December 2021: What’s New on ClinicalTrials.gov

On December 22, 2021,  ClinicalTrials.gov  updated the materials for Modernization and Beta Website webinar: A recording of the December 10, 2021 webinar and slides describing the launch of beta ClinicalTrials.gov and demonstration have been added to the ClinicalTrials.gov Modernization page. This webinar provides an update on the modernization effort and a demonstration of the beta ClinicalTrials.gov website.

December 2021: What’s New on ClinicalTrials.gov

ClinicalTrials.gov Beta Website

On December 08, 2021,  ClinicalTrials.gov posted an update announcing the first release of the beta ClinicalTrials.gov website and it can be accessed at: ClinicalTrials.gov beta website. More information on the new features that the website provides can be found at: NLM Technical Bulletin.

Also, PRS Beta will be released to the PRS Test system in early 2022, giving users an opportunity to explore the new PRS experience, performance of new technology, and to provide feedback to help improve future PRS Beta releases.  A recorded demonstration to preview PRS Beta is now available.

December 2021: What’s New on ClinicalTrials.gov

Webinar on ClinicalTrials.gov Modernization and Beta Website Demonstration

On December 02, 2021, ClinicalTrials.gov posted an update about the Webinar on ClinicalTrials.gov Modernization and Beta Website Demonstration. The webinar would be held on December 10, 2021, from 1.00 to 1.45 pm Eastern Time. The webinar would provide an update on the modernization effort and a demonstration of the beta ClinicalTrials.gov website. Registration can be done on ClinicalTrials.gov webinar registration page. A recording of the webinar and the presentation slides will be made available for those who cannot attend the live event.

November 2021: Transparency Scenario in Europe, United States and Canada

An article, Comparing regulatory transparency in Europe, United States and Canada, was published on TranspariMed on November 02, 2021.

This article, provides a comprehensive overview of the key laws and policies governing disclosure of data by major medicine regulators namely European Medicines Agency, the US Food and Drug Administration, and Health Canada. It also compares the data access provided to certain transparency documents by the regulators. This article was originally published by Cambridge university – Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration

According to the article, the three major medicines regulators are providing more access to key data than ever before. The study focuses on Clinical Study Reports, highly detailed documents that contain important information on the conduct and outcomes of clinical trials that cannot be found elsewhere, but also covers Individual Patient Data plus other types of data and documentation.

The key findings of the article are:

CLINICAL STUDY REPORTS

  • Redactions – The three regulators make only “minimal” redactions to Clinical Study Reports (CSRs) to remove commercially confidential information and data that may endanger patients’ anonymity. Those redactions “generally did not hamper the interpretation of evidence”.
  • Proactive disclosure – Only Health Canada and the European Medicines Agency proactively disclose new CSRs. While the Canadian regulator makes CSRs fully public, the European regulator places restrictions on who can access them, and how. The US Food and Drug Administration has yet to start proactively disclosing CSRs.
  • Reactive disclosure – All three agencies have mechanisms that allow researchers to gain access to older CSRs and other regulatory data upon request. Health Canada provides CSRs far faster and in a more accessible format than the other two regulators do.

INDIVIDUAL PATIENT DATA

Access to Individual Patient Data – Access to IPD via regulators is still impossible in practice. Only the US Food and Drug Administration releases IPD on request, but it when does so, it redacts the data so heavily that they are useless. The European Medicines Agency has formally committed to making IPD accessible in future, but this is not likely to happen any time soon. Health Canada does not have an IPD sharing policy.

ACCESS TO OTHER TYPES OF DATA

The three regulators differ widely in which other types of data they would release.

The article concluded that regulatory data pertinent to public health and clinical medicine, that were used to support the approval of medicines and medical devices are now available proactively or in response to information requests. Over the next decade, regulatory agencies should make Individual patient data available, and additional resources might be needed to ensure the long-term viability of regulatory data sharing programs and to encourage researchers to take advantage of the data that is — for now — more available than ever before.

More information can be found here.

October 2021: What’s New on ClinicalTrials.gov

On October 26, 2021, ClinicalTrials.gov updated about materials of modernization Webinar.  A recording of the October 7, 2021 webinar and slides describing the anticipated launch of beta ClinicalTrials.gov have been added to the ClinicalTrials.gov Modernization page. This webinar provides an update on modernization efforts and information on the anticipated launch of beta ClinicalTrials.gov.

October 2021: What’s New on ClinicalTrials.gov

Below update was posted on ClinicalTrials.gov What’s New section on October 08, 2021:

  • Train-the-Trainer Materials Available: The materials from the August 2021 Results Database Train-the-Trainer virtual workshop are now on the Training Materials page. The topics covered in the workshop included an Overview of the Clinical Trial Disclosure Landscape, a PRS System Overview, NIH Requirements for Clinical Trials Registration and Reporting, PRS Results Module Introductions, and Example Studies for Results Data Entry.
  • Glossary Term Updates: Definition for Results First Posted with QC Comments is now available in the Glossary and the terms, Results First Posted and First Posted, have been updated for clarity. In addition, the Results First Posted with QC Comments date is added to the ClinicalTrials.gov Key Record Dates.

October 2021: ClinicalTrials.gov Modernization Webinar Update

A Webinar on ClinicalTrials.gov Modernization took place on October 7, 2021.

A summary report on the progress in ClinicalTrials.gov modernization effort from August 2019 to August 2021 is now published by the National Institutes of Health (NIH). This report gives detailed insight into the National Library of Medicine (NLM’s) approach to modernization, presents the Working Group’s input on various aspects of the modernization effort, describes user challenges and modernization priorities by each strategic goal, also shares NLM’s product development plans and progress, and presents future steps for the Working Group and the modernization effort.

Concerning NLM’s product development plans, the first beta release of the PRS website is planned for late fall 2021. NLM’s next steps in ClinicalTrials.gov modernization involve seeking the Working Groups feedback and suggestions for functionalities to be added in future releases and to start public communications related to the beta release of PRS.

Additional information about the ClinicalTrials.gov modernization effort is available on ClinicalTrials.gov.

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.