There is increasing interest in the application of biomarkers and surrogate endpoints in healthy volunteer studies
Biomarkers provide pivotal information on efficacy, dose-response and time-effects of drugs.
ICON has worked extensively in this area, developing and validating models for investigating a range of therapeutic targets, as part of its own research and development efforts and in partnership with Sponsors. These techniques fall broadly into two categories:
Pharmacodynamic models of disease state
Use of healthy volunteer models has proven to be fast and reliable for determining if a drug has the necessary characteristics to be taken forward into more expensive patient trials. The dedicated Clinical Pharmacodynamics group at ICON has developed and validated a variety of pharmacodynamic models in a broad range of therapeutic areas including:
- Pain (acute and chronic)
- Cognitive Function
- Metabolic Function/Diabetes
- Sexual Dysfunction
Techniques for specific PD responses
When a protocol requires the inclusion of a specific technique that is out of the normal scope of a CPU, the PD group is responsible for identifying, validating and testing the equipment. A wide list of techniques is offered by ICON covering tests for sedation, CNS imaging, physiological assessments and mood assessments.