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

• Record Type: Journal Article
• Authors: McShane, Lisa M.
• Other Names: Hey Spencer Phillips guest-editor.
• Is Part Of: Journal of law, medicine & ethics. Volume 47:Issue 3(2019)
• Page Start: 388
• Page End: 392
• Publication Date: 2019-09
• 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

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 bio-marker meets analytical and clinical performance criteria consistent with favorable benefit: risk balance.