September 2021: What’s New on ClinicalTrials.gov

Below update was posted on ClinicalTrials.gov What’s New section on September 16, 2021:

Webinar on ClinicalTrials.gov Modernization: Join us on October 7, 2021, from 1:30 to 2:00 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts and information on the anticipated launch of beta ClinicalTrials.gov. A recording of the webinar and slides will be made available for those who cannot attend live.

August 2021: US Regulatory Update

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov

The FDA issued a Notice of Noncompliance on August 31, 2021, to Andrey Petrikovets, M.D. (responsible party) affiliated to University Hospitals Cleveland Medical Center, for failing to submit required summary results information to ClinicalTrials.gov. The company failed to update the study results for their applicable clinical trial (ACT) within 30 days after the first notice was issued. The company’s applicable clinical trial compared ICE-T postoperative multimodal pain regimen to the Standard regimen in patients undergoing same day vaginal pelvic reconstructive surgery.

The prenotice was issued on July 20, 2020, alerting Andrey Petrikovets to potential noncompliance with the requirement to submit clinical trial results. Although the trial’s results were made public in a medical journal, journal publication does not satisfy ClinicalTrials.gov disclosure requirements. On November 30, 2020, Andrey Petrikovets responded, stating that they were very busy with the “Covid surge” and were short staffed. FDA recognizes the unique circumstances that the pandemic presents, and believes they have provided ample opportunity to submit the required results information. The Notice of Noncompliance gives Andrey Petrikovets 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Andrey Pretrikovets’s violation, including additional civil money penalties if Andrey Petrikovets 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

July 2021: US Regulatory Update

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov 

The FDA issued a Notice of Noncompliance on July, 26th to Accuitis, Inc. for failing to submit required summary results information to ClinicalTrials.gov. The company also failed to update the primary completion date for their applicable clinical trial (ACT) within 30 days after the trial reached its primary completion date. The company’s applicable clinical trial evaluated the safety, efficacy, and tolerability of the drug ACCU-D1 in adult patients with moderate to severe acne rosacea.

The prenotice was issued on October 26, 2020, alerting Accuitis, Inc. to potential noncompliance with the requirement to submit clinical trial results. The trial’s results were recently made public in a medical journal, but journal publication does not satisfy FDA disclosure requirements. The Notice of Noncompliance gives Accuitis 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Accuitis’s violation, including additional civil money penalties if Accuitis 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 article: FDA threatens second company with fines over missing clinical trial results.

 

June 2021: What’s New on ClinicalTrials.gov PRS

The below update was posted on the What’s New section of ClinicalTrials.gov PRS Test, which will go live on June 27, 2021:

Late Results Problem Detection: The Late Results problem notification is now removed upon initial release of results rather than when results are posted. Similarly, the Incomplete Results problem notification is now removed upon the first release that includes all primary and secondary outcome measures.

May 2021: What’s New on ClinicalTrials.gov

The below update was posted on the What’s New section of ClinicalTrials.gov, on May 17, 2021:

Train-the-Trainer Workshop Application Period is Closed: The application period for the Results Database Train-the-Trainer Workshop for August 2021 is closed. For more information on the workshop go to Training Materials page.

May 2021: What’s New on ClinicalTrials.gov

The below updates were posted on the What’s New section of ClinicalTrials.gov, on May 11, 2021:

  • Downloading Content for Analysis: The ClinicalTrials.gov Beta API introduced in July 2019 is now the operational API. The Downloading Content for Analysis page has been updated to reflect this change, including links to the current XML schema and crosswalk linking data elements to corresponding API fields. Beginning on January 1, 2022, the previous API will no longer be supported.
  • An Additional Question Addressed in the Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19): An additional question (#6) and information from the NIH’s Director’s November 2020 Statement calling on researchers to swiftly share COVID-19 results has been added to the Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19) (PDF). Document is available on the Support Materials page.
  • Train the Trainer: The next Train-the-Trainer Workshop is scheduled for August 2021 and will be offered in an all-virtual format. Attendees must attend all five, two-hour live sessions on Tuesdays: August 3, August 10, August 17, August 24, and August 31. The application link is now available.

April 2021: US Regulatory Update

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov 

FDA issued a press release on April, 28th FDA Takes Action for Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov announcing that a Notice of Noncompliance which was sent to Acceleron Pharma  for failing to submit required summary results information to ClinicalTrials.gov. The company’s applicable clinical trial evaluated the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma.

The prenotice was issued on July 20, 2020, alerting Acceleron to potential noncompliance with the requirement to submit clinical trial results. The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period of issuance of this notice.

The Notice of Noncompliance has also been posted to the FDA’s website and information about the noncompliance will be 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.

March 2021: What’s New on ClinicalTrials.gov

The below update was posted on What’s New section of ClinicalTrials.gov with respect to ClinicalTrials.gov modernization, on March 09, 2021, in addition to the reiteration of the ClinicalTrials.gov PRS update:

Modernization Webinar Materials are now available. A recording of the February 18 webinar and slides describing the progress of the    modernization effort are added to the ClinicalTrials.gov Modernization page, including information on how to volunteer to provide user feedback.

March 2021: What’s New on ClinicalTrials.gov PRS

The below update was posted on the What’s New section of ClinicalTrials.gov PRS for March 04, 2021:

PRS Guided Tutorials
The PRS Guided Tutorials have new and updated content and features to make them more useful in response to feedback obtained through focus groups and survey responses over the past year. Enhancements include updated images and improved zoom functionality, additional study examples from materials developed for the behavioral sciences community, and revisions to the Introduction and tutorial content for added clarity and guidance. Two new sections have also been added: Quick Start Guides are designed to help users get the most from the tutorials, and the PDF Library has all of the tutorial content in a single place, readily available for download. Please note that audio narration has been removed.

February 2021: ClinicalTrials.gov Modernization Update

The following updates were communicated by NLM with respect to ClinicalTrials.gov modernization, on February 10, 2021:

Progress Towards a Modernized ClinicalTrials.gov
ClinicalTrials.gov acting director Rebecca Williams, PharmD, MPH, has authored a guest post on the National Library of Medicine Musings from the Mezzanine blog. Read the post to learn more about the progress to modernize ClinicalTrials.gov.

Webinar on ClinicalTrials.gov Modernization
Reminder to mark your calendars for an update on the ClinicalTrials.gov modernization effort on February 18, 2021, from 3 to 4 p.m. ET. Please register via the ClinicalTrials.gov
webinar registration page to attend the live event. A recording and the presentation slides will be posted after the webinar.