Sumeet Subherwal1, Manesh R Patel2, Karen Chiswell1, Beth A Tidemann-Miller1, W Schuyler Jones1, Michael S Conte1, Christopher J White1, Deepak L Bhatt1, John R Laird1, William R Hiatt1, Asba Tasneem1, Robert M Califf1. 1. From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.). 2. From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.). manesh.patel@duke.edu.
Abstract
BACKGROUND: Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); until recently, however, it has not been possible to examine the entire clinical trial portfolio of studies for the treatment of PVD (both arterial and venous disease). METHODS AND RESULTS: We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower-extremity peripheral artery disease and acute stroke (35% and 24%, respectively), whereas most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients >65 years of age. Enrollment in at least 1 US site decreased from 51% of trials in 2007 to 41% in 2010. Compared with noncardiology disciplines, PVD trials were more likely to be double-blinded, to investigate the use of devices and procedures, and to have industry sponsorship and assumed funding source, and they were less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. CONCLUSIONS: PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.
BACKGROUND: Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); until recently, however, it has not been possible to examine the entire clinical trial portfolio of studies for the treatment of PVD (both arterial and venous disease). METHODS AND RESULTS: We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower-extremity peripheral artery disease and acute stroke (35% and 24%, respectively), whereas most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients >65 years of age. Enrollment in at least 1 US site decreased from 51% of trials in 2007 to 41% in 2010. Compared with noncardiology disciplines, PVD trials were more likely to be double-blinded, to investigate the use of devices and procedures, and to have industry sponsorship and assumed funding source, and they were less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. CONCLUSIONS: PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.
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