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Editorial
. 2001 Jul 13;2(4):160-164.
doi: 10.1186/cvm-2-4-160.

Organizing the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): National Institutes of Health, Health Care Financing Administration, and industry funding

Robert W Hobson 2nd  1 , Virginia J Howard, Thomas G Brott, George Howard, Gary S Roubin, Robert DG Ferguson; For the CREST Executive Committee
Affiliations
Editorial

Organizing the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): National Institutes of Health, Health Care Financing Administration, and industry funding

Robert W Hobson 2nd et al. Curr Control Trials Cardiovasc Med. .

Abstract

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is a prospective, randomized, multicenter clinical trial of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) as prevention for stroke in patients with symptomatic stenosis greater than or equal to 50%. CREST is sponsored by the US National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health (NIH), with additional support by a device manufacturer, and will provide data to the US Food and Drug Administration (FDA) for evaluation of a stent device. Because of budget constraints for CREST, Health Care Financing Administration (HCFA) reimbursement for hospital costs incurred by CREST patients will be essential. The involvement of academic scientists, industry, and three separate government agencies (NIH, FDA, HCFA) has presented many challenges in conducting the trial. A review of the pathways followed to meet these challenges may be helpful to others seeking to facilitate sharing of the costs and burdens of conducting innovative clinical research.

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Figures

Figure 1
Figure 1
CREST organizational structure.
See this image and copyright information in PMC

References

    1. Hobson RW., II CREST (Carotid Revascularization Endarterectomy versus Stent Trial): background, design, and current status. Semin Vasc Surg. 2000;13:139–143. - PubMed
    1. FDA Notice to NIH grantees/contractors regarding letters or notices from the Food and Drug Administration (FDA). NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-053.html September 22, 2000.
    1. Howard G, Shelton BJ, Brott TG, Baker EA, White R, Kuntz RE, Hobson RW, II, Marler JR, for the CREST investigators Parallel hypothesis testing for science and industry in a large randomized clinical trial. Stroke. 2000;32:328.
    1. NIH NIH policy for data and safety monitoring. NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html June 10, 1998.
    1. NIH Further guidance on a data and safety monitoring for phase I and phase II trials. NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html June 5, 2000.

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