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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.

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


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.

Citation

Busscher, H. J., Alt, V., Van Der Mei, H. C., Fagette, P. H., Zimmerli, W., Moriarty, T. F., …Grainger, D. W. (2019). A trans-atlantic perspective on stagnation in clinical translation of antimicrobial strategies for the control of biomaterial-implant associated infection. ACS Biomaterials Science and Engineering, 5(2), 402-406. https://doi.org/10.1021/acsbiomaterials.8b01071

Journal Article Type Article
Acceptance Date Dec 1, 2018
Online Publication Date Dec 2, 2018
Publication Date Feb 11, 2019
Deposit Date Nov 30, 2018
Publicly Available Date Jan 23, 2019
Journal ACS Biomaterials Science & Engineering
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
Public URL https://nottingham-repository.worktribe.com/output/1347102
Publisher URL https://pubs.acs.org/doi/10.1021/acsbiomaterials.8b01071

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