ClinicalTrials.gov modernization: What’s new and how to get help

ClinicalTrials.gov.

Graphic courtesy of the National Library of Medicine; originally created for the "Musings from the Mezzanine" blog.

Published March 20, 2024

Print

To keep research teams informed of the latest updates to ClinicalTrials.gov, the University at Buffalo Clinical and Translational Science Institute (CTSI) will be providing news about the ClinicalTrials.gov website and online database of clinical research studies and results information throughout the year. Recent issues of Translational Spotlight highlighted the importance of compliance and, in the newsletter's "Research Roundtable" section, helpful FAQs. More is on the way, starting with an exploration of recent modernization efforts by ClinicalTrials.gov Protocol Registration and Results System Administrators Lynn Jagodzinski, CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi, CTSI Quality Assurance Specialist.

ClinicalTrials.gov was launched in 2000 by National Institutes of Health (NIH) and its National Library of Medicine (NLM). To accommodate the subsequent expansion of ClinicalTrials.gov, a ClinicalTrials.gov modernization process is underway for both the ClinicalTrials.gov website and the accompanying Protocol Registration and Results System (PRS).

Concurrent with the classic version of PRS, the modernized, Beta version has been available since January 2023. PRS users have been able to switch between the modernized and classic versions without losing any information or updates made in either version.

Highlights of the modernized website

The modernized website introduces a number of new features including a homepage showing new “Search” features; the addition of a “More Filters” section to the search page; the “Search Results” page showing card view and additional filters; and the “Study Overview” record page showing tabs.

Modernized CT.gov.

Pam Anderson, Associate Director, Clinical Research Office, has been using the modernized site and calls it “more user-friendly, with cleaner design.” She says the search features have been improved, making it easier to find studies with specific criteria.

“Search results are presented in a very informative and transparent manner,” Anderson adds. “In general, I think ClinicalTrials.gov has evolved. It is a great resource for anyone who is interested in research being conducted around the world.” 

What’s new in the PRS Beta version?

Modernized CT.gov.

Enhancements to various sections of the PRS have already been made or are in progress. For example, in the PRS Beta Record List, users can reorder columns, save views, filter data in all columns (not just a select few), and send emails directly from the Record List. In the Protocol Section, there is more immediate access to information about data elements and navigation of the section is improved, e.g., the ability to add information to modules in any order. The Record Summary view of the Beta version also includes enhanced navigation and organization to facilitate ease of study record review.

Modernization timeline

The classic version of the PRS will remain available until the modernized PRS is fully updated and functional. New features of the PRS are released periodically, with retirement of the classic version not expected before mid-2025.  While the development of the modernized PRS continues, users are encouraged to explore the system and become familiar with it.

User feedback

ClinicalTrials.gov and PRS user engagement is crucial to the modernization efforts, as user feedback has helped and continues to inform further improvements. 

Modernized CT.gov.

Users are encouraged to provide feedback and leave comments in the PRS Beta version by clicking the “Contact ClinicalTrials.gov” button or the yellow “Feedback” button. Users are also encouraged to provide their email address to be potentially contacted by the modernization team for opportunities to provide additional feedback.

Modernized CT.gov.

Users can also offer feedback regarding the website or the PRS by signing up via a form provided by NIH/NLM and to be contacted for further feedback and communication.

For updates regarding the ClinicalTrials.gov modernization, visit ClinicalTrials.gov Modernization and/or sign up to receive the NLM newsletter, Hot Off the PRS, via email.

How to get ClinicalTrials.gov help at UB

For UB assistance with ClinicalTrials.gov registration and reporting requirements, contact the UB ClinicalTrials.gov team (UBClinicalTrialsgov@buffalo.edu) or ClinicalTrials.gov PRS Administrators Lynn Jagodzinski (lynnjago@buffalo.edu), CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi (uj@buffalo.edu), CTSI Quality Assurance Specialist.