ClinicalTrials.gov is 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 the manuscript in an International Committee of Medical Journal Editors (ICMJE) accredited journal. The 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. Phase 1 and observational trials can be registered voluntarily on clinicalTrials.gov.
| 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 (Phases 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 - On February 08, 2023, the below update was posted on ClinicalTrials.gov, What’s New section: Good Cause Extension (GCE) Request Process and Criteria. The Good Cause Extension Request Process and Criteria is a document intended to explain to responsible parties the process of submitting a good cause extension request to extend the deadline for submitting clinical trial … Continue reading "February 2023: What’s New on ClinicalTrials.gov"
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.