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Getting to Know ClinicalTrials

Getting to Know ClinicalTrials.gov. David Greenebaum GaIN Fall Membership Meeting November 7, 2012. ClinicalTrials.gov. Registry of clinical studies Database of results Maintained by NLM & NIH Information provided & updated by studies’ sponsors/principal investigators.

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Getting to Know ClinicalTrials

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  1. Getting to Know ClinicalTrials.gov David Greenebaum GaIN Fall Membership Meeting November 7, 2012

  2. ClinicalTrials.gov • Registry of clinical studies • Database of results • Maintained by NLM & NIH • Information provided & updated by studies’ sponsors/principal investigators

  3. History of ClinicalTrials.gov • Food and Drug Administration Modernization Act of 1997 (FDAMA) • Registry: February 2000 • Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 801 • Results database: September 2008

  4. Number of studies registered

  5. Studies with results posted

  6. Basic search

  7. Advanced search

  8. Other ways to find studies • Browse by topic • Conditions, Rare Diseases, Drug Interventions, Dietary Supplements, Sponsor/Collaborators, Locations • Alphabetical or category listing for each • View on a map

  9. Search results

  10. Study record

  11. Study Record: Full Text View • Purpose • Eligibility • Contacts and location • More information

  12. Study Record: Tabular View • Tracking information • Descriptive information • Recruitment information • Administrative information

  13. Study record: results • Participant flow • Baseline characteristics • Outcome measures and statistical analyses • Adverse events • Administrative information

  14. Other neat tricks • Search PubMed for study results by NCT number • Download batches of content for analysis • Display & save XML data via URL parameters

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