How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

<p>Abstract</p> <p>Background</p> <p>Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting...

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Main Authors: Tsutani Kiichiro, Sawata Hiroshi
Format: Article
Language:English
Published: BMC 2011-06-01
Series:BMC Research Notes
Online Access:http://www.biomedcentral.com/1756-0500/4/222
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author Tsutani Kiichiro
Sawata Hiroshi
author_facet Tsutani Kiichiro
Sawata Hiroshi
author_sort Tsutani Kiichiro
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases.</p> <p>Findings</p> <p>We searched for trials using clinicaltrials.gov (URL: <url>http://www.clinicaltrials.gov/</url>) using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test).</p> <p>Conclusions</p> <p>Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.</p>
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spelling doaj.art-a80b1504c74e49acb7af614e2b033b0d2022-12-21T20:55:53ZengBMCBMC Research Notes1756-05002011-06-014122210.1186/1756-0500-4-222How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?Tsutani KiichiroSawata Hiroshi<p>Abstract</p> <p>Background</p> <p>Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases.</p> <p>Findings</p> <p>We searched for trials using clinicaltrials.gov (URL: <url>http://www.clinicaltrials.gov/</url>) using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test).</p> <p>Conclusions</p> <p>Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.</p>http://www.biomedcentral.com/1756-0500/4/222
spellingShingle Tsutani Kiichiro
Sawata Hiroshi
How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?
BMC Research Notes
title How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?
title_full How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?
title_fullStr How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?
title_full_unstemmed How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?
title_short How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?
title_sort how can the evidence from global large scale clinical trials for cardiovascular diseases be improved
url http://www.biomedcentral.com/1756-0500/4/222
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