Decoding the Pathway to Biomarker Qualification: Will an Evidentiary Map Framework Do the Trick?

(1) Biomarkers are vital for drug development, with potential safety (e.g., early identification of drug toxicity) and efficacy (e.g., response to therapy, end-point measures) benefits. [...]stakeholders are committed to developing pathways for effective biomarker qualification. Recently, the Center...

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Bibliographic Details
Published in:Clinical chemistry (Baltimore, Md.) Md.), 2018-05, Vol.64 (5), p.873-874
Main Author: Colón-Franco, Jessica M
Format: Article
Language:English
Subjects:
Biomarkers
Decoding
FDA approval
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Summary:(1) Biomarkers are vital for drug development, with potential safety (e.g., early identification of drug toxicity) and efficacy (e.g., response to therapy, end-point measures) benefits. [...]stakeholders are committed to developing pathways for effective biomarker qualification. Recently, the Center for Drug Evaluation and Research put forth biomarker qualification guidelines aiming at expediting and clarifying this process. Since the beginning of the Biomarker Qualification Program in 2007, only 6 biomarkers have been qualified though the program (1). Author Contributions: All authors confirmed they have contributed to the intellectual content ofthispaper and have met the following3 requirements: (a) significant contribution to the conception and design, acquisition of data, or analysis and interpretation ofdata; (b) drafting or revising the article for intellectual content; and (c) final approval of the published article.
ISSN:0009-9147
1530-8561
DOI:10.1373/clinchem.2018.286559