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
- 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"
- April 2022: What’s New on ClinicalTrials.gov Beta - On April 27, 2022, ClinicalTrials.gov Beta website, Release notes section posted an update on the new features, improvements and bug fixes added. The key updates made in the different sections are as follows: Study record page Added MeSH terms and FDA drug and device information to the More Information section Added Study record dates just … Continue reading "April 2022: What’s New on ClinicalTrials.gov Beta"
- April 2022: What’s New on ClinicalTrials.gov - On April 07, 2022, Clinicaltrials.gov posted an update on the FAQs for expanded access and all cause mortality and also included resources for NIH Data Sharing Policies. New and Updated FAQs added on the Frequently Asked Questions (FAQs) page The following are included under the section expanded access What is expanded access? Who is required … Continue reading "April 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.