Henk J. Busscher
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
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., Parvizi, J., Schmidmaier, G., Raschke, M. J., Gehrke, T., Bayston, R., Baddour, L. M., Winterton, L. C., Darouiche, R. O., & 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 |
Contract Date | Nov 30, 2018 |
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A Trans-Atlantic Perspective on Stagnation in Clinical Translation of Antimicrobial Strategies for the Control of Biomaterial-Implant-Associated Infection
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