PRM51 From Clinical Trial to Real-World Evidence: A Systematic Approach to Identifying Data Sources for Observational Research

Edifici industrial de dos cossos de planta baixa i tres plantes pis acabades amb mansarda. Destaca el nombre i dimensions de les obertures que permeten una gran entrada de llum a l'interior i l'amplitud de les plantes diàfanes.Digitalitzat per Tecnodo

Preclinical Models of Wound Healing: Is Man the Model? Proceedings of the Wound Healing Society Symposium

SIGNIFICANCE: A review of therapeutic effects in preclinical and clinical studies suggests that concordance between large animal (pig=78%), small laboratory animal (53%) and in vitro (57%) results with those observed in humans is only partial. Pig models of wound healing provide major advantages over other animal models. Since the vast majority of wound-healing research is done in rodents and in vitro, the low concordance rate is a significant impediment to research that will have any clinical impact. CRITICAL ISSUES: To generate clinically relevant experimental data, hypothesis generation should begin, or at least involve human wound tissue samples. Such tissue could be used to test a predetermined hypothesis generated based on, say, murine data. Alternatively, such tissue could be analyzed using high-throughput cell biology techniques (e.g., genomics, proteomics, or metabolomics) to identify novel mechanisms involved in human wounds. Once the hypothesis has been formulated and confirmed using human samples, identification of these same mechanisms in animals represents a valid approach that could be used for more in-depth investigations and experimental manipulations not feasible with humans. FUTURE DIRECTIONS: This consensus statement issued by the Wound Healing Society symposium strongly encourages all wound researchers to involve human wound tissue validation studies to make their animal and cell biology studies more translationally and clinically significant