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)||
|Registration and Results Requirements|
|Within 21 days of first patient enrollment|
|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|
Regulation effective since January 18, 2017
|Study Phase||2 to 4|
|When to Register||Within 21 days of the first subject enrollment|
|Timing of Registration||Prospective and Retrospective|
|Scope||Applicable clinical Trials (ACT) – Interventional Phase 2-4 clinical trials that are either investigational new drug (IND) or investigational device exemption (IDE) trials or conducted in the USA or study drug manufactured/exported from the USA|
|Registration Publicly Available||
Timeline for Disclosure
- January 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 January 26, 2023. The Study Design, Eligibility, and References modules, among others, have been added to the Protocol Section. Each module has new or updated onscreen guidance, slide-out drawers with additional help, and content specific to the type … Continue reading "January 2023: What’s New on ClinicalTrials.gov PRS Beta Test System"
- January 2023: What’s New on ClinicalTrials.gov - On January 31, 2023, 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: A new draft application programming interface (API) has been added on the Home page. This tool provides … Continue reading "January 2023: What’s New on ClinicalTrials.gov"
- December 2022: What’s New on ClinicalTrials.gov - On December 19, 2022, the below update was posted on ClinicalTrials.gov, What’s New section: ClinicalTrials.gov Beta Website: Prerecorded demonstration videos presenting features of PRS Beta and ClinicalTrials.gov Beta and highlighting changes from the classic sites are now available. New search features, Improvements and bug fixes are added to make the ClinicalTrials.gov Beta website more user-friendly. The key features include: Streamlined … Continue reading "December 2022: What’s New on ClinicalTrials.gov"