The EMA has removed the ability for sponsors to defer trial data for seven years in a transparency update to its CTIS public portal.
The EMA has launched a new version of the CTIS public portal, which will allow for quicker and more efficient access to information about clinical trials being conducted in the EU for patients, healthcare professionals and other stakeholders.
Go deeper with GlobalData
This change is associated with revised transparency rules released by the agency on 18 June. The EMA launched a public consultation period on the rules in May 2023.
Senior pharmaceutical analyst for Clinical Trials Intelligence at GlobalData, Sonnika Lamont, said: “The industry is moving towards transparency with CTIS, the revised Good Clinical Practice guidelines, and hopefully with the new clinical trial legislation. Increasing transparency and sharing metrics and key performance indicators is the vital next step to move the industry forward and help us hold the systems accountable.”
One of the key changes eliminates the previously available deferral mechanism, which allowed trial sponsors to delay publishing certain data and documents for up to seven years after a trial’s completion to protect commercially confidential information.
The new rules mean that approximately 4,000 clinical trials with issued decisions that were previously unavailable are now publicly accessible to view on the CTIS.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe EMA says that it will add more features to the CTIS public portal to improve usability.
The EMA believes the updated rules will strike a balance between transparency of information and the protection of commercially confidential information.
The agency believes that the changes will benefit all parties – patients because key clinical trial information is published earlier; sponsors because they introduce process simplifications; and healthcare professionals because the system is more user-friendly, improving access to information on ongoing trials and enrolment as well as increasing awareness of possible treatment options.
The EMA has released a user guide and an overview of the changes under the transparency rules for sponsors to look over, and support activities are also being organised. The first event will be held on 20 June for sponsors, contract research organisations, small and medium-sized enterprises and academic organisations to attend.
The CTIS launched in January 2022 and sponsors have had to file new trials to the system since 31 January 2023. Sponsors must have transferred all trials, including ongoing trials, from the Clinical Trial Directive (CTD) to the CTIS by 31 January 2025. The EMA recommends that sponsors start this process before the end of October 2024 to ensure the file is active before the cut-off date.
