EU Launches Two New Pilot Programs Amidst Activation of Transparency Regs
The European Medicines Agency (EMA) is continuing efforts to improve trials in the trade bloc, announcing two new programs that will offer support on clinical trial applications as new transparency rules under its Clinical Trials Information System (CTIS) come into effect.
The rules, which became active on June 18, require sponsors to publicly post details about authorized trials earlier on CTIS, doing away with a deferral process that enabled sponsors to delay the publication of certain data and documents to shield commercially confidential information for up to seven years after trial closeout. The agency has issued a user guide to help sponsors comply with the new rules.
“The updated rules strike a balance between transparency of information and protection of commercially confidential information,” the EMA said. “They benefit patients because key clinical trial information that patients flagged as being most relevant for them is published early.” They also introduce simplified processes that benefit sponsors.
“Finally, they benefit healthcare professionals because the resulting system is more user-friendly, facilitating access to information on clinical trials and enrollment in clinical trials and also increasing awareness of possible treatment options.”
According to the EMA, the rules have made approximately 4,000 trials publicly accessible through the CTIS’ search function. Approximately 500 newly approved trials will be added to the system each month, including ongoing trials that were moved over to CTIS from the now-defunct Clinical Trials Directive system. In addition, the CTIS will see additional functionalities added “over the next few months,” the agency said.
The first pilot program will deliver scientific advice to sponsors on trials and direction on marketing authorization application requirements, while the second will provide technical and regulatory help on clinical trial agreement (CTA) dossiers before filing in the CTIS, including CTA dossiers for trials with decentralized components or complex designs.
The EMA also issued its yearly activity report for 2023 this month, recapping notable achievements. For example, the report underscores the agency’s efforts to utilize real-world evidence (RWE), noting that the EMA identified 61 research opportunities, launched 30 studies and completed 27 studies in this space from September 2021 to February 2023.
In addition, the DARWIN EU network, a platform to generate RWE in support of scientific decisionmaking, brought in 10 additional data partners and performed a significantly greater number of studies compared to 2022. By 2025, the EMA expects this platform to be fully operational and running approximately 150 studies annually.
Access the EMA’s user guide on the new rules here.
Access the EMA’s 2023 activity report here.
Learn how to apply to the first pilot here.
Learn how to apply to the second pilot here.
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