Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Media/Press Resources

Contents

Overview

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 all the clinical studies conducted in the United States because not all studies (for example, observational studies and trials that do not study a drug, biologic, or device) are required by law to be registered (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 changes made to a record can be accessed by viewing the archival version of the record on the ClinicalTrials.gov archive.

Read a complete account of the development and expansion of ClinicalTrials.gov in response to changes in policies and laws 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 Statistics

ClinicalTrials.gov receives more than 112 million page views per month and 57,000 unique visitors daily (as of July 2014).

The following statistics are updated nightly:

  • ClinicalTrials.gov currently contains 179,458 study records. Of these, 44,821 studies are recruiting participants. Studies are sponsored by NIH, other Federal agencies, nonprofit organizations, and private industries.
  • Studies listed in the database are conducted in all 50 States and in 187 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:

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:

Related Journal Publications

Awards

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.

Questions?

For more information including interview requests, please contact the NLM Office of Communications and Public Liaison Director, Kathy Cravedi, at cravedik@nlm.nih.gov or 301.496.6308, or Deputy Director, Melanie Modlin, at modlinm@nlm.nih.gov or 301.496.7771.

Learn More

This page last reviewed in September 2014