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 ClinicalTrials.gov Glossary of Common Site Terms [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from:

Two Types of Clinical Studies 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 Interventional Study (Clinical Trial) Participants identified as belonging to study groups are assessed for biomedical or health outcomes Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions Observational Study ClinicalTrials.gov Glossary of Common Site Terms [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from:

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

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

Registration Requirements Applicable clinical trials must submit required clinical trial information not later than 21 days after enrollment of the first participant U.S. Federal Law (FDAAA 801*) Requires trial registration as a condition for the publication of research results generated by a clinical trial Publication Policy (ICMJE**) *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:

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:

Levels of Transparency Zarin DA, Tse T. Moving Toward Transparency of Clinical Trials. Science Mar 7;319(5868): doi: /science

Who Uses ClinicalTrials.gov? ClinicalTrials.gov Patients and Families Librarians Scientists and Researchers

ClinicalTrials.gov Visitors by Role RolePercent Patient28% Scientist/Researcher18% Family/Friend14% Health Care Provider8% Other7% Clinical Trial Staff6% Clinical Research Support5% Student/Educator4% Medical Communications3% Librarian/Information Prof.2% IRB or Ethics<1% N = 2,216 Source: American Customer Satisfaction Index (ACSI) Online Consumer Survey; 4th Quarter 2012

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

About Clinical Studies ClinicalTrials.gov About Clinical Studies [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from:

Map of All Studies in ClinicalTrials.gov ClinicalTrials.gov See Studies on Map [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from:

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

1.5 Billion Page Views in FY2012

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

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