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Biomarker Validation: Context and Complexities
Journal of Law, Medicine and Ethics 47 (3):388-392 (2019)
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.Other Versions
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References found in this work
Challenges and Opportunities for Biomarker Validation.Spencer Phillips Hey, Elvira D'Andrea, Emily H. Jung, Frazer Tessema, Jing Luo, Bishal Gyawali & Aaron S. Kesselheim - 2019 - Journal of Law, Medicine and Ethics 47 (3):357-361.
Cochrane's Linked Data Project: How it Can Advance our Understanding of Surrogate Endpoints.Chris Mavergames, Deirdre Beecher, Lorne A. Becker, A. Last & A. Ali - 2019 - Journal of Law, Medicine and Ethics 47 (3):374-380.
Is Cancer Solvable? Towards Efficient and Ethical Biomedical Science.Jeff Shrager, Mark Shapiro & William Hoos - 2019 - Journal of Law, Medicine and Ethics 47 (3):362-368.
How Clinical Trial Data Sharing Platforms Can Advance the Study of Biomarkers.Rebecca Li & Ida Sim - 2019 - Journal of Law, Medicine and Ethics 47 (3):369-373.
Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.Spencer Phillips Hey, William B. Feldman, Emily H. Jung, Elvira D'Andrea & Aaron S. Kesselheim - 2019 - Journal of Law, Medicine and Ethics 47 (3):381-387.
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