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.
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
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.
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.
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.
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.
The following update has been posted on ClinicalTrials.gov What’s New section on January 25, 2021:
- Webinar on ClinicalTrials.gov Modernization: Join us on February 18, 2021, from 3 to 4 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, the RFI, and ways to share your feedback. A recording of the webinar and slides will be made available for those who cannot attend live.
- New and Updated FAQs to Clarify the Deadline for Submitting Certifications for Delayed Submission of Results Information: The Frequently Asked Questions (FAQs) page has new and updated content under the Results Information and Submission Deadlines section:
The below update was posted on the What’s New section of ClinicalTrials.gov, on December 22, 2020:
- Race and Ethnicity Reporting for Clinical Trials in ClinicalTrials.gov and Publications: A brief communication, “Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications,” was recently published in Contemporary Clinical Trials and is now available in Selected Publications.
- NIH-Funded Basic Experimental Studies with Humans Registration and Results Reporting Webinar Recording Available: The slides and recording are available on the Support Materials page from the December 7, 2020 webinar summarizing findings from NLM’s analysis of challenges in registering and reporting results information for Basic Experimental Studies with Humans (BESH) on ClinicalTrials.gov and issues to consider.
The below updates were posted on the What’s New section of ClinicalTrials.gov, on December 08, 2020:
- New Advanced Search Feature: The ability to search for study records with Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801) Violations is available in Advanced Search and an accompanying definition for ‘FDAAA 801 Violations’ is now available in the Glossary. NLM adds FDAAA 801 Violations to study records after this information is provided by the FDA.
- New Study Design Examples: The Training Materials page has two new study design examples for results data entry, Micro-Randomized and Sequential, Multiple Assignment, Randomized Trial (SMART).
The following update was posted on ClinicalTrials.gov What’s New Section, on November 10, 2020: