A statistician's perspective on biomarkers in drug development

Author:

Jenkins Martin1,Flynn Aiden2,Smart Trevor3,Harbron Chris1,Sabin Tony4,Ratnayake Jayantha5,Delmar Paul6,Herath Athula7,Jarvis Philip1,Matcham James4,

Affiliation:

1. AstraZeneca UK Ltd.; Alderley Park Macclesfield UK

2. Exploristics; Belfast UK

3. Pfizer; Sandwich, Kent UK

4. Amgen Limited; Cambridge Science Park Cambridge UK

5. Roche Products Limited; Shire Park Welwyn Garden City UK

6. Hoffman-La Roche; Basel Switzerland

7. MedImmune; Granta Park Cambridge UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference109 articles.

1. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework;Atkinson;Clinical Pharmacology and Therapeutics,2001

2. An approach to the validation of markers for the use in AIDS clinical trials;Mildvan;Clinical Infectious Diseases,1997

3. Definitions and validation Criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema;Lassere;Journal of Rheumatology,2007

4. A prototypical process for creating evidentiary standards for biomarkers and diagnostics;Altar;Clinical Pharmacology and Therapeutics,2008

5. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer;De Bono;Clinical Cancer Research,2008

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