1. ClinicalTrials.gov Results Reporting, Unique Evidence, and the Role of Medical Librarians SCR CONNECTions March 19, 2014

2. What is a clinical trial?

3. Requirements for registration & 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 ICMJE o 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.

4. It’s all about transparency

5. Lifecycle of a clinical trial Update Registry Initial Results Reporting Register at Clinical Trials.gov Final Results Reporting Data Analysis IRB Approval & Initiate Study Conduct Study & Amend Protocols Complete Study

6. What is ClinicalTrials.gov?

7. Searching ClinicalTrials.gov

8. The Librarian’s Role

9. Questions? 800-338-7657 Karen Vargas Outreach and Evaluation Coordinator karen.vargas@exch.library.tmc.edu 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.

10. Credits 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