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.
Implementation of UK HRA’s New Reporting Standards for Clinical Research
As per the latest update from UK Health Research Authority, new reporting standards have been implemented to ensure that all researchers fulfill their responsibilities to make their research open and transparent. This is in line with the commitments set out in the Make it Public research transparency strategy.
From Wednesday 15 September health and social care researchers are expected to submit information at the end of their research study to the HRA online, explaining how they have fulfilled their transparency responsibilities. This is part of a set of changes which make it easy for researchers to be transparent and enable the HRA to know whether they are meeting the requirements.
This will also enable to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).
In order to standardize the information submission, a New Final Report Form had been published.
The European Commission has published the decision (L275) in the Official Journal of the European Union, today (July 31, 2021) announcing that the EU portal and the EU database have achieved full functionality and meet the functional specifications, as referred to in Article 82(2) of Regulation (EU) No 536/2014. This Decision shall enter into force on the day of its publication in the Official Journal of the European Union (31 July 2021).
On 21 April 2021, the Management Board of the Agency, on the basis of the independent audit report delivered on 8 April 2021, informed the Commission in accordance with Article 82(2) of Regulation (EU) No 536/2014 that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications published by the Agency.
On the basis of the information provided by the Management Board of the Agency, the Commission verified that the EU portal and the EU database fulfilled the conditions of the full functionality and of compliance with those functional specifications. For more details, please refer to the Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council.
The third issue of CTIS Highlights was published on June 23, 2021.
It discusses two user management approaches (organization-centric and trial-centric) and the process of assigning roles in CTIS.
The other topics covered are CTIS system functionalities, Initial clinical trial application process in CTIS, Training Programme update and Audit updates. Additionally, it announces the availability of a CTIS Sponsor Handbook. EMA, in a collaborative approach including sponsor representatives, will prepare a sponsor handbook to provide sponsors with an overview of materials available to help them prepare for and use CTIS. A first version is expected to be published in Q3 2021.
A new document, Guide to CTIS training material catalogue, is made available on June 23, 2021, on the EMA’s Clinical Trials Information System (CTIS): training programme page. It includes an overview of available and planned training modules. It also outlines the life-cycle stages of a clinical trial, with reference to the relevant training modules in each stage.
EMA published the highlights from June 2021 Management Board meeting on June 18, 2021. Below is the update posted regarding EU CTIS:
Progress on EU IT systems required by the Clinical Trial Regulation
The Board welcomed the progress in the development and preparations for ‘go-live’ of the Clinical Trial Information System (CTIS). Following the independent audit reported in April 2021 and the endorsement on full functionality of CTIS by the Board, the publication of the Commission decision is anticipated for 31 July 2021 in the Official Journal of the European Union and go-live is currently on track for 31 January 2022.
The development of CTIS continues as planned and EMA, together with Member States and sponsor experts, are heavily engaged in working on the agreed functionalities for the go-live version of the system.
More information can be found here.
The Medical Device Coordination Group (MDCG) published a document FAQ on the European Medical Device Nomenclature (EMDN) on June 04, 2021.
The EMDN aims at supporting the functioning of the European database on medical devices (EUDAMED). It will be utilized by manufacturers for the registration of medical devices in EUDAMED, where it will be associated to each Unique Device Identifier – Device Identifier (UDI-DI). The document answers questions about the creation, access and structure of the EMDN.
The full list of EMDN V1.0.0 is available at https://webgate.ec.europa.eu/dyna2/emdn/. The second version will be released in Q3 2021.
The article, European regulators mull ways to improve trial reporting, was published on TranspariMed on June 02, 2021.
The discussions are initiated by the European national regulators, the European Medicines Agency and the European Commission after a letter was sent on behalf of 18 European civil society groups to Heads of Medicines Agencies (HMA), in which HMA was asked to ensure that all national medicines regulators in Europe directly contact all trial sponsors that have left results unreported. This was one of the 4 common standards suggested in this letter.
As a response, HMA mentioned that they are not in a position where the organization can impose standards on the national competent authorities, however, they will reach out to the European Commission and the European Medicines Agency with a view to initiate joint actions to improve clinical trial sponsors’ compliance with CTIMP results reporting requirements.
The United Kingdom’s National Institute for Health Research (NIHR) Innovation Observatory has launched ScanMedicine, a searchable database of global clinical trials, for use by researchers, clinicians, and the public.
ScanMedicine is free to access, draws data from 11 major clinical trial databases around the world, including US ClinicalTrials.gov, and features data on medical devices, diagnostics, and digital apps.
The tool collates and presents the latest data in a readily accessible format, enabling users to filter results by trial type, phase, registry and more, as well as to view searches as visualisations and infographics for a ‘quick-look’ version of their results, identifying gaps and trends.
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.