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.

July 2022: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on July 06, 2022, which will be available on ClinicalTrials.gov PRS Beta by late July, 2022.

The following updates and improvements were made in the different section of the PRS Beta test system.

Release Notes
    • The Release Notes can now be shared without logging in to PRS Beta
    • Release Notes are now visible on a separate page. Use the back button to return to the Record List Page
Record List Page
    • A banner was added to address users with more than 250 records
      • It explains that up to 250 records can be viewed in PRS Beta
      • It provides guidance for viewing more than 250 records
Record List – Columns and Filters
    • The Planning View and Public Site View have been added
      • These views are only visible to users with Administrator access.
      • These views can be customized, filtered, sorted, and exported just like the Default View
      • Newly included columns can be filtered using a search window
    • The Group column has been added to the Default View for users with Administrator access
Improvements
Record List Page
    • A “View” link and a “Locked” link have been added to the View Record column
    • The View Record column has been removed from the Customize Columns menu and is now a permanent fixture on the left-hand side of the Record List
General
    • Accessibility (508 compliance) was improved across PRS Beta site
Help Content
    • Content was updated in “About PRS Beta”
      • A summarized update on the Planning view and Public view along with other features have been included in the “About PRS Beta” section

A notification about the ClinicalTrials.gov PRS Beta test update was also published on the ClinicalTrials.gov PRS test system.

June 2022: What’s New on ClinicalTrials.gov

On June 15, 2022, the below update was posted on ClinicalTrials.gov, What’s New section

The British Medical Journal (BMJ) has published an article specifying the approaches to report master protocol study designs on ClinicalTrials.gov.

A master protocol is a unified study design and operational aspect conducted with a collection of trials or substudies in patients having same or different diseases and that employ one or multiple drugs to treat them. It helps achieve better coordination than can be achieved in single trials designed and conducted independently.

This article proposes reporting each master protocol research programs (MPRPs) substudy in a separate study record to allow for meaningful descriptions of each substudy and to better support the transparency and accountability. Other factors that require further consideration include coordinating the registration and results reporting of MPRPs, supporting the identification of MPRP related records, and harmonizing trial registries worldwide

Other Publications on ClinicalTrials.gov can be found here: Selected publications

June 2022: EU PAS Update

On June 14, 2022, the following update was posted on the EU PAS, News section.

A list of metadata describing real-world data sources and studies has been published on the EMA website, to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.

Real-world data are observational data stored in repositories such electronic health records and disease registries. Making use of these data sources can improve the evidence available to support benefit-risk decisions and facilitate getting better medicines to patients.

This metadata list will feed into two future EU catalogues on real-world data sources and studies:

Setting up a catalogue of data sources and enhancing the catalogue of studies aims to improve transparency with regard to observational studies, enhanced discoverability of studies and data sources, and contribute to increasing the ability to judge the evidentiary value of studies when used to investigate the use, safety and effectiveness of medicinal products. It also helps regulators, researchers and pharmaceutical companies identify studies and data sources suitable to address research questions, based on the so-called ‘FAIR’ (findable, accessible, interoperable and reusable) data principles.

June 2022: What’s New on ClinicalTrials.gov

On June 09, 2022, the following updates were posted on the  Clinicaltrials.gov What’s New section.

The new FAQ for the deadline for submitting a good cause extension for prematurely terminated studies have been included and the information to be taken into consideration for registering expanded access records have been updated.

A responsible party must submit results information no later than one year after the primary completion date unless the responsible party has submitted a certification of delay, a request for an extension for good cause, or a request for a waiver of the requirements for submission of results information.

The standard results information submission deadline is one year after the actual Primary Completion Date. The termination date does not impact the actual Primary Completion Date or the standard results information submission deadline.

A good cause extension request submitted on or after the standard results information submission deadline date, would be late and would not be accepted, regardless of when the decision to terminate the trial was made.

More information can be found here: FAQ

Detailed considerations for registering expanded access records can be found here.

