Fact Sheet
ClinicalTrials.gov

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What is ClinicalTrials.gov?
ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with all NIH Institutes and the Food and Drug Administration (FDA).

How do I find ClinicalTrials.gov?
ClinicalTrials.gov is available on the World Wide Web from the NLM Home Page (http://www.nlm.nih.gov/) or directly at ClinicalTrials.gov (http://clinicaltrials.gov/).

What information is in ClinicalTrials.gov? Abstracts of Clinical Study Protocols that include the following information:

• summary of the purpose of the study
• recruiting status
• criteria for patient participation
• location of the trial and specific contact information

Additional Information that may help a patient decide whether to consider a particular trial:

• research study design
• phase of the trial
• disease or condition and drug or therapy under study

Links to Online Health Resources that help place clinical trials in the context of patients' overall medical care, including Medlineplus® and PubMed®.

Why has the National Institutes of Health (NIH) established ClinicalTrials.gov?
The ClinicalTrials.gov information resource was initiated as a result of the Food and Drug Administration Modernization Act of November 1997. The legislation requires the Department of Health and Human Services, through the NIH, to establish a registry of clinical trials for both federally and privately funded trials "of experimental treatments for serious or life-threatening diseases or conditions."

How are study protocols submitted to ClinicalTrials.gov?
The FDA Guidance Document (March 2002) (http://www.fda.gov/cder/guidance/4856fnl.htm) describes the submission criteria. The NLM has developed the Protocol Registration System (PRS), a Web-based tool for submitting information to ClinicalTrials.gov. Study sponsors or their representatives may register online to apply for a PRS account (http://prsinfo.clinicaltrials.gov/).

ClinicalTrials.gov facts

• Completely confidential. No registration or personal identification is required.
• Includes thousands of trials sponsored by the U.S. NIH, government agencies, the pharmaceutical industry, and universities, foundations and other organizations from around the world.
• Released February 29, 2000.

Need more information?
NLM's toll-free number is 1-888-FINDNLM (1-888-346-3656) 
NLM's e-mail address is custserv@nlm.nih.gov

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A complete list of NLM Fact Sheets is available at:
(alphabetical list) http://www.nlm.nih.gov/pubs/factsheets/factsheets.html
(subject list): http://www.nlm.nih.gov/pubs/factsheets/factsubj.html

Or write to:

FACT SHEETS
Office of Communications and Public Liaison
National Library of Medicine 
8600 Rockville Pike
Bethesda, Maryland 20894 

Phone: (301) 496-6308
Fax: (301) 496-4450
email: publicinfo@nlm.nih.gov

Last reviewed: 15 September 2009
Last updated: 15 September 2009
First published: 26 March 2003
Metadata| Permanence level: Permanent: Stable Content

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