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
- September 2022: What’s New on ClinicalTrials.gov - On September 26, 2022, the following update was posted on the ClinicalTrials.gov What’s New section: A Plain Language checklist for Lay Brief Summaries was added to the support materials under Data Element Definitions, Templates, and Checklists section. This checklist identifies plain language best practices to help investigators write brief summaries that can be easily understood … Continue reading "September 2022: What’s New on ClinicalTrials.gov"
- August 2022: What’s New on ClinicalTrials.gov - On August 23, 2022, the below update was posted on ClinicalTrials.gov What’s New section, regarding the updates made to the ClinicalTrials.gov Beta website and clarification on the FAQ related to the requirement on submitting results for a Non-applicable Clinical Trial. ClinicalTrials.gov Beta Website: In addition to improved search for clinical studies and a tabular view … Continue reading "August 2022: What’s New on ClinicalTrials.gov"
- July 2022: What’s New on ClinicalTrials.gov PRS Beta - The below update was posted on the What’s New section of ClinicalTrials.gov PRS test system on July 14, 2022. Two new record list views in PRS beta, the Planning View and the Public Site View, are now accessible for PRS administrators in the PRS.