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
- June 2022: What’s New on ClinicalTrials.gov - On June 15, 2022, the below update was posted on ClinicalTrials.gov, What’s New section The British Medical Journal (BMJ) has published an article specifying the approaches to report master protocol study designs on ClinicalTrials.gov. A master protocol is a unified study design and operational aspect conducted with a collection of trials or substudies in patients … Continue reading "June 2022: What’s New on ClinicalTrials.gov"
- June 2022: What’s New on ClinicalTrials.gov - On June 09, 2022, the following updates were posted on the Clinicaltrials.gov What’s New section. The new FAQ for the deadline for submitting a good cause extension for prematurely terminated studies have been included and the information to be taken into consideration for registering expanded access records have been updated. A responsible party must submit … Continue reading "June 2022: What’s New on ClinicalTrials.gov"
- April 2022: Missing study records on Clinicaltrials.gov for orphan drugs approved by FDA– A TransperiMED Report - An article “No records found for 220 clinical trials of orphan drugs approved by the FDA” has been published on April 27, 2022, on TranspariMED. According to the article, around 63 orphan drugs were approved by the FDA between 2009 – 2019, which accounted for 422 clinical trials. A total of only 202 clinical trials … Continue reading "April 2022: Missing study records on Clinicaltrials.gov for orphan drugs approved by FDA– A TransperiMED Report"
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.