Perspectives on statistical strategies for the regulatory biomarker qualification process
| Autor: | Sue Jane Wang, Suzanne Hendrix, Klaus Romero, Aloka Chakravarty, John-Michael Sauer, Samuel P. Dickson, Lisa M. McShane, Robin Mogg |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
safety enrichment Drug Industry Process (engineering) diagnosis risk/benefit Clinical Biochemistry Health Care Sector Context (language use) context of use 01 natural sciences Biomarkers Pharmacological 010104 statistics & probability 03 medical and health sciences Drug Discovery Medicine Humans 0101 mathematics qualification validation Models Statistical business.industry United States Food and Drug Administration Biochemistry (medical) Additional research United States 030104 developmental biology Risk analysis (engineering) Pharmaceutical Preparations Medical product Perspective Biomarker (medicine) prognosis analysis plan business statistical |
| Zdroj: | Biomarkers in Medicine |
| ISSN: | 1752-0371 1752-0363 |
| Popis: | Qualification of a biomarker for use in a medical product development program requires a statistical strategy that aligns available evidence with the proposed context of use (COU), identifies any data gaps to be filled and plans any additional research required to support the qualification. Accumulating, interpreting and analyzing available data is outlined, step-by-step, illustrated by a qualified enrichment biomarker example and a safety biomarker in the process of qualification. The detailed steps aid requestors seeking qualification of biomarkers, allowing them to organize the available evidence and identify potential gaps. This provides a statistical perspective for assessing evidence that parallels clinical considerations and is intended to guide the overall evaluation of evidentiary criteria to support a specific biomarker COU. |
| Databáze: | OpenAIRE |
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