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

Getting to Know ClinicalTrials

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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. - PowerPoint PPT Presentation

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Page 1: Getting to Know ClinicalTrials

Getting to Know ClinicalTrials.gov

David Greenebaum

GaIN Fall Membership Meeting

November 7, 2012

Page 2: Getting to Know ClinicalTrials

ClinicalTrials.gov

Registry of clinical studies Database of results

Maintained by NLM & NIH Information provided & updated by studies’

sponsors/principal investigators

Page 3: Getting to Know ClinicalTrials

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

Page 4: Getting to Know ClinicalTrials

Number of studies registered

Page 5: Getting to Know ClinicalTrials

Studies with results posted

Page 6: Getting to Know ClinicalTrials

Basic search

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Page 7: Getting to Know ClinicalTrials

Advanced search

Page 8: Getting to Know ClinicalTrials

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

Page 9: Getting to Know ClinicalTrials

Search results

Page 10: Getting to Know ClinicalTrials

Study record

Page 11: Getting to Know ClinicalTrials

Study Record: Full Text View

Purpose Eligibility Contacts and location More information

Page 12: Getting to Know ClinicalTrials

Study Record: Tabular View

Tracking information Descriptive information Recruitment information Administrative information

Page 13: Getting to Know ClinicalTrials

Study record: results

Participant flow Baseline characteristics Outcome measures and statistical analyses Adverse events Administrative information

Page 14: Getting to Know ClinicalTrials

Other neat tricks

Search PubMed for study results by NCT number

Download batches of content for analysis Display & save XML data via URL

parameters