Biomarker Validation: Context and Complexities. Issue 3 (2019)

• Record Type: Journal Article
• Authors: McShane, Lisa M.
• Editors: Hey, Spencer Phillips
• Is Part Of: Journal of law, medicine & ethics. Volume 47:Issue 3(2019)
• Page Start: 388
• Page End: 392
• Publication Date: 2019
• Subjects: Medical laws and legislation -- United States -- Periodicals; Medical care -- Law and legislation -- United States -- Periodicals; Medical ethics -- Periodicals; Jurisprudence -- Periodicals; Legislation, Medical -- Periodicals; Legislation, Nursing -- Periodicals; Ethics -- Periodicals; Forensic Medicine -- Periodicals; Nursing -- Periodicals; Medicine -- Periodicals; Societies -- Periodicals; Medical care -- Law and legislation; Medical ethics; Medical laws and legislation; United States; Periodicals; 344.73041
• DOI: 10.1177/1073110519876169
• Languages: English
• ISSNs: 1073-1105

Abstract

Abstract : Validation of a biomarker-based medical product development tool or clinical test is an evidentiary process that must be tailored to the proposed use. Appropriate data and analyses are needed to demonstrate that the biomarker meets analytical and clinical performance criteria consistent with favorable benefit: risk balance.