EMA reports slow uptick in clinical trial applications submitted via CTIS portal

Regulatory NewsRegulatory News | 03 August 2022 |  By 

The number of applications filed through the Clinical Trial Information System (CTIS) portal continues to grow, even while most applications are still being filed in the current EudraCT system, according to a 28 July report from the European Medicines Agency (EMA).  Stakeholders offered a mixed assessment of their user experience at recent forum.
Starting in January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors must use the CTIS portal to apply for authorization to run a clinical trial. The CTIS portal was launched in January, and registration is still voluntary (RELATED: EMA readies CTIS go-live plan, Regulatory Focus, 8 October 2021).
The benefits of CTIS are improved information sharing and collective decision-making on clinical trials, increased transparency on clinical trials, and ensuring high safety standards for patients, according to EMA.
According to the report, 133 clinical trial applications were registered with CTIS since the launch of the portal on 31 January. There has been a slow but steady increase in applications, from nine in February 2022, 18 in March, 29 in April, 36 in May, and 41 in June.
Twenty-four decisions have been made on these 133 applications. Of those, 14 applications were filed by academic sponsors or hospitals and 10 by commercial sponsors.
In the same time period, 943 applications were  submitted through the EudraCT pathway, according to the report. There has been a steady decrease in the number of applications filed with EudraCT, from 200 in March 2022, to 87 in April, to 178 in May to 175 in June.
Stakeholders offer mixed assessment of CTIS
At a 1 July webinar and stakeholder meeting  on CTIS, Members State representatives and sponsors shared their experiences with the portal.
“Our experience is that processing of applications in CTIS is efficient,” according to Outi Konttinen, general secretary and group leader for Finland’s National Committee of Medical Research Ethics (Tukija). So far, seven applications have been submitted that concern Finland.
What is unclear about the system is whether additional requested information should be submitted via CTIS or separately via email, she said, adding that it would be helpful to have a general chat function in place to ease the communication with sponsors.
Gabriella Di Matteo, clinical trial applications manager for Pfizer in Belgium, said while some elements of the portal worked, others did not. The company has so far submitted two applications through the portal, one multistate application and one to a Member State.
She said that uploading documents and downloading the application went well. However, she said there were problems in updating some documents. She added that “additional resources” are needed for companies to effectively use the system.
Thale Patrick-Brown, of Oslo University Hospital in Norway, offered a mixed assessment.  The institution is developing a multi-center pan-European clinical trial platform for a COVID-19 drug. On the plus side: the system is transparent, and it is efficient to have one portal to register all information, including drug information and ethics information, as well as have fixed timelines for approval.
Yet the portal is not designed to accommodate platform trials. For example, each new arm and investigation must be entered as a brand-new trial. This means that in many countries, companies still must pay full fees for every arm of the study, instead of just paying an update fee.
EMA report on KPIs
EMA webinar and stakeholder meeting


© 2023 Regulatory Affairs Professionals Society.

Tags: clinical, CTIS, EMA, trials

Discover more of what matters to you