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A Systematic Approach to Preclinical and Clinical Safety Biomarker Qualification Incorporating Bradford Hill's Principles of Causality Association
Author(s) -
Chetty R K,
Ozer J S,
Lanevschi A,
SchuppeKoistinen I,
McHale D,
Pears J S,
Vonderscher J,
Sistare F D,
Dieterle F
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.77
Subject(s) - biomarker , clinical pharmacology , food and drug administration , drug development , medicine , causality (physics) , agency (philosophy) , regulatory science , drug , risk analysis (engineering) , medical physics , pharmacology , pathology , biology , biochemistry , physics , philosophy , epistemology , quantum mechanics
The recently issued FDA/EMEA (US Food and Drug Administration/European Medicines Agency) guidelines pertaining to qualification of biomarkers are an important development in the regulatory approval process for new drug applications. 1 , 2 A qualified biomarker approved by regulatory authorities allows sponsors across industry to use that marker in new drug applications on the basis of a single submission rather than requiring each sponsor to present a separate justification with each new drug application. Nevertheless, there are a number of unanswered questions regarding the specific criteria that such a biomarker should meet in order to be considered as adding value to historical clinical end points and preclinical pathology observations. There are also questions regarding the optimal methods of collecting and evaluating scientific evidence for the clinical qualification of a biomarker. We propose a novel application to assist and accelerate the drug development process by prioritizing biomarker candidates and evidence, an application based on Bradford Hill's principles of causality association. Clinical Pharmacology & Therapeutics (2010) 88 2, 260–262. doi: 10.1038/clpt.2010.77