Overview of ClinicalTrials.gov
Analyzing the Parkinson's disease clinical trial pipeline to facilitate patient collaboration in research.
ClinicalTrials.gov is an open access clinical study database launched in 2000 by the National Institutes of Health (NIH). Since PDTrialTracker.info tracks and analyzes Parkinson's disease clinical study data maintained in the ClinicalTrials.gov database, this page provides an overview of ClinicalTrials.gov for background on this valuable service that provides free access to medical research data for the benefit of all.
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.
Selected events, policies, and laws related to the development and expansion of ClinicalTrials.gov.1997: Congress Passes Law (FDAMA) Requiring Trial Registration
2000: NIH Releases ClinicalTrials.gov Web Site
2000–2004: FDA Issues Guidance for Industry Documents
2004: ClinicalTrials.gov Wins the Innovations in American Government Award
2005: International Committee of Medical Journal Editors Requires Trial Registration
2006: World Health Organization Establishes Trial Registration Policy
2007: Congress Passes Law (FDAAA) Expanding ClinicalTrials.gov Submission Requirements
2008: ClinicalTrials.gov Releases Results Database
2008: Declaration of Helsinki Revision Promotes Trial Registration and Results Dissemination
2009: Public Meeting Held at the National Institutes of Health
2013: European Medicines Agency Expands
Clinical Trial Database to Include Summary Results
2014: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 Issued for Public Comment
2014: NIH Draft Policy on Registration and Results Submission of NIH-Funded Clinical Trials Issued for Public Comment
2015: National Cancer Institute Issues Clinical Trial Access Policy
2016: Final NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information Issued