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.

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: 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.

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.

April 2022: What’s New on ClinicalTrials.gov

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.

March 2022: Sponsors Fail to Upload Pediatric Clinical Trials on ClinicalTrials.gov – A TransperiMED Report

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