clinicaltrials.gov results reporting, unique evidence, and the role of medical librarians scr...
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ClinicalTrials.ClinicalTrials.govgov
Results Reporting, Unique Evidence, and the Role of Medical Librarians
SCR CONNECTionsMarch 19, 2014
What is a clinical trial?What is a clinical trial?
Requirements for Requirements for registration & resultsregistration & results
• “FDAAA 801”o Section 801 of the Food and Drug Administration Amendments Act
• Trials initiated after September 27, 2007 or ongoing as of December 26, 2007
• Drugs, biological products or devices subject to Food and Drug Administration (FDA) regulation
• ICMJEo International Committee of Medical Journal Editors requires registration
of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication.
o Encourages posting of clinical trial results in clinical trial registries but does not require it.
It’s all about It’s all about transparencytransparency
Lifecycle of a clinical Lifecycle of a clinical trialtrial
What is What is ClinicalTrials.govClinicalTrials.gov??
Searching Searching ClinicalTrials.govClinicalTrials.gov
The Librarian’s RoleThe Librarian’s Role
Questions?Questions?
800-338-7657
Karen VargasOutreach and Evaluation [email protected]
This project has been funded in whole or in part with Federal funds from the National Library of Medicine, National Institutes of Health, under Contract No. HHSN-276-2011-00007-C with the
Houston Academy of Medicine-Texas Medical Center Library.
CreditsCredits• Slide 2: Movie still: Young Frankenstein, picture of
laboratory• Slide 8: “Librarian Accessing PDQ.” A librarian at
the National Library of Medicine (NLM) is using an IBM computer to access National Cancer Institute’s PDQ. This work has been released into the public domain by its author, Bill Branson (Photographer).
• Slide 9: Armadillo librarian drawing by Karen Hyde, used by permission