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
- April 2021: US Regulatory Update - FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov FDA issued a press release on April, 28th FDA Takes Action for Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov announcing that a Notice of Noncompliance which was sent to Acceleron Pharma for failing to submit required summary results … Continue reading "April 2021: US Regulatory Update"
- March 2021: What’s New on ClinicalTrials.gov - The below update was posted on What’s New section of ClinicalTrials.gov with respect to ClinicalTrials.gov modernization, on March 09, 2021, in addition to the reiteration of the ClinicalTrials.gov PRS update: Modernization Webinar Materials are now available. A recording of the February 18 webinar and slides describing the progress of the modernization effort are added … Continue reading "March 2021: What’s New on ClinicalTrials.gov"
- March 2021: What’s New on ClinicalTrials.gov PRS - The below update was posted on the What’s New section of ClinicalTrials.gov PRS for March 04, 2021: PRS Guided Tutorials The PRS Guided Tutorials have new and updated content and features to make them more useful in response to feedback obtained through focus groups and survey responses over the past year. Enhancements include updated images … Continue reading "March 2021: What’s New on ClinicalTrials.gov PRS"