December 2022: Germany Regulatory Update

An announcement was published on December 15, 2022, on the BfArM website regarding the notification of observational studies according to section 67 para. 6 of the Medicine Act (AMG) and on the non-interventional safety studies according to section 63f AMG.

As per the section 67 and section 63 of AMG regulation, there is an obligation to report the post-marketing observations and non-interventional safety studies (PASS) to the competent higher federal authority without delay. The German Medicine Act has increased the scope of reporting non-interventional safety studies, now the obligation to notify is not limited to studies that prospectively collect primary data, but also includes registers, retrospective studies, secondary data analysis and cross-sectional studies.

Safety studies that were started by October 26, 2012 are to be classified as observational studies and would continue to fall under the regulations of Section 67 Paragraph 6 AMG with regard to the notification and transparency obligations.

More information on this announcement can be found here.

December 2022: What’s New on ClinicalTrials.gov

On December 19, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

ClinicalTrials.gov Beta Website:

Prerecorded demonstration videos presenting features of PRS Beta and ClinicalTrials.gov Beta and highlighting changes from the classic sites are now available.

New search features, Improvements and bug fixes are added to make the  ClinicalTrials.gov Beta website more user-friendly.

The key features include:

    • Streamlined Homepage to enhance search experience
    • Provision to ‘Add All Filters’ or ‘Reset to Default’ can be accessed by the  Advanced filter dropdown
    • The record history tab has been included in the study records to view a study record’s history of changes. The elements in the study record versions that have changes are highlighted.
    • The dates have been reformatted  from month, day, year (Month DD, YYYY) to year, month, day (YYYY-MM-DD) format.

Moreover, the draft version of the new application programming interface (API) to support the beta website will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

December 2022: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on December 15, 2022:

Users can now view and edit the Study Status module, the IPD Sharing Statement module, and the Conditions module. These modules have new or updated onscreen guidance, slide-out drawers that provide additional help, and content relevant to the selected Study Type. Validation errors will also appear on the top of each module. This release also includes various bug fixes.

The key features include:

  • Addition of an onscreen introductory guidance in the IPD sharing statement section to encourage the inclusion of complete information.
  • Conditions and Keywords can now be added using a single text box. Each entered term will be displayed individually and can be viewed and removed easily

Moreover, in the future,  the text field will be responsive to the MeSH (Medical Subject Headings) thesaurus. It will search for terms found in MeSH and present matches to select from. In addition, the field will separate conditions found in MeSH from conditions that are not.

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December 2022: What’s New on ClinicalTrials.gov

On December 07, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

Webinar on ClinicalTrials.gov Modernization and Beta Website Progress

The recording and slides for the ClinicalTrials.gov Modernization and Beta Website Progress webinar conducted on October 27, 2022, have been added to the ClinicalTrials.gov Modernization page. The webinar featured an update on the modernization effort and a demonstration of the ClinicalTrials.gov Beta and Protocol Registration and Results System (PRS) Beta websites.

Additionally, the Report that presents an update on the ClinicalTrials.gov Beta and PRS Beta websites, future modernization activities, and more, is accessible.

November 2022: Germany Registry Update

Upgrade of German Clinical Trials Register (DRKS) Website

The website for the German Clinical Trials Register (DRKS) has been updated and is active since November 29, 2022.

Existing users will receive an email titled “Your DRKS user account” from [email protected] requesting them to setup a new password while logging in for the first time. As usual, new users can register in the study entry and registration area.

For any further queries, please contact the Technical Helpdesk.

November 2022: Germany Call for Extension, Owing to EU CTIS Functional Problems

An article “Massive functional problems of the EU portal CTIS for clinical trials threaten drug research in Europe“, was published on the Bundesverband der Pharmazeutischen Industrie (BPI) website on November 28, 2022, by the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK).  A similar article was also published on the sueddeutsche zeitung website on December 01, 2022.

German Pharma trade organizations, association of ethics committees, and applicants from academic research have drafted a letter requesting an extension to the transitional period for EU CTIS pursuant to Article 98 (2) of Regulation 536/2014, expiring on 31 January 2023.

The letter raises concerns associated with the functionality and shortcomings of the CTIS portal. The thorough review of research proposals by ethics committees is severely hampered by the dysfunctional nature of the portal. Due to such issues, the application for clinical trials and their processing by the ethics committees are massively impaired and cannot be managed. Also, this would have negative consequences on early access to new therapies for patients in Germany and the European Union.

The signatories to the letter consider it essential that the transition be extended until the EU CTIS portal is well established. The federal government is also urgently requested to bring about such an extension in a timely manner together with other EU member states.

November 2022: What’s New on ClinicalTrials.gov

On November 17, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

ClinicalTrials.gov Beta Website:

New search features, Improvements and bug fixes are added to make the  ClinicalTrials.gov Beta website more user-friendly.

The key features include:

    • In addition to expanded tabular view of search results, the card view of search results is also added.
    • Users can also select and reorder the columns displayed onscreen.
    • Printer-friendly layouts for selected study records have  been included
    • Navigation and accessibility for both the desktop and mobile versions of the website have been enhanced

Moreover, the feature for ‘Study record history’ will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

November 2022: What’s New on ClinicalTrials.gov PRS Beta Test System

The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on November 10, 2022:

Updates have been made to the PRS Test system to include two modules in the Protocol Section. These redesigned modules include on-demand help tips and guidance to make the data elements more understandable.

The key features include:

  • Users can create a new record and edit the Study Identification and Study Description modules of the Protocol Section.
  • More accessible and understandable help content for protocol data elements have been added.
  • Users can now access modules in any order they choose once the record has been created.

Detailed information on the updates can be found at here

 

October 2022: What’s New on ClinicalTrials.gov

On October 06, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

Webinar on ClinicalTrials.gov Modernization and Beta Website Progress

The webinar will be held on October 27, 2022, from 1.00 to 2.00 pm Eastern Time. It will provide an update on the progress of the modernization effort and an overview of the Beta ClinicalTrials.gov website and Protocol Registration and Results System (PRS) Beta. Advance registration can be done on the Webinar registration page.  A recording of the event will be made available for those who cannot attend the live event.