ClinicalTrials.gov

Anna RippleNational Library of Medicine

Bethesda, Maryland

MLA PresentationMay 2006

ClinicalTrials.gov Topics

1. International Committee of Medical Journal Editors (ICMJE) editorials regarding trial registration

2. Map of Locations functionality

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]

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ClinicalTrials.gov launched – April 2000• Paxil Settlement (GSK) – Aug 2004• ICMJE Statement #1 – Sept 2004• Vioxx Withdrawn (Merck) – Sept 2004• PhRMA Position Statement – Jan 2005• Fair Access to Clinical Trials (FACT) Act (S 470) – Feb 2005• WHO Advisory Group (Geneva) – Apr 2005•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

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

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

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

“ClinicalTrials.gov Identifier to be added to MEDLINE/PubMed Data” (6/23/2005)

(Identifier format: NCT12345678)

“ClinicalTrials.gov Scope Expanded” (8/08/05)

ICMJE-ClinicalTrials.gov Mapping

ClinicalTrials.gov Demo

http://clinicaltrials.gov

ClinicalTrials.gov Home page

ClinicalTrials.gov “What’s New”

ClinicalTrials.gov records with published results

PubMed citation of Trial results

PubMed record

LinkOut

LinkOut

LinkOut Display

ClinicalTrials.gov Record

LinkOut

ClinicalTrials.gov Record

PubMed Citation Format Display

Citation Display Format (cont’d)

ClinicalTrials.gov Record

ClinicalTrials.gov Record (cont’d)

ClinicalTrials.gov Record (cont’d)

Link back to PubMed citation

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Number of Records in ClinicalTrials.gov

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

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

ClinicalTrials.gov Search

Search Results

ClinicalTrials.gov Map of Locations

Map of Locations (cont’d)

Map of Locations (cont’d)

Studies ongoing in Europe

Listing/Browse by Map

ClinicalTrials.gov List by Map

Studies with locations in Arizona

ClinicalTrials.gov Topics covered

1. International Committee of Medical Journal Editors (ICMJE) editorials regarding trial registration (icmje.org)

2. Map of Locations functionality

ClinicalTrials.govhttp://clinicaltrials.gov

Anna RippleNational Library of Medicine

ripple@nlm.nih.gov

MLA PresentationMay 2006