Vol 4, No 3 (September 25, 2015): Chinese Clinical Oncology (Clinical Trials in the Genome Era—Study Designs and Endpoints, Practical Considerations - Guest Editors: Daniel Sargent, Sumithra Mandrekar and Axel Grothey)

Review Article

Statistical principles for omics-based clinical trials
Michael C. Sachs
Molecular and clinical implementations of ovarian cancer mouse avatar models
Amira A. Zayed, Sumithra J. Mandrekar, Paul Haluska
An overview of the NCI precision medicine trials—NCI MATCH and MPACT
Khanh Do, Geraldine O’Sullivan Coyne, Alice P. Chen
Design and statistical principles of the SHIVA trial
Xavier Paoletti, Bernard Asselain, Maud Kamal, Nicolas Servant, Philippe Huppé, Ivan Bieche, Christophe Le Tourneau
An overview of the design and conduct of the BATTLE trials
Suyu Liu, J. Jack Lee
The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2− invasive breast cancer
Vera Jean Suman, Matthew J. Ellis, Cynthia X. Ma
The FOCUS4 design for biomarker stratified trials
Richard Kaplan
Lung-MAP—framework, overview, and design principles
Renata Ferrarotto, Mary W. Redman, David R. Gandara, Roy S. Herbst, Vassiliki A. Papadimitrakopoulou
Designing a definitive trial for adjuvant targeted therapy in genotype defined lung cancer: the ALCHEMIST trials
Ryan S. Alden, Sumithra J. Mandrekar, Geoffrey R. Oxnard
Biomarker-based trials in neuro-oncology
Karla V. Ballman


The supplement “Clinical Trials in the Genome Era—Study Designs and Endpoints, Practical Considerations” was commissioned by the Editorial office, Chinese Clinical Oncology without any sponsorship or funding. Daniel Sargent, Sumithra Mandrekar and Axel Grothey served as the unpaid Guest Editors for the supplement.