Optimizing the early phase development of new analgesics by human pain biomarkers.
Human pain biomarkers are based on standardized acute activation of pain pathways/mechanisms and quantitative assessment of the evoked responses. This approach can be applied to healthy volunteers, to pain patients, and before and after pharmacological interventions to help understanding and profile the mode of action (proof-of-concept) of new and existing analgesic compounds. Standardized stimuli of different modalities can be applied to different tissues (multimodal and multi-tissue) for profiling analgesic compounds with respect to modulation of pain transduction, transmission, specific mechanisms and processing. This approach substantiates which specific compounds may work in particular clinical pain conditions. Human pain biomarkers can be translational and may bridge animal findings in clinical pain conditions, which in turn can provide new possibilities for designing more successful clinical trials. Biomarker based proof-of-concept drug studies in either volunteers or selected patient populations provide inexpensive, fast and reliable mechanism-based information about dose-efficacy relationships. This is important information in the early drug development phase and for designing large expensive clinical trials.
Center for Sensory-Motor Interaction, Department of Health Sciences and Technology, Laboratory for Experimental Pain Research, Aalborg University, Fredrik Bajers Vej 7 D3, DK-9220, Aalborg, Denmark. LAN@hst.aau.dk
Lars
L
Arendt-Nielsen
Hans Christian
HC
Hoeck
D000700:Analgesics / Q000494:pharmacology*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D006801:Humans; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement / Q000379:methods* / Q000592:standards*; D017288:Pain Threshold; D012107:Research Design
D000700:Analgesics