1. ClinicalTrials.gov: A service of the U.S. National Institutes of Health This project has been funded in whole or in part with Federal funds from the National Library of Medicine, National Institutes of Health, Department of Health and Human Services, under Contract No. HHS-N-276-2011-00003-C with the University of Pittsburgh, Health Sciences Library System.

2. ClinicalTrials.gov Homepage

3. ClinicalTrials.gov 145,377 studies In all 50 states and in 185 countries Data as of May 16, 2013

4. Why Register Clinical Trials? Support ethical and scientific objectives of clinical research Required by journal editors for trial results to be eligible for publication Required by U.S. Law for most clinical trials of drugs and devices

5. Summary Protocol Information

6. Results The study results will be displayed in a tabular format that includes the following information: Participant flow Baseline characteristics Outcome measures and statistical analyses Adverse events Administrative information

7. Study Records Link to Publications (when available)

8. Clinical Trial Process Adapted from Figure 15-1; Principles and Practice of Clinical Research. Elsevier Inc.; 2012.

9. 25 -50% of trials remain unpublished several years after completion Find results faster in ClinicalTrials.gov Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross-sectional analysis. BMJ. 2012;344:d7292.

10. Learning About the Law

11. Which trials must submit results? Clinical trials of FDA-approved drugs, biologics, and devices At least one site in the United States Initiated after Sept 2007 or ongoing as of Dec 2007 (Excludes Phase I drug and small feasibility device studies) Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) For more information: http://www.clinicaltrials.gov/

12. Learn about Submitting Studies

13. Penalties for not submitting results 1.Notices of noncompliance 2.Civil monetary penalties (up to $10,000/day) 3.Withholding of NIH grant funds Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) For more information: http://www.clinicaltrials.gov/

14. Growth of Studies with Posted Results Data as of May 31, 2013

15. Sample Uses of ClinicalTrials.gov Access information about specific trial o Find trials for potential participants o Track progress and protocol changes o See results (if available) Assess available evidence relevant to a specific clinical topic Assess nature of current and past research Review methodologies used in clinical trials