May 2022: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the What’s New section of ClinicalTrials.gov PRS Beta test system, which will be available on ClinicalTrials.gov PRS Beta by late May, 2022:

The following updates, improvements, and bug fixes were made in the different section of the PRS Beta test system

Record List Page
    • The release version number was added to the top of the page.
    • A loading indicator was added to track the progress of a loading page.
    • A pop-up window was added to the Contact ClinicalTrials.gov button to provide other options for finding answers to questions and getting help with using PRS Beta.
Record List – Columns and Filters
    • The filter display was adjusted so that when you filter one column, all the filter options for the remaining columns can also be seen.
    • The ability to select multiple filter options for one column was added.
    • A column was added that shows which documents, if any, have been added to a study record.
    • An alert was added that displays when the system can’t process a search request.
    • An About menu was added that includes links to the About PRS Beta page and the release notes.
Improvements
Record List Page
    • The welcome banner on PRS Beta was replaced with a pop-up banner that you can click on to close.
    • A redesigned product icon was added.
    • The labels in the page header were updated to make it easier to know which view is currently displayed (e.g., default view, saved view).
Record List – Columns and Filters
    • The filtering for columns with names was updated to make searching easier
      • Pick lists were replaced with search fields.
      • A scrollable list of possible search results was added below search windows.
      • An autocomplete feature was added that narrows the list of search options as you type.
Help Content
    • Tooltips were added for each column heading in the Customize Columns menu to explain the information found there.
    • The About PRS Beta page was updated to include descriptions of the features currently available in PRS Beta.
Style and Visual Changes

Various changes were made to improve the way the site looks. These include:

    • Saved Views menu — Changes to the pop-up window that appears when you select “Save Current View As…”
    • Record List page — Adjusted the view for different screen sizes
    • Record List column headings and filters — Added boldface to column headings and changed the font colors of filters to aid navigation and improve readability
    • Record List columns — Added highlighting to columns when sorting is applied
    • Various buttons — Adjusted the spacing
Bug Fixes
    • Column headings were fixed so that the text wraps when a column is narrowed.
Coming Soon
    • Two new views: Planning View and Public Site View

A notification about the ClinicalTrials.gov PRS Beta test update was also published on the ClinicalTrials.gov PRS test system.

April 2022: Missing study records on Clinicaltrials.gov for orphan drugs approved by FDA– A TransperiMED Report

An article “No records found for 220 clinical trials of orphan drugs approved by the FDA” has been published on April 27, 2022, on TranspariMED.

According to the article, around 63 orphan drugs were approved by the FDA between 2009 – 2019, which accounted for 422 clinical trials.  A total of only 202 clinical trials could be located on ClinicalTrials.gov while 220 study records could not be traced. The study further focused on comparing data elements such as enrolment and study phase. It was observed that the enrolment data did not match for 30% of cases and the study phase data matched only for 75% cases.

The study team also stated that there could be various reasons why a trial could not be found on ClinicalTrials.gov, including that some studies may have run before ClinicalTrials.gov was established, some were Phase 1 trials that were not required to be registered until Final rule, some trials may remain unregistered in the US and some matches of studies on ClinicalTrials.gov may not have been identified, although such a match did exist.

The original article can be accessed here.

 

 

 

 

 

 

 

April 2022: What’s New on ClinicalTrials.gov Beta

On April 27, 2022, ClinicalTrials.gov Beta website, Release notes section posted an update on the new features, improvements and bug fixes added.

The key updates made in the different sections are as follows:

    1. Study record page
      • Added MeSH terms and FDA drug and device information to the More Information section
      • Added Study record dates just above the Study Overview
      • Added FDAAA 801 Violations information
      • Provided information when a study does not meet the FDA clinical device criteria
      • Added information to the results tab explaining why a user may not see study results
    2. Expanded Access records
      • Updated the Study Overview to show only relevant information
      • Added links to related studies
      • Added links to resources
    3. Expanded download file formats to include comma-separated values (.csv)

Improvements

    1. Study record page
      • Added ability to expand or collapse specific content in the study record
      • Improved mobile design view
    2. Simplified the ability to select data fields for download from the search results or a study record

Bugs fixed

    1. Added a notice when study location information is not available
    2. Corrected accordion behavior in the mobile view
    3. Repaired glossary links missing in mobile view

Additionally, the feature for ‘Advanced search’ will be coming soon.

More information on previous improvements, bug fixes, and upcoming releases can be found at Release Notes | Beta ClinicalTrials.gov.