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Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database: Pipeline and Trial Designs: An Evaluation of the Clin...
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| Zeitschriftentitel: | Circulation |
|---|---|
| Personen und Körperschaften: | , , , , , , , , , , , |
| In: | Circulation, 130, 2014, 20, S. 1812-1819 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
Ovid Technologies (Wolters Kluwer Health)
|
| Schlagwörter: |
| author_facet |
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. 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. |
|---|---|
| author |
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. |
| spellingShingle |
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. Circulation Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database Physiology (medical) Cardiology and Cardiovascular Medicine |
| author_sort |
subherwal, sumeet |
| spelling |
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. 0009-7322 1524-4539 Ovid Technologies (Wolters Kluwer Health) Physiology (medical) Cardiology and Cardiovascular Medicine http://dx.doi.org/10.1161/circulationaha.114.011021 <jats:sec> <jats:title>Background—</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and Results—</jats:title> <jats:p> We examined interventional trials registered in <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link> 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. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p> PVD studies represent a small group of trials registered in <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link> , 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. </jats:p> </jats:sec> Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database Circulation |
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10.1161/circulationaha.114.011021 |
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Biologie Medizin |
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Ovid Technologies (Wolters Kluwer Health), 2014 |
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Circulation |
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| title_sub |
Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title |
Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_unstemmed |
Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_full |
Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_fullStr |
Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_full_unstemmed |
Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_short |
Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_sort |
clinical trials in peripheral vascular disease : pipeline and trial designs: an evaluation of the clinicaltrials.gov database |
| topic |
Physiology (medical) Cardiology and Cardiovascular Medicine |
| url |
http://dx.doi.org/10.1161/circulationaha.114.011021 |
| publishDate |
2014 |
| physical |
1812-1819 |
| description |
<jats:sec>
<jats:title>Background—</jats:title>
<jats:p>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).</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Methods and Results—</jats:title>
<jats:p>
We examined interventional trials registered in
<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link>
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.
</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Conclusions—</jats:title>
<jats:p>
PVD studies represent a small group of trials registered in
<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link>
, 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.
</jats:p>
</jats:sec> |
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| author | 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. |
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| description | <jats:sec> <jats:title>Background—</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and Results—</jats:title> <jats:p> We examined interventional trials registered in <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link> 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. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p> PVD studies represent a small group of trials registered in <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link> , 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. </jats:p> </jats:sec> |
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| spelling | 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. 0009-7322 1524-4539 Ovid Technologies (Wolters Kluwer Health) Physiology (medical) Cardiology and Cardiovascular Medicine http://dx.doi.org/10.1161/circulationaha.114.011021 <jats:sec> <jats:title>Background—</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and Results—</jats:title> <jats:p> We examined interventional trials registered in <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link> 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. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p> PVD studies represent a small group of trials registered in <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link> , 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. </jats:p> </jats:sec> Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database Circulation |
| spellingShingle | 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., Circulation, Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database, Physiology (medical), Cardiology and Cardiovascular Medicine |
| title | Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_full | Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_fullStr | Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_full_unstemmed | Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_short | Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_sort | clinical trials in peripheral vascular disease : pipeline and trial designs: an evaluation of the clinicaltrials.gov database |
| title_sub | Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| title_unstemmed | Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database |
| topic | Physiology (medical), Cardiology and Cardiovascular Medicine |
| url | http://dx.doi.org/10.1161/circulationaha.114.011021 |