On November 28, 2019, a new version of the Clinical Trial Application form was launched, as referred in EudraLex. Updates regard the footnotes section. This does not have an impact on the clinical trial application form that is created through this website, since footnotes are not included in it.
What’s New section of the ClinicalTrials.gov was updated with the following post on December 17, 2019:
- Implementation Update on Changes to Posting Procedures for Applicable Clinical Trials: The Training Materials and Final Rule (42 CFR Part 11) Information pages have been updated to specify the implementation date for the change in procedures to meet the requirement to post results information for applicable clinical trials within 30 days of submission. As of January 1, 2020, initial results submissions for applicable clinical trials that do not meet quality control criteria will be publicly posted on ClinicalTrials.gov with brief standardized major comments. Also available is the Major Comments List containing the complete list of brief standardized major comments that may be provided to the responsible party by National Library of Medicine staff during the quality control review conducted to identify apparent errors, deficiencies, or inconsistencies in a submitted study record.
- New England Journal of Medicine Article on Results Information Submission: This article describes the current requirements, challenges, and opportunities for results information submission, 10 years after the ClinicalTrials.gov results database was launched. This and other publications by ClinicalTrials.gov staff are available on the Selected Publications page.
ClinicalTrials.gov PRS posted following update on December 30, 2019:
Changes to Posting Procedures for Applicable Clinical Trials
Consistent with requirements under 42 CFR 11.52, NIH must post results information for applicable clinical trials (ACTs) on the public website within 30 days of submission, regardless of whether the quality control (QC) review process is complete. For more information, see the Final Rule (42 CFR Part 11) Information page.
As of midnight EST (05:00 UTC), January 1, 2020, initial results submissions for ACTs that do not meet QC criteria will be posted publicly on ClinicalTrials.gov along with the brief standardized major issues. For details on the new procedures see the ClinicalTrials.gov Webinar: Updated Quality Control and Posting Procedures.
Major Comments List
The complete list of ClinicalTrials.gov Major Comments (issues) that may be provided to the responsible party by National Library of Medicine staff during QC review is now available on the ClinicalTrials.gov public website. This list will be updated as major comments are added or retired from use.
ClinicalTrials.gov updated the What’s New section on January 7, 2020, with the following update :
- ClinicalTrials.gov Modernization RFI: The National Library of Medicine (NLM) has issued a Request for Information (RFI) seeking public input to guide us in planning infrastructure enhancements aimed at ClinicalTrials.gov users and submitters as part of a multi-year modernization initiative. For more information on opportunities to engage with us to enrich and modernize ClinicalTrials.gov, see this guest post on the NLM Musings from the Mezzanine blog.
- Webinar on ClinicalTrials.gov Modernization and How to Provide Input: Join us for a webinar on January 22, 3:30-4 pm ET, about ClinicalTrials.gov Modernization. Register 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.
Following updates were posted on ClinicalTrials.gov, on January 29, 2020:
- Modernization Webinar Materials Available: A recording of the January 22 webinar and slides have been added to the ClinicalTrials.gov Modernization page.
- New Advanced Search Fields: Two new fields have been added to the Advanced Search page: Results First Posted and Results Submitted. Results First Posted can be used to find studies based on the date summary results were first available on ClinicalTrials.gov. The Results Submitted field can be used to find study records based on whether the study sponsor or investigator has submitted summary results information and if submissions with QC comments are available.
- National Library of Medicine Technical Bulletin Article on Updated Posting Procedures: This article highlights key features of the recent updates to ClinicalTrials.gov procedures for posting results information submitted for applicable clinical trials.
EudraCT has posted below notification:
As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.
The transition period began on 1 February 2020 and is due to end on 31 December 2020.
ClinicalTrials.gov PRS posted following updates for February 13, 2020:
PRS Guided Tutorials: Registration Coming Soon, Tutorials Will Replace PRS Help
Registration content will be added to the PRS Guided Tutorials in early March. At that time, links to the tutorials will replace the current Help content available through PRS module help pages. We will continue to collect feedback on the PRS Guided Tutorials through a survey, intended to help us develop improved content and features.
Provide Your Comments to the ClinicalTrials.gov Request for Information
The National Library of Medicine is requesting public comment to guide efforts to enhance and better support the users of ClinicalTrials.gov, particularly within the following topic areas: Website functionality, information submission processes, and use of data standards. For consideration, your responses must be received electronically by March 14, 2020 using the web-based form linked from the Request for Information.
Court’s Ruling Requires Government to Post A Decade’s Worth of Clinical Trial Results
As per the news published on YLS Today on February 25, 2020, a ruling from a federal judge will dramatically expand the public’s right to access results of clinical trials studying drugs and medical devices.
Judge Naomi Reice Buchwald of the Southern District of New York held that the Food and Drug Administration (FDA), National Institutes of Health (NIH), and Department of Health and Human Services (HHS) have misinterpreted a 2007 law that requires drug companies, universities, and other sponsors of clinical trials to disclose the results of clinical trials of FDA-approved products to the public via the ClinicalTrials.gov website. The court’s order requires the government to collect and post about a decade’s worth of trial results that should be public under the 2007 law — making data from potentially hundreds of clinical trials available for the first time. Continue reading “February 2020: United States Update”
As explained by Lene Grejs Petersen of the Danish Medicines Agency (DKMA), sponsors that fail to report clinical trial results will soon face fines or even prison sentences.
Under the current legal framework in Denmark, sponsors that fail to report results on time can be fined or given a prison sentence of up to four months. However, DKMA cannot issue fines by itself. Instead, the regulator has to go through the public prosecutor. Going forward, DKMA has decided to make use of this legal basis.
To clarify responsibilities, DKMA has made clear that it is sponsors’ responsibility to upload their trial results. Sponsors can do this directly. There is no requirement to additionally submit results to the medicines agency, which avoid needless duplication of effort. The sole exception to this rule are Phase I trials; because their results are not made public, they still need to be submitted to DKMA.
Click here to find the original article.
Clinical Trials Information System (CTIS) development
In December 2019, EMA’s Management Board endorsed to commence the audit of the system in December 2020, following an audit readiness assessment carried out by the nominated product owners, EMA and the IT supplier.
The aim of this assessment was to identify critical business blockers and resulted in an updated plan outlining items that still need to be developed or fixed for audit. The product owners will work with EMA and the IT supplier to analyse and design these items in the first few months of 2020, in a way that ensures efficient delivery.
The latest release of the system, which was validated by the nominated product owners in December 2019, enhances CTIS functionalities for processing the evaluation of clinical trial applications, data submission and view of data, management of user access, users’ oversight of activities and data transparency. These enhancements relate mainly to the authority and sponsor workspaces in the system.