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.
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.
- 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
- Column headings were fixed so that the text wraps when a column is narrowed.
- 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.
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.
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:
- 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
- Expanded Access records
- Updated the Study Overview to show only relevant information
- Added links to related studies
- Added links to resources
- Expanded download file formats to include comma-separated values (.csv)
- Study record page
- Added ability to expand or collapse specific content in the study record
- Improved mobile design view
- Simplified the ability to select data fields for download from the search results or a study record
- Added a notice when study location information is not available
- Corrected accordion behavior in the mobile view
- 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.
FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov
The FDA issued a Notice of Noncompliance on April 15, 2022, to Ocugen for failing to submit required summary results information to ClinicalTrials.gov. The company’s applicable clinical trial evaluated the efficacy of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED).
The prenotice was issued on July 21, 2021, alerting Ocugen to potential noncompliance with the requirement to submit clinical trial results. The company failed to update the study results for their applicable clinical trial (ACT) within 30 days after the prenotice was issued. Upon receiving this notice of noncompliance, FDA provides Ocugen 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Ocugen’s violation, including additional civil money penalties and other regulatory action, such as injunction and/or criminal prosecution, without further notice, if Ocugen fails to submit the required information within the 30-day period.
The Notice of Noncompliance has been posted to the FDA’s website and information about the noncompliance has also been posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed, if any.
For more information, please refer to the Letter of noncompliance on the FDA Website: Non-Compliance Letter
On April 07, 2022, Clinicaltrials.gov posted an update on the FAQs for expanded access and all cause mortality and also included resources for NIH Data Sharing Policies.
New and Updated FAQs added on the Frequently Asked Questions (FAQs) page
The following are included under the section expanded access
The following was added under the section Results Information and Submission Deadlines
Resource for NIH Data Sharing Policies Added: The Support Materials page has been updated with information on the new NIH Scientific Data Sharing Website.
The below update was posted on the What’s New section of ClinicalTrials.gov PRS Test, which will be applicable from April 07, 2022:
Highlighted Differences on Release Record Screen
For PRS Administrators and Responsible Parties, the Release Record screen now includes a link to the “Highlighted Differences”. This link will open a new window which will show highlighted changes since the study was last reviewed or published.
An article “Where are the results for these 2,272 clinical trials involving children? ” was published on March 29, 2022 on TranspariMED.
This article, states that around 2,272 clinical trials involving children had not made their results public within three years of trial completion. On examining trial registries and academic journals, it was found that almost half (48%) of the clinical trial results could not be traced. The article also informs that academic trials (45%) involving children were much less likely make their results public within three years than trials sponsored by government (59%) or industry (61%). This article was originally published by the American Academy of Pediatrics – Early Discontinuation, Results Reporting, and Publication of Pediatric Clinical Trials.
According to the Final rule regulation for ClinicalTrials.gov, results information submission requirements must be submitted by the responsible party no later than 1 year after the primary completion date. The ClinicalTrials.gov registry also enables researchers to rapidly make results public without compromising their ability to later publish the same results in a medical journal.
As per the article, the study included all interventional pediatric trials, including trials run abroad by non-US sponsors. It excluded trials that involved both children and adults. The study analyzed a total of 4,657 pediatric trials registered on ClinicalTrials.gov from October 2007 that had been completed by March 2017. Of these, only 24% had reported results to the ClinicalTrials.gov registry, and 39% had published results in a peer-reviewed Journal, within three years of completion.
The article concluded that targeted efforts are needed to support trial completion and timely results dissemination toward strengthening evidence-based pediatric medicine.
More information can be found here
On March 08, 2022, ClinicalTrials.gov posted an update on the new features, improvements and bug fixes added on the Clinicaltrials.gov Beta website.
The key updates made in different section are as follows:
- Study record page:
- Made explanations available for suspended, withdrawn, and terminated studies
- Made acronyms available after the study title
- Provide Study Documents when they are part of the study record
- Added fields to the More Information section about the Individual Participant Data (IPD) Plan
- JSON download of search results now has an option to select all or de-select all of the most popular fields
- Release Notes page added so users will know what changes have been made to the website with each release
More information on the improvements, bug fixes, upcoming releases can be found at: Release Notes | Beta ClinicalTrials.gov
The seventh issue of CTIS Highlights was published on January 27, 2022. It provides a brief insight about the CTIS website, the transition from clinical trials regulation to CTIS, upcoming training courses that will assist future users in preparing for CTIS.
It provides an update about a new clinical trial website that will be launched by EMA on January 31, 2022, to support the launch of CTIS. The URL for the Clinical Trials website will be made available on the EMA website and social media channels. This public website would provide information on CTIS and would also allow users to search information for clinical trials authorized by CTIS.
It also provides an update on several upcoming end-user training courses that are scheduled from February 2022 to June 2022. EMA also provides extensive online training modules to assist users in preparing for CTIS. The “CTIS Sandbox-CTIS training environment” Survey is now reopened for the sponsor who did not respond in October 2021.
The incoming Clinical Trials Regulation on January 31, 2022, would pace the implementation of Accelerating Clinical Trials in the EU (ACT EU). The joint controllership arrangement has been established that describes the processing of personal data in CTIS, in accordance with the General Data Protection Regulation and EU Data Protection Regulation.
The newsletter also describes a query management process that receives queries from associations at the EU level. Sponsors would contact their national or EU-level associations with their queries and these associations would prioritize a list of questions for sharing with EMA, the European Commission, and the Member States.
The below update was posted on the What’s New section of ClinicalTrials.gov PRS Test, expected to go live on ClinicalTrials.gov PRS on February 2022:
PRS Beta Available
The first Beta PRS release consists of new workflow and portfolio management features to help data submitters save time, such as use of customizable display and multiple download options. A pre-recorded demonstration of this release is available.