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
- October 2021: What’s New on ClinicalTrials.gov - Below update was posted on ClinicalTrials.gov What’s New section on October 08, 2021: Train-the-Trainer Materials Available: The materials from the August 2021 Results Database Train-the-Trainer virtual workshop are now on the Training Materials page. The topics covered in the workshop included an Overview of the Clinical Trial Disclosure Landscape, a PRS System Overview, NIH Requirements for Clinical … Continue reading "October 2021: What’s New on ClinicalTrials.gov"
- October 2021: ClinicalTrials.gov Modernization Webinar Update - A Webinar on ClinicalTrials.gov Modernization took place on October 7, 2021. A summary report on the progress in ClinicalTrials.gov modernization effort from August 2019 to August 2021 is now published by the National Institutes of Health (NIH). This report gives detailed insight into the National Library of Medicine (NLM’s) approach to modernization, presents the Working … Continue reading "October 2021: ClinicalTrials.gov Modernization Webinar Update"
- September 2021: What’s New on ClinicalTrials.gov - Below update was posted on ClinicalTrials.gov What’s New section on September 16, 2021: Webinar on ClinicalTrials.gov Modernization: Join us on October 7, 2021, from 1:30 to 2:00 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts and information on the anticipated … Continue reading "September 2021: What’s New on ClinicalTrials.gov"