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A service of the U.S. National Institutes of Health

A service of the U.S. National Institutes of Health. Module 1: Clinical Trials and Requirements for Registration and Results Reporting. What is a Clinical Study?. A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes.

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A service of the U.S. National Institutes of Health

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  1. A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting

  2. What is a Clinical Study? • A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes ClinicalTrials.gov Glossary of Common Site Terms [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/about-studies/glossary

  3. Two Types of Clinical Studies ClinicalTrials.gov Glossary of Common Site Terms [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/about-studies/glossary

  4. Clinical Trial Process Tse T, Zarin DA, Williams RJ, Ide NC. The Role and Importance of Clinical Trial Registries and Results Databases. In: Gallin JI, Ognibene FP, editors. Principles and Practice of Clinical Research. London: Academic Press; c2012. p. 171-181.

  5. What is ClinicalTrials.gov? ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); c2013. Available from: http://clinicaltrials.gov/

  6. Registration Requirements *Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) **International Committee of Medical Journal Editors (ICMJE) ClinicalTrials.gov Why Should I Register and Submit Results? [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/manage-recs/background

  7. Results Submission Requirements • Results of an applicable clinical trial must be submitted no later than 12 months after the completion date • Results information is submitted in a series of data tables with supporting notes. Results include: • Participant flow • Baseline characteristics • Outcome measures and statistical analyses • Adverse events ClinicalTrials.gov About the Results Database [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/about-site/results

  8. Levels of Transparency Zarin DA, Tse T. Moving Toward Transparency of Clinical Trials. Science. 2008 Mar 7;319(5868):1340-2. doi: 10.1126/science.1153632.

  9. Who Uses ClinicalTrials.gov?

  10. ClinicalTrials.gov Visitors by Role N = 2,216 Source: American Customer Satisfaction Index (ACSI) Online Consumer Survey; 4th Quarter 2012

  11. Patients and Families • ClinicalTrials.gov offers a reliable and generally comprehensive list of ongoing trials that people might consider enrolling in • Gives patients a centralized place to search by condition, location, and other trial characteristics

  12. About Clinical Studies ClinicalTrials.gov About Clinical Studies [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/about-studies

  13. Map of All Studies in ClinicalTrials.gov ClinicalTrials.gov See Studies on Map [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/search/map

  14. Clinical Researchers • ClinicalTrials.gov is a place to find information on ongoing and completed clinical trials that may not be published • It provides a place to find unique evidence for systematic reviews • Data in ClinicalTrials.gov can be downloaded and analyzed to reveal trends in the clinical research enterprise

  15. 1.5 Billion Page Views in FY2012

  16. Summary, Part 1 • A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes • Federal law (FDAAA) requires registration and results submission for certain trials. Other policies, such as that of the journal editors (ICMJE), also require registration of clinical trials

  17. Summary, Part 2 • The primary users of ClinicalTrials.gov are patients and the original purpose is to connect patients with studies • Clinical researchers can use ClinicalTrials.gov to find information about studies that may be unpublished • Librarians can raise awareness among clinical researchers that it is their responsibility to register and submit results in a timely manner to benefit all users of ClinicalTrials.gov

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