clinicaltrialsgov

is a Data Source.

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world, maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The registry contains information on over 400,000 studies covering a wide range of diseases and conditions, providing details about study design, locations, eligibility criteria, interventions, outcomes, and results. ClinicalTrials.gov serves as the primary registry for clinical trials required by the FDA Amendments Act and WHO International Clinical Trials Registry Platform (ICTRP).

Domains

clinical, health, public health, drug discovery, precision medicine, biomedical, translational

License

Public Domain

Homepage

clinicaltrialsgov

Repository

GitHub

Infores ID

infores:clinicaltrials

FAIRsharing ID

FAIRsharing.mewhad

Product Summary

Products

From this Resource
ID Name URL Category Format Description
clinicaltrialsgov.search ClinicalTrials.gov Search Portal search GraphicalInterface http Web-based interface for searching and...
clinicaltrialsgov.api ClinicalTrials.gov API api ProgrammingInterface http RESTful API providing programmatic ac...
clinicaltrialsgov.downloads ClinicalTrials.gov Data Downloads download-clinical-trial-data Product mixed Bulk downloads of all clinical trial ...
clinicaltrialsgov.aact AACT Database aact.ctti-clinicaltrials.org Product postgres Aggregate Analysis of ClinicalTrials....
clinicaltrialsgov.docs ClinicalTrials.gov Documentation about-site DocumentationProduct http Comprehensive documentation covering ...
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Details

ClinicalTrials.gov

Overview

ClinicalTrials.gov is a comprehensive database of clinical studies conducted in the United States and around the world. Maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH), it provides the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

The resource was established in 2000 in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA). The database was expanded in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA) to include more comprehensive trial registration data and basic results reporting. The system continues to evolve to improve transparency in clinical research and provide valuable information to researchers, healthcare providers, and patients.

Content and Coverage

Study Types

  • Interventional Studies: Trials testing new treatments, drugs, devices, or behavioral interventions
  • Observational Studies: Studies examining health outcomes in specific populations without intervention
  • Expanded Access: Investigational treatments available outside of clinical trials
  • Patient Registries: Collections of patient health information for specific diseases or conditions

Data Elements

Each clinical trial record includes:

  • Study identification and registration information
  • Study title and summary
  • Study design and methodology
  • Eligibility criteria (inclusion/exclusion)
  • Interventions and comparators
  • Outcome measures (primary and secondary)
  • Study locations and contact information
  • Study start and completion dates
  • Participant demographics
  • Results data (when available)
  • Adverse events
  • Publications and references

Coverage Statistics

  • 400,000+ registered clinical studies
  • 220+ countries represented
  • All 50 US states plus territories
  • Daily updates with new and modified records

Regulatory Context

ClinicalTrials.gov serves as the primary registry for:

  • FDA Amendments Act (FDAAA) Section 801 compliance
  • WHO International Clinical Trials Registry Platform (ICTRP)
  • International Committee of Medical Journal Editors (ICMJE) requirements
  • Support for regulatory compliance with trial registration and results reporting requirements

Data Access Methods

Web Interface

The primary search portal allows:

  • Advanced search with multiple filters
  • Geographic visualization of study locations
  • Export of search results
  • Study comparison tools
  • Linkage to published literature via PubMed

REST API

The ClinicalTrials.gov API provides:

  • Programmatic access to all trial records
  • JSON and CSV output formats
  • Field-level queries
  • Pagination for large result sets
  • Rate limiting: No authentication required for reasonable use

Bulk Downloads

Complete database exports available in:

  • XML format (pipe-delimited files)
  • JSON format
  • CSV format
  • Daily and monthly update files

AACT Database

The Aggregate Analysis of ClinicalTrials.gov (AACT) database:

  • Relational PostgreSQL database
  • Daily updates from ClinicalTrials.gov
  • Optimized for aggregate analysis and research
  • Free access with straightforward schema
  • Maintained by the Clinical Trials Transformation Initiative (CTTI)
  • Code repository: https://github.com/ctti-clinicaltrials/aact

Use Cases

  1. Patient Recruitment: Finding eligible clinical trials for specific conditions
  2. Research: Analyzing trends in clinical research and drug development
  3. Systematic Reviews: Identifying all trials for meta-analyses
  4. Regulatory Compliance: Meeting trial registration requirements
  5. Transparency: Public access to study designs and results
  6. Competitive Intelligence: Tracking clinical development pipelines
  7. Public Health: Monitoring research activity for specific diseases

Data Quality and Compliance

  • Study sponsors and investigators are responsible for data accuracy
  • Results must be submitted within one year of study completion (FDAAA requirement)
  • NLM performs quality control checks but does not independently verify all data
  • Records marked with data quality issues or non-compliance indicators

Information Resource ID

This resource has the Information Resource identifier: infores:clinicaltrials

Important Notes

  • Registration is not approval: Listing a study does not mean it has been evaluated by the US Federal Government
  • Results may be incomplete: Not all studies are required to submit results
  • Contact study sites: For participation, contact information is provided in each record
  • Updates: Records are maintained by study sponsors and may be updated throughout the study lifecycle

Is this information incorrect or incomplete? Request an update.

Created: May 28, 2025 | Last modified: February 20, 2026