Testing in a Prespecified Subgroup and the Intent-to-Treat Population

Drug Information Journal

Volumn 46, Issue 2, 2012, Pages 175-179

  Rothmann, Mark D ^a   Zhang, Jenny J ^a   Lu, Laura ^a   Fleming, Thomas R ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

Author keywords

biomarker; intent to treat; subgroup analysis

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; HUMAN; INFORMATION PROCESSING; INTENTION TO TREAT ANALYSIS; MEDICAL ERROR; PATIENT IDENTIFICATION; POPULATION; PRIORITY JOURNAL; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; THERAPY EFFECT; TREATMENT PLANNING;

EID: 84864820652     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/0092861512436579     Document Type: Article

References (6)

1. FDA Oncologic Drugs Advisory Committee, Dec 16, 2008 transcript. http://www.fda.gov/ohrms/dockets/ac/cder08.html#OncologicDrugs. Accessed February 8, 2012.
2. Freidlin B,Simon R.Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients.Clin Cancer Res. 2005;11:7872-7878.
3. Jiang W,Freidlin B,Simon R.Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect.J Natl Cancer Inst. 2007;99:1036-1043.
4. Simon R.New challenges for 21st century clinical trials.Clin Trials. 2007;4:167-169.
5. Simon R,Wang S-J.Use of genomic signatures in therapeutics development in oncology and other diseases.Pharmacogen J. 2006;6:166-173.
6. Wang S-J,O'Neill RT,Hung HMJ.Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset.Pharmaceut Statist. 2007;6:227-244.