The United States of America (USA) clinical trials registry, ClinicalTrials.gov, is considered as a global platform for registering the clinical trials. It is not a World Health Organization (WHO) recognized primary registry. However, the clinical trials registered on this registry fulfill the criteria for publication of manuscript in an International Committee of Medical Journal Editors (ICMJE) accredited journal. In the USA, registration of protocols and submission of results is governed by the NIH Final Rule (42 CFR Part 11), which has been in effect since January 18, 2017. This regulation requires registration and results reporting for phase 2-4 interventional clinical trials.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| ClinicalTrials.gov | Country requiring/recommending ClinicalTrials.gov use | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 2-4) |
English |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| ClinicalTrials.gov | Registration |
Yes |
Within 21 days of first patient enrollment |
| Results |
Yes |
Primary Results - within one year of primary completion date (PCD); Subsequent Results - within one year of the last subject last visit for each secondary outcome measure (SOM); Final Results - within one year of the study completion date | |
Registry Updates
- March 2023: What’s New on ClinicalTrials.gov - On March 09, 2023, an update was posted on ClinicalTrials.gov, What’s New section, as follows: Virtual Webinar on ClinicalTrials.gov Modernization On April 25, 2023, from 12:30 to 3:00 pm Eastern Time, a webinar will take place providing an extensive update on the current Beta website and progress updates. Attendees will have the opportunity to hear … Continue reading "March 2023: What’s New on ClinicalTrials.gov"
- March 2023: ClinicalTrials.gov Beta Website Update - On March 08, 2023, an update was posted on the Release notes section of the ClinicalTrials.gov Beta website, which reads as follows: To enhance user-friendliness, the ClinicalTrials.gov Beta website has incorporated new features such as Table view, as well as improvements, and bug fixes. The key features include: The interventional and observational studies on ClinicalTrials.gov … Continue reading "March 2023: ClinicalTrials.gov Beta Website Update"
- February 2023: What’s New on ClinicalTrials.gov PRS Beta Test System - The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on February 09, 2023. The following updates have been made to the ClinicalTrials.gov PRS Beta test system. The oversight module is added to the protocol section. Expanded the help content in the study design module. Developed new design for error handling. … Continue reading "February 2023: What’s New on ClinicalTrials.gov PRS Beta Test System"
References
- ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies. ClinicalTrials.gov. https://prsinfo.clinicaltrials.gov/definitions.html. Published June 27, 2018. Accessed March 13, 2019.
- ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies. ClinicalTrials.gov. https://prsinfo.clinicaltrials.gov/results_definitions.html. Published June 27, 2018. Accessed March 13, 2019.
- Frequently Asked Questions – ClinicalTrials.gov. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/manage-recs/faq#fr_23. Published November 2018. Accessed March 13, 2019.