Biomarkers in Clinical Trials: a Central Laboratory perspective

by Dr. Edwin Janssen, Eurofins Global Central Laboratory, EdwinJanssen@eurofins.com

Pharmaceutical Research and Development has shifted its focus towards biomarker-mediated drug development that is aimed at preventing late stage diagnosis of unsuccessful drugs. As the use of novel biomarkers has become an integral part of the decision-making process in drug development, these biomarkers require detailed data to demonstrate the validity of their application.

A clear understanding of how the biomarker assay will be used during drug development is pivotal for allowing critical decision-making. This requires efficient coordination and clear communication between the translational and clinical drug development teams on one hand, and the test laboratory on the other hand. From a regulatory perspective, the translational and/or clinical drug development teams should be aware that the applied biomarker requires rigorous analytical assay validation in order to understand analytical limitations and, hence, inference of the correct conclusions. Depending on the purpose, the rigour of data documentation, record keeping and reporting, might need to be similar to that of methods for Drug PK support. As such, the purpose of the biomarker assay should be clearly defined, including expectations for application in clinical trials.

For use in drug development, biomarker assays (laboratory tests) are predominantly used to facilitate therapeutic and regulatory decision-making. Furthermore, supportive biomarker data may or may not be required for drug submission. Therefore a selected biomarker assay might require more rigorous assay validation than what is done for the "routine" laboratory tests. When a biomarker test is developed and validated for exploratory purposes, additional effort might be required to "upgrade" the assay for approval purposes.

The support by the Central Laboratory of many clinical studies with a broad variety of biomarker applications has become valuable in creating an environment for rational decision-making on drug development. By clearly informing sponsors about the type of biomarkers being used and its potential analytical limitations, clinical laboratories have become a cornerstone in the drug development arena and are instrumental in accelerating drugs to market.

For more information, visit centrallab.eurofins.com