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.
The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on November 10, 2022:
Updates have been made to the PRS Test system to include two modules in the Protocol Section. These redesigned modules include on-demand help tips and guidance to make the data elements more understandable.
The key features include:
- Users can create a new record and edit the Study Identification and Study Description modules of the Protocol Section.
- More accessible and understandable help content for protocol data elements have been added.
- Users can now access modules in any order they choose once the record has been created.
Detailed information on the updates can be found at here
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.
On September 29, 2022, the following update was posted on the What’s New section of the ClinicalTrials.gov PRS test system:
A checklist and template have been added as help documents to create a brief lay summary for the Study Description section.
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.
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.
- 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.
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.
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.
- 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
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
- Accessibility (508 compliance) was improved across PRS Beta site
- 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.
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
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.