Evaluating Treatment Effect Based on Duration of Response for a Comparative Oncology Study

Author:

Huang Bo1,Tian Lu2,Talukder Enayet1,Rothenberg Mace3,Kim Dae Hyun4,Wei Lee-Jen5

Affiliation:

1. Pfizer Inc, Groton, Connecticut

2. Stanford Medical School, Stanford University, Stanford, California

3. Pfizer Inc, New York, New York

4. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

5. Department of Biostatistics, Harvard University, Boston, Massachusetts

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Reference6 articles.

1. Analysis of duration of response in oncology trials.;Ellis;Contemp Clin Trials,2008

2. First-line crizotinib versus chemotherapy in ALK-positive lung cancer.;Solomon;N Engl J Med,2014

3. Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis.;Uno;J Clin Oncol,2014

4. Interpretability of cancer clinical trial results using restricted mean survival time as an alternative to the hazard ratio;Pak;JAMA Oncol,2017

5. US Food and Drug Administration. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. Washington, DC, US Food and Drug Administration. 2007 May:1-9. https://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf. Accessed January 8, 2018.

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