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Testing devices for the prevention and treatment of stroke and its complications

Bath, Philip M.W.; Brainin, Michael; Brown, Chloe; Campbell, Bruce; Davis, Stephen M.; Donnan, Geoffrey A.; Ford, Gary A.; Hacke, Werner; Iglesias, Cynthia; Lees, Kennedy R.; Pugh, Stacey S.; Saver, Jeffrey L.; Schellinger, Peter D.; Truelsen, Thomas

Authors

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

Michael Brainin

Chloe Brown

Bruce Campbell

Stephen M. Davis

Geoffrey A. Donnan

Gary A. Ford

Werner Hacke

Cynthia Iglesias

Kennedy R. Lees

Stacey S. Pugh

Jeffrey L. Saver

Peter D. Schellinger

Thomas Truelsen



Abstract

We are entering a challenging but exciting period when many new interventions may appear for stroke based on the use of devices. Hopefully these will lead to improved outcomes at a cost that can be afforded in most parts of the world. Nevertheless, it is vital that lessons are learnt from failures in the development of pharmacological interventions (and from some early device studies), including inadequate preclinical testing, suboptimal trial design and analysis, and underpowered studies. The device industry is far more disparate than that seen for pharmaceuticals; companies are very variable in size and experience in stroke, and are developing interventions across a wide range of stroke treatment and prevention. It is vital that companies work together where sales and marketing are not involved, including in understanding basic stroke mechanisms, prospective systematic reviews, and education of physicians. Where possible, industry and academics should also work closely together to ensure trials are designed to be relevant to patient care and outcomes. Additionally, regulation of the device industry lags behind that for pharmaceuticals, and it is critical that new interventions are shown to be safe and effective rather than just feasible. Phase IV postmarketing surveillance studies will also be needed to ensure that devices are safe when used in the ‘real-world’ and to pick up uncommon adverse events.

Citation

Bath, P. M., Brainin, M., Brown, C., Campbell, B., Davis, S. M., Donnan, G. A., …Truelsen, T. (in press). Testing devices for the prevention and treatment of stroke and its complications. International Journal of Stroke, 9(6), https://doi.org/10.1111/ijs.12302

Journal Article Type Article
Acceptance Date Apr 23, 2014
Online Publication Date Jul 17, 2014
Deposit Date Aug 17, 2016
Publicly Available Date Aug 17, 2016
Journal International Journal of Stroke
Print ISSN 1747-4930
Electronic ISSN 1747-4949
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 9
Issue 6
DOI https://doi.org/10.1111/ijs.12302
Keywords acute stroke therapy, clinical trial, device, prevention, stroke, treatment
Public URL http://eprints.nottingham.ac.uk/id/eprint/35872
Publisher URL http://onlinelibrary.wiley.com/doi/10.1111/ijs.12302/abstract
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf

Files

BATH Testing devices.pdf (3.9 Mb)
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





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