clinicaltrials.gov anna ripple national library of medicine bethesda, maryland mla presentation may...
TRANSCRIPT
![Page 1: ClinicalTrials.gov Anna Ripple National Library of Medicine Bethesda, Maryland MLA Presentation May 2006](https://reader036.vdocuments.mx/reader036/viewer/2022062320/56649d925503460f94a79170/html5/thumbnails/1.jpg)
ClinicalTrials.gov
Anna RippleNational Library of Medicine
Bethesda, Maryland
MLA PresentationMay 2006
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ClinicalTrials.gov Topics
1. International Committee of Medical Journal Editors (ICMJE) editorials regarding trial registration
2. Map of Locations functionality
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Recent Headlines
• “Hiding the Data on Drug Trials” [NYT, 6/1/05]
• “Drug giants fail to name compounds in trial database” [Nature, 6/1/05]
• “Despite Vow, Drug Makers Still Withhold Clinical Information” [NYT, 5/31/05]
• “Journal editor blasts drug makers” [AP, 5/24/05]
• “Pfizer Reveals Study Linking Celebrex to Heart Risks” [Globe, 2/1/05]
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Timeline
• FDAMA legislation passed – Nov 1997• ClinicalTrials.gov launched – April 2000• Paxil Settlement (GSK) – Aug 2004• ICMJE Statement #1 – Sept 2004• Vioxx Withdrawn (Merck) – Sept 2004• PhRMA Position Statement – Jan 2005• Fair Access to Clinical Trials (FACT) Act (S 470) – Feb 2005• WHO Advisory Group (Geneva) – Apr 2005• ICMJE Statement #2 - May 2005• IOM Working Group – June 2005• FACT Act (HR 3196) – June 2005
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Who is the ICMJE?
• International Committee of Medical Journal Editors
• Leading medical journals including– JAMA– New England Journal of Medicine– The Lancet– Annals of Internal Medicine
• ICMJE editorial policies adopted by over 600 medical journals around the world
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ICMJE Editorials International Committee of Medical Journal Editors
• September 2004
• May 2005
• Research studies must be registered in a trial registry database as a condition of publication
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October 2004 Policy Changeat ClinicalTrials.gov
• ClinicalTrials.gov– Meets ICMJE requirements
• Any trial accepted if– IRB approval– Conforms with regulations of health authority
• Trials may be registered by– Sponsors, principal investigators– Governmental or international agencies
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“ClinicalTrials.gov Identifier to be added to MEDLINE/PubMed Data” (6/23/2005)
(Identifier format: NCT12345678)
“ClinicalTrials.gov Scope Expanded” (8/08/05)
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ICMJE-ClinicalTrials.gov Mapping
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ClinicalTrials.gov Demo
http://clinicaltrials.gov
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ClinicalTrials.gov Home page
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ClinicalTrials.gov “What’s New”
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ClinicalTrials.gov records with published results
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PubMed citation of Trial results
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PubMed record
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LinkOut
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LinkOut
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LinkOut Display
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ClinicalTrials.gov Record
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LinkOut
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ClinicalTrials.gov Record
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PubMed Citation Format Display
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Citation Display Format (cont’d)
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ClinicalTrials.gov Record
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ClinicalTrials.gov Record (cont’d)
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ClinicalTrials.gov Record (cont’d)
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Link back to PubMed citation
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0
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8,000
10,000
12,000
14,000
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18,000
20,000
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24,000
26,000
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30,000
Number of Records in ClinicalTrials.gov
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ICMJE Summary
• Considerable interest in trial registration
• ICMJE builds on FDAMA 113– Broadens scope: more types of interventions
& conditions– Introduces new use for registries– Increases incentive/awareness for registration
• Closer to comprehensive registration
• Evolution of ClinicalTrials.gov
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2. Map of Locations functionality
• Click on the "Map of locations" button on the Search Results page. Locations are displayed in three ways:
• Map of 50 states and the District of Columbia - click on a state to display studies with locations in that state
• Map of the world - click on a country/region to display studies with locations there
• Location information for text browsers (below the maps) - click on a location name
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ClinicalTrials.gov Search
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Search Results
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ClinicalTrials.gov Map of Locations
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Map of Locations (cont’d)
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Map of Locations (cont’d)
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Studies ongoing in Europe
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Listing/Browse by Map
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ClinicalTrials.gov List by Map
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Studies with locations in Arizona
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ClinicalTrials.gov Topics covered
1. International Committee of Medical Journal Editors (ICMJE) editorials regarding trial registration (icmje.org)
2. Map of Locations functionality
![Page 41: ClinicalTrials.gov Anna Ripple National Library of Medicine Bethesda, Maryland MLA Presentation May 2006](https://reader036.vdocuments.mx/reader036/viewer/2022062320/56649d925503460f94a79170/html5/thumbnails/41.jpg)
ClinicalTrials.govhttp://clinicaltrials.gov
Anna RippleNational Library of Medicine
MLA PresentationMay 2006