Perspectives on Statistical Strategies for the Regulatory Biomarker Qualification Process
Open Access
- 26 May 2021
- journal article
- review article
- Published by Taylor & Francis in Biomarkers in Medicine
- Vol. 15 (9) , 669-684
Abstract
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 d...Keywords
Funding Information
- TKV qualification example (U18 FD 005320)
This publication has 11 references indexed in Scilit:
- Regulatory Experience of Qualifying Total Kidney Volume as a Prognostic Biomarker for Clinical Trial EnrichmentStatistics in Biopharmaceutical Research, 2019
- The FDA NIH Biomarkers, EndpointS, and other Tools (BEST) resource in neuro-oncologyNeuro-Oncology, 2017
- What evidence do we need for biomarker qualification?Science Translational Medicine, 2017
- Acute Kidney Injury and Urinary Biomarkers in Human Immunodeficiency Virus–Associated Cryptococcal MeningitisOpen Forum Infectious Diseases, 2017
- A Drug Development Tool for Trial Enrichment in Patients With Autosomal Dominant Polycystic Kidney DiseaseKidney International Reports, 2017
- Total Kidney Volume Is a Prognostic Biomarker of Renal Function Decline and Progression to End-Stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney DiseaseKidney International Reports, 2017
- Application of new acute kidney injury biomarkers in human randomized controlled trialsKidney International, 2016
- Biomarkers of acute kidney injury and associations with short- and long-term outcomesF1000Research, 2016
- Statistical evaluation of surrogate endpoints with examples from cancer clinical trialsBiometrical Journal, 2015
- Evaluation of the Relative Performance of 12 Urinary Biomarkers for Renal Safety Across 22 Rat Sensitivity and Specificity StudiesToxicological Sciences, 2013