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.
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 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.
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 PRS test, expected to go live on ClinicalTrials.gov PRS on February 01, 2021:
- Delayed Results and Results Expected Details
Responsible parties may now only submit certifications for delayed submission of results information prior to the date of (i.e., the day before) the standard submission deadline for results information. The standard submission deadline for results information is no later than 1 year after the ACT’s primary completion date. Related details have also been added to Results Expected date.
- Field Length Change
Maximum field length has been increased to 500 for the Results Participant Flow:Period(s):Milestone:Data:Comments field to make it match the allowed length in the Participant Flow:Period(s):Milestone:Comments field.
- Review History Download
For administrators, Review History information for all of an organization’s records can now be downloaded as comma-separated values (CSV) for input to spreadsheet applications such as Excel. This function is accessed via the PRS Home page Records menu.
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:
Below updates were posted on ClinicalTrials.gov What’s New section, on October 01, 2020:
- Regarding Submission of Results Information: The History, Policies, and Laws and Frequently Asked Questions pages have been edited to provide further clarity to responsible parties on the Federal Court Decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020).