1. ClinicalTrials.gov Anna Ripple National Library of Medicine Bethesda, Maryland MLA Presentation May 2006

2. ClinicalTrials.gov Topics 1. International Committee of Medical Journal Editors (ICMJE) editorials regarding trial registration 2. Map of Locations functionality

3. 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]

4. 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1997 ClinicalTrials.gov launched – April 2000 Paxil Settlement (GSK) – Aug 2004 ICMJE Statement #1 – Sept 2004 Vioxx Withdrawn (Merck) – Sept 2004 PhRMA Position Statement – Jan 2005 Fair Access to Clinical Trials (FACT) Act (S 470) – Feb 2005 WHO Advisory Group (Geneva) – Apr 2005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

5. 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

6. 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

7. October 2004 Policy Change at 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

8. “ClinicalTrials.gov Identifier to be added to MEDLINE/PubMed Data” (6/23/2005) (Identifier format: NCT12345678) “ClinicalTrials.gov Scope Expanded” (8/08/05)

9. ICMJE-ClinicalTrials.gov Mapping

10. ClinicalTrials.gov Demo http://clinicaltrials.gov

11. ClinicalTrials.gov Home page

12. ClinicalTrials.gov “What’s New”

13. ClinicalTrials.gov records with published results

14. PubMed citation of Trial results

15. PubMed record

16. LinkOut

18. LinkOut Display

19. ClinicalTrials.gov Record

20. LinkOut

21. ClinicalTrials.gov Record

22. PubMed Citation Format Display

23. Citation Display Format (cont’d)

24. ClinicalTrials.gov Record

25. ClinicalTrials.gov Record (cont’d)

27. Link back to PubMed citation

28. Number of Records in ClinicalTrials.gov

29. 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

30. 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

31. ClinicalTrials.gov Search

32. Search Results

33. ClinicalTrials.gov Map of Locations

34. Map of Locations (cont’d)

36. Studies ongoing in Europe

37. Listing/Browse by Map

38. ClinicalTrials.gov List by Map

39. Studies with locations in Arizona

40. ClinicalTrials.gov Topics covered 1. International Committee of Medical Journal Editors (ICMJE) editorials regarding trial registration (icmje.org) 2. Map of Locations functionality

41. ClinicalTrials.gov http://clinicaltrials.gov Anna Ripple National Library of Medicine ripple@nlm.nih.gov MLA Presentation May 2006