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A trans-atlantic perspective on stagnation in clinical translation of antimicrobial strategies for the control of biomaterial-implant associated infection

Busscher, Henk J.; Alt, Volker; Van Der Mei, Henny C.; Fagette, Paul H.; Zimmerli, Werner; Moriarty, T. Fintan; Parvizi, Javad; Schmidmaier, Gerhard; Raschke, Michael J.; Gehrke, Thorsten; Bayston, Roger; Baddour, Larry M.; Winterton, Lynn C.; Darouiche, Rabih O.; Grainger, David W.

Authors

Henk J. Busscher

Volker Alt

Henny C. Van Der Mei

Paul H. Fagette

Werner Zimmerli

T. Fintan Moriarty

Javad Parvizi

Gerhard Schmidmaier

Michael J. Raschke

Thorsten Gehrke

Roger Bayston

Larry M. Baddour

Lynn C. Winterton

Rabih O. Darouiche

David W. Grainger

Abstract

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 combination implants and devices. Improved dialogue between the various key players involved in the current translational blockade, which include patients, academicians and doctors, policymakers, regulatory agencies, manufacturers, and healthcare payers, is urgently needed.

Journal Article Type Article
Publication Date Feb 11, 2019
Electronic ISSN 2373-9878
Publisher American Chemical Society
Peer Reviewed Peer Reviewed
Volume 5
Issue 2
Pages 402-406
DOI https://doi.org/10.1021/acsbiomaterials.8b01071
Keywords biomaterial-associated infection; downward clinical translation; prosthesis; enrichment; benefit assessment; risk assessment; biomaterials; surface modification
Publisher URL https://pubs.acs.org/doi/10.1021/acsbiomaterials.8b01071

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