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
- November 2022: What’s New on ClinicalTrials.gov - On November 17, 2022, the below update was posted on ClinicalTrials.gov, What’s New section: ClinicalTrials.gov Beta Website: New search features, Improvements and bug fixes are added to make the ClinicalTrials.gov Beta website more user-friendly. The key features include: In addition to expanded tabular view of search results, the card view of search results is also … Continue reading "November 2022: What’s New on ClinicalTrials.gov"
- October 2022: What’s New on ClinicalTrials.gov - On October 06, 2022, the below update was posted on ClinicalTrials.gov, What’s New section: Webinar on ClinicalTrials.gov Modernization and Beta Website Progress The webinar will be held on October 27, 2022, from 1.00 to 2.00 pm Eastern Time. It will provide an update on the progress of the modernization effort and an overview of the … Continue reading "October 2022: What’s New on ClinicalTrials.gov"
- September 2022: What’s New on ClinicalTrials.gov - On September 26, 2022, the following update was posted on the ClinicalTrials.gov What’s New section: A Plain Language checklist for Lay Brief Summaries was added to the support materials under Data Element Definitions, Templates, and Checklists section. This checklist identifies plain language best practices to help investigators write brief summaries that can be easily understood … Continue reading "September 2022: 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.