M Simon, Edward L Korn, Lisa M McShane, Michael D Radmacher, George W Wright, Yingdong Zhao, Design and Analysis of DNA Microarray Investigations ,(2003)
Ming-Sound Tsao, Akira Sakurada, Jean-Claude Cutz, Chang-Qi Zhu, Suzanne Kamel-Reid, Jeremy Squire, Ian Lorimer, Tong Zhang, Ni Liu, Manijeh Daneshmand, Paula Marrano, Gilda da Cunha Santos, Alain Lagarde, Frank Richardson, Lesley Seymour, Marlo Whitehead, Keyue Ding, Joseph Pater, Frances A. Shepherd, Erlotinib in lung cancer - molecular and clinical predictors of outcome. The New England Journal of Medicine. ,vol. 353, pp. 133- 144 ,(2005) , 10.1056/NEJMOA050736
Rupert Miller, David Siegmund, Maximally Selected Chi Square Statistics Biometrics. ,vol. 38, pp. 1011- ,(1982) , 10.2307/2529881
David P. Byar, Donald K. Corle, Selecting optimal treatment in clinical trials using covariate information Journal of Chronic Diseases. ,vol. 30, pp. 445- 459 ,(1977) , 10.1016/0021-9681(77)90037-6
D. G. Altman, B. Lausen, W. Sauerbrei, M. Schumacher, Dangers of using "optimal" cutpoints in the evaluation of prognostic factors. Journal of the National Cancer Institute. ,vol. 86, pp. 829- 835 ,(1994) , 10.1093/JNCI/86.11.829
Lawrence V. Rubinstein, Mitchell H. Gail, Thomas J. Santner, Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation Journal of Chronic Diseases. ,vol. 34, pp. 469- 479 ,(1981) , 10.1016/0021-9681(81)90007-2
R Simon, DG Altman, Statistical aspects of prognostic factor studies in oncology British Journal of Cancer. ,vol. 69, pp. 979- 985 ,(1994) , 10.1038/BJC.1994.192
Richard Simon, Problems of multiplicity in clinical trials Journal of Statistical Planning and Inference. ,vol. 42, pp. 209- 221 ,(1994) , 10.1016/0378-3758(94)90197-X