A biomarker, or biological marker, is a substance used as an indicator of a biological state. It is a characteristic that can be objectively measured and evaluated as an indicator of specific processes.
A biomarker can indicate a change that correlates with the risk or progression of a disease. Biomarkers can usually be detected and measured in parts of the body like the blood or other tissue. They may indicate either normal or diseased processes in the body.
For example, body temperature is a well-known biomarker for fever. Cholesterol values are a biomarker and also a risk indicator for coronary and vascular disease. It is also well known that blood sugar levels are a biomarker for diabetes.
In his article, “Biomarkers –Making the Appropriate Selection for Clinical Trials” a CECON consultant outlines the challenges in ensuring the appropriate biomarkers are chosen for clinical trials. Understanding these challenges and the many variables involved may add insight in legal cases involving pharmaceuticals.
Look for future articles discussing different ways biomarkers can be used in drug development and how the various testing factors that, if not carefully monitored, can lead to misleading results.
The author of the articles referenced is a Pharma consultant in The CECON Group network and has extensive experience in regulatory statistics in both clinical and preclinical areas. For 25 years, he was a statistical reviewer, supervisor, and manager in the Center for Drug Evaluation and Research (CDER) of the FDA. His expertise includes drug quality, stability, clinical trials, and data integrity. Click here to read more about this regulatory statistician consultant and expert witness