- ClinicalTrials.gov Statistics
- Who Uses ClinicalTrials.gov?
- Related Journal Publications
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry and results database."
ClinicalTrials.gov contains information about medical studies in human volunteers. Most of the records on ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access).
ClinicalTrials.gov does not contain information about all the clinical studies conducted in the United States because not all studies are required by law to be registered (for example, observational studies and trials that do not study a drug, biologic, or device). See FDAAA 801 Requirements for more information. However, the rate of study registration has increased over time as more policies and laws requiring registration have been enacted and as more sponsors and investigators have voluntarily registered their studies.
ClinicalTrials.gov was made available to the public on February 29, 2000, and the results database was released in September 2008. Once a study is registered on the site, it is not removed. The full history of the changes made to a record can be accessed by viewing the archival version of the record on the ClinicalTrials.gov archive.
An account of the development and expansion of ClinicalTrials.gov in response to changes in policies and laws is provided on the History, Policies, and Laws page.
Searching ClinicalTrials.gov does not require registration or personal identification. Because ClinicalTrials.gov is a Government Web site, it does not host or receive funding or advertising from commercial entities or display commercial content.
ClinicalTrials.gov received more than 207 million page views per month and 65,000 unique visitors daily (as of October 2015).
The following statistics are updated daily:
- ClinicalTrials.gov currently contains 221,361 study records. Of these, 51,156 studies are recruiting participants. Studies are sponsored by NIH, other Federal agencies, nonprofit organizations, and private industry.
- Studies listed in the database are conducted in all 50 States and in 192 countries.
For more statistics, charts, and maps related to ClinicalTrials.gov, see the Trends, Charts, and Maps page.
Who Uses ClinicalTrials.gov?
The main users of the site are patients, their families and caregivers, health care professionals, clinical researchers, and study record managers. They use ClinicalTrials.gov to:
- Search for open clinical studies (see a search for open studies)
- Browse studies by category or location (see the See Studies by Topic page)
- Search for studies that include results (see a search for studies with results)
Clinical researchers also use the site to stay current on developments in their field of interest, find collaborators, and identify unmet research needs. Other researchers may use the site to compile information on the research being conducted in a particular area to support the development of practice guidelines or reviews of completed research. In addition, clinical researchers or their study record managers must register their studies and submit study results to ClinicalTrials.gov using a Web-based system called the Protocol Registration and Results System. For more information, see:
- Why Should I Register and Submit Results?, How to Register Your Study, and How to Submit Your Results
- Brochure on registering and submitting results for sponsors and investigators
Related Journal Publications
- Zarin DA, Tse T, Sheehan J. The proposed rule for U.S. clinical trial registration and results submission. N Engl J Med. 2015 Jan 8;372(2):174-80. [Full Text]
- Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. N Engl J Med. 2011;364(9):852-60. [Full Text]
- Tse T, Williams RJ, Zarin DA. Reporting "basic results" in ClinicalTrials.gov. Chest. 2009;136(1):295-303. [Full Text]
- Zarin DA, Tse T. Moving towards transparency of clinical trials. Science. 2008;319(5868):1340-2. [Full Text (author manuscript)]
- Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA. 2007;297(19):2112-20.
- Zarin DA, Tse T, Ide NC. Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med. 2005 Dec 29;353(26):2779-87. [Full Text]
ClinicalTrials.gov Wins the Innovations in American Government Award
In 2004 ClinicalTrials.gov was cited by the Ash Center for Democratic Governance and Innovation at the Harvard Kennedy School as "a successful model for the creation and maintenance of a system that processes and presents large amounts of specialized information to a wide range of users" and was selected as one of five award winners. The Innovations in American Government Awards is the Nation's preeminent program devoted to recognizing and promoting excellence and creativity in the public sector. The program highlights exemplary models of government innovation and advances efforts to address the Nation's most pressing public concerns.
- Ash Center: ClinicalTrials.gov award page
- NIH Press Release: National Institutes of Health's "ClinicalTrials.gov" Web Site Wins Prestigious Award (July 28, 2004)
For more information, including interview requests, please contact the NLM Office of Communications and Public Liaison Director, Kathy Cravedi, at firstname.lastname@example.org or 301-496-6308 or the Deputy Director, Melanie Modlin, at email@example.com or 301-496-7771.
- ClinicalTrials.gov Background: The site's purpose, who supplies study record data, how to use the site
- History, Policies, and Laws: A timeline of events, laws, and policies affecting the creation and development of the site
- Selected Publications: Scholarly publications about ClinicalTrials.gov and clinical research
- Trends, Charts, and Maps: Featured statistics of general interest in narrative and graphic formats
- FDAAA 801 Requirements: Information on registration and results submission requirements under U.S. law for clinical researchers