Clinical trials in peripheral vascular disease: pipeline and trial designs: an evaluation of the ClinicalTrials.gov database.
نویسندگان
چکیده
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.
منابع مشابه
Clinical Trials in Peripheral Vascular Disease : Pipeline and Trial Designs : An Evaluation of the ClinicalTrials . gov Database Running title
متن کامل
Effect of Heparin Administration during Coronary Angiography on Vascular or Peripheral Complications: A Single-Blind Randomized Controlled Clinical Trial
Background: Coronary angiography consists of the selective injection of contrast agents in coronary arteries. Optimal strategy for heparin administration during coronary angiography has yet to be determined. We assessed the effect of heparin administration during coronary angiography on vascular, hemorrhagic, and ischemic complications.Methods: Five hundred candiates for diagnostic coronary ang...
متن کاملAdaptive designs undertaken in clinical research: a review of registered clinical trials
Adaptive designs have the potential to improve efficiency in the evaluation of new medical treatments in comparison to traditional fixed sample size designs. However, they are still not widely used in practice in clinical research. Little research has been conducted to investigate what adaptive designs are being undertaken. This review highlights the current state of registered adaptive designs...
متن کاملBridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases.
BACKGROUND There has been tremendous progress over the last decade in the development of health products--drugs, vaccines, and diagnostics--for neglected diseases. There are now dozens of candidate products in the pipeline. PURPOSE Our purpose is to assess challenges that will arise in later-stage clinical development of these candidate health products and propose a strategy that would help b...
متن کاملDiagnosis, Prognosis and Treatment of Peripheral Vascular Disease in Patients with Diabetic Foot Ulcer: Adopted IWGDF Guidance
Introduction: Peripheral arterial disease (PAD) is common in diabetic patients, and about half of the patients with diabetic foot ulcers (DFU) have concomitant peripheral arterial disease (PAD). The purpose of this study was to select an appropriate and comprehensive clinical guide in the management of DFU. The part of the practical guide that pertains to this is based on three systematic revie...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Circulation
دوره 130 20 شماره
صفحات -
تاریخ انتشار 2014