FDA perspective on objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia
Received 18 September 2009; accepted 22 September 2009. published online 09 November 2009.
The article by Conte et al.1 on behalf of the Society for Vascular Surgery (SVS) in this issue of the Journal of Vascular Surgery provides guidelines for improving the consistency and interpretability of clinical trials intended to evaluate treatment options for patients with critical limb ischemia (CLI). This article identifies a number of key challenges with conducting and comparing CLI trials, including the wide spectrum of clinical presentations that CLI encompasses, the use of disparate eligibility criteria and endpoint measurements, and logistical and economic considerations that can limit study initiation and completion. The authors propose definitions for a number of performance goals derived from historical surgical literature as a means of reducing the negative impact of these factors. The current editorial reviews aspects of this proposal from the perspective of the authors in terms of their understanding of the statutory obligations of the U.S. Food and Drug Administration (FDA) to regulate the marketing of cardiovascular devices based on valid scientific evidence.
Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Cardiovascular Devices, Silver Spring, Md
Reprint requests: Allison Kumar, BS, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Cardiovascular Devices, 10903 New Hampshire Ave., WO66-1270, Silver Spring, MD 20993
Competition of interest: none.
The views and opinions are those of the authors and do not necessarily reflect those of the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, or the Public Health Service.
The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.
ABSTRACT