Clinical Testing

Biomarkers for Clinical testing

An important requirement for making efficient clinical development phase decisions  is the identification of mechanism-related markers of drug action (pharmacological biomarkers), or alternatively of disease-related markers which indicate an effect of the drug upon the actual disease (disease biomarkers).

In most therapeutic areas, the ideal marker in early clinical development  is a pharmacological biomarker which relates drug levels delivered to the desired pharmacological effect.  These are often measured in volunteer / non-patient subjects.  Examples of this are statins and cholesterol levels, insulin and blood sugar levels etc. Disease biomarkers are frequently used when mechanism-related biomarkers are not available, but may not be useful until the patient phases of clinical development.  Imaging techniques such as CAT (Computerised Axial Tomography) , MRI (Magnetic Resonance Imaging) etc ae often used to define disease based biomarkers. PET (Positron Emission Tomography) can be used to image the distribution of the drug in vivo.

At this point the lengthy process of Clinical Development can begin.