Clinical trials in peripheral vascular disease

Pipeline and trial designs: An evaluation of the ClinicalTrials.gov database

Sumeet Subherwal, Manesh R. Patel, Karen Chiswell, Beth A. Tidemann-Miller, W. Schuyler Jones, Michael S. Conte, Christopher J. White, Deepak L. Bhatt, John R. Laird, William R. Hiatt, Asba Tasneem, Robert M. Califf

Research output: Contribution to journalArticle

27 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1812-1819
Number of pages8
JournalCirculation
Volume130
Issue number20
DOIs
StatePublished - 2014

Fingerprint

Peripheral Vascular Diseases
Clinical Trials
Databases
Peripheral Arterial Disease
Embolism
Vascular Diseases
Venous Thrombosis
Lower Extremity
Industry
Stroke
Placebos
Drug Therapy
Equipment and Supplies
Lung

Keywords

  • Clinical trials as topic
  • Peripheral vascular diseases
  • Prevention and control
  • Registries

ASJC Scopus subject areas

  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Subherwal, S., Patel, M. R., Chiswell, K., Tidemann-Miller, B. A., Jones, W. S., Conte, M. S., ... Califf, R. M. (2014). Clinical trials in peripheral vascular disease: Pipeline and trial designs: An evaluation of the ClinicalTrials.gov database. Circulation, 130(20), 1812-1819. https://doi.org/10.1161/CIRCULATIONAHA.114.011021

Clinical trials in peripheral vascular disease : Pipeline and trial designs: An evaluation of the ClinicalTrials.gov database. / Subherwal, Sumeet; Patel, Manesh R.; Chiswell, Karen; Tidemann-Miller, Beth A.; Jones, W. Schuyler; Conte, Michael S.; White, Christopher J.; Bhatt, Deepak L.; Laird, John R.; Hiatt, William R.; Tasneem, Asba; Califf, Robert M.

In: Circulation, Vol. 130, No. 20, 2014, p. 1812-1819.

Research output: Contribution to journalArticle

Subherwal, S, Patel, MR, Chiswell, K, Tidemann-Miller, BA, Jones, WS, Conte, MS, White, CJ, Bhatt, DL, Laird, JR, Hiatt, WR, Tasneem, A & Califf, RM 2014, 'Clinical trials in peripheral vascular disease: Pipeline and trial designs: An evaluation of the ClinicalTrials.gov database', Circulation, vol. 130, no. 20, pp. 1812-1819. https://doi.org/10.1161/CIRCULATIONAHA.114.011021
Subherwal, Sumeet ; Patel, Manesh R. ; Chiswell, Karen ; Tidemann-Miller, Beth A. ; Jones, W. Schuyler ; Conte, Michael S. ; White, Christopher J. ; Bhatt, Deepak L. ; Laird, John R. ; Hiatt, William R. ; Tasneem, Asba ; Califf, Robert M. / Clinical trials in peripheral vascular disease : Pipeline and trial designs: An evaluation of the ClinicalTrials.gov database. In: Circulation. 2014 ; Vol. 130, No. 20. pp. 1812-1819.
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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.",
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