Category: ClinicalTrials.gov

March 2023: What’s New on ClinicalTrials.gov

On March 09, 2023, an update was posted on ClinicalTrials.gov, What’s New section, as follows:

Virtual Webinar on ClinicalTrials.gov Modernization

On April 25, 2023, from 12:30 to 3:00 pm Eastern Time, a webinar will take place providing an extensive update on the current Beta website and progress updates. Attendees will have the opportunity to hear from and interact with members of the ClinicalTrials.gov modernization team and other stakeholders via chat.

To attend the webinar, registration in advance can be done through the webinar registration page. The meeting will be recorded and the recording as well as presentation slides will be available on the ClinicalTrials.gov Modernization webpage following the event.

March 2023: ClinicalTrials.gov Beta Website Update

On March 08, 2023, an update was posted on the Release notes section of the ClinicalTrials.gov Beta website, which reads as follows:

To enhance user-friendliness, the ClinicalTrials.gov Beta website has incorporated new features such as Table view, as well as improvements, and bug fixes.

The key features include:

    • The interventional and observational studies on ClinicalTrials.gov Beta now feature a new Table View that organizes study information in a way that caters to the needs of data researchers and journal editors.
    • To provide more accurate search results, a new label has been added to study records in the Table View.
    • Users can conveniently access studies by including study hyperlinks in CSV downloads.

Additionally, ClinicalTrials.gov Beta will soon introduce a feature that allows users to view record history and compare versions.

For more detailed information on these updates, please visit the Release Notes section of the Beta ClinicalTrials.gov website.

February 2023: What’s New on ClinicalTrials.gov

On February 08, 2023, the below update was posted on ClinicalTrials.gov, What’s New section:

Good Cause Extension (GCE) Request Process and Criteria.

The Good Cause Extension Request Process and Criteria is a document intended to explain to responsible parties the process of submitting a good cause extension request to extend the deadline for submitting clinical trial results information to ClinicalTrials.gov and the information necessary for the National Institutes of Health (NIH) to evaluate and provide a decision for the GCE requests.

New and Updated FAQs are available to clarify the Good Cause Extension Request Process and Criteria.

    • New FAQs:

The same update was posted on Clinicaltrials.gov PRS Test, which will go live on February 15, 2023:

The ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies document has been updated to reflect edits made to the following data fields in the Delayed Results section.

    • Appeal Justification
    • Requested Submission Date (Day now required)
    • Explanation

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:

Moreover, the tabular view of the study record will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta 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 Homepage to enhance search experience
    • Provision to ‘Add All Filters’ or ‘Reset to Default’ can be accessed by the  Advanced filter dropdown
    • The record history tab has been included in the study records to view a study record’s history of changes. The elements in the study record versions that have changes are highlighted.
    • The dates have been reformatted  from month, day, year (Month DD, YYYY) to year, month, day (YYYY-MM-DD) format.

Moreover, the draft version of the new application programming interface (API) to support the beta website will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

December 2022: What’s New on ClinicalTrials.gov

On December 07, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

Webinar on ClinicalTrials.gov Modernization and Beta Website Progress

The recording and slides for the ClinicalTrials.gov Modernization and Beta Website Progress webinar conducted on October 27, 2022, have been added to the ClinicalTrials.gov Modernization page. The webinar featured an update on the modernization effort and a demonstration of the ClinicalTrials.gov Beta and Protocol Registration and Results System (PRS) Beta websites.

Additionally, the Report that presents an update on the ClinicalTrials.gov Beta and PRS Beta websites, future modernization activities, and more, is accessible.

November 2022: What’s New on ClinicalTrials.gov

On November 17, 2022, 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:

    • In addition to expanded tabular view of search results, the card view of search results is also added.
    • Users can also select and reorder the columns displayed onscreen.
    • Printer-friendly layouts for selected study records have  been included
    • Navigation and accessibility for both the desktop and mobile versions of the website have been enhanced

Moreover, the feature for ‘Study record history’ will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

October 2022: What’s New on ClinicalTrials.gov

On October 06, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

Webinar on ClinicalTrials.gov Modernization and Beta Website Progress

The webinar will be held on October 27, 2022, from 1.00 to 2.00 pm Eastern Time. It will provide an update on the progress of the modernization effort and an overview of the Beta ClinicalTrials.gov website and Protocol Registration and Results System (PRS) Beta. Advance registration can be done on the Webinar registration page.  A recording of the event will be made available for those who cannot attend the live event.

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 by the general public.

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 of search results, new features, improvements and bug fixes are added to the ClinicalTrials.gov Beta website.

Moreover, the feature for ‘Table view of the study record’ will be coming soon. Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

FAQ Update

  • Under FDAAA 801,  results submission is not required for a non Applicable Clinical Trial (for example, a phase 1 trial studying an FDA-regulated investigational new drug). If a responsible party chooses to submit results for such a trial voluntarily, the Voluntary Submissions (PDF) provision of FDAAA 801 may apply.

Additionally, under the Voluntary Submissions (PDF) provision, a responsible party who submits results for such non-applicable clinical trial must submit complete clinical trial results information and must also submit results for each Applicable Clinical Trial that is required to be submitted to FDA for the same use studied.

More information on the FAQ can be found here.