A Trans-Atlantic Perspective on Stagnation in ClinicalTranslation of Antimicrobial Strategies for the Control of Biomaterial-Implant-AssociatedInfection

摘要

Current regulatory requirements impede clinical translation and market introduction of many new antimicrobial combination implants and devices, causing unnecessary patient suffering, doctor frustration, and costs to healthcare payers. Regulatory requirements of antimicrobial combination implants and devices should be thoroughly revisited and their approval allowed based on enrichment of benefit demonstrations from high-risk patient groups and populations or device components to facilitate their clinical translation. Biomaterial implant and devices equipped with antimicrobial strategies and approved based on enrichment claims should be mandatorily enrolled in global registry studies supervised by regulatory agencies for a minimum five-year period or until statistically validated evidence for noninferiority or superiority of claims is demonstrated. With these recommendations, this trans-Atlantic consortium of academicians and clinicians takes its responsibility to actively seek to relieve the factors that stagnate downward clinical translation and availability of antimicrobial combinationimplants and devices. Improved dialogue between the various key playersinvolved in the current translational blockade, which include patients,academicians and doctors, policymakers, regulatory agencies, manufacturers,and healthcare payers, is urgently needed.