EMA official updates on EU clinical trial transparency rules

San Diego – The EU’s updated clinical trials portal, along with new transparency rules that require sponsors to list information on their trials in the Clinical Trial Information System (CTIS), went into effect on 18 June. Under the new rules, information on 4,000 clinical trials will now be publicly available, announced Ana Zanoletty Perez, head of the clinical trials transformation workstream for the European Medicines Agency (EMA), at the DIA 2024 Global Annual Meeting.

The session focused on the European clinical trials environment under the Accelerating Clinical Trials (ACT EU) initiative. At the meeting, a representative of a US-based patient group supported the ACT EU initiative and the CTIS as a move in the right direction.

Zanoletty also discussed some other activities EMA is undertaking to improve clinical trial data in the CTIS, including a recent two-day workshop January 2024 on the data analytics used in the CTIS. Some of the key conclusions in the workshop were the desire for improved access and more detailed and up-to-date clinical trial data, having patients actively involved in collecting this data, having the right data sources, and standardizing clinical trial data. EMA's next steps are to develop a document outlining shared research priorities to maximize the value of clinical trial data and institute specific research projects to optimize the use of such data.

The CTIS portal was launched in January 2022 as a main priority of the ACT EU initiative to transform how clinical trials are initiated and run. It was meant to prompt clinical research in the region and to address the lack of multi-state clinical trials in Europe during the COVID-19 pandemic. (RELATED: EU launches clinical trials transformation initiative, Regulatory Focus 18 January 2022)

Clinical trial sponsors must now use the portal to apply for authorization to run a new trial. Sponsors must transition ongoing trials to the new portal by 30 January 2025.

Under the EU’s revised transparency rules, which were published in October 2023 as a core part of the CTIS, the public will have access to clinical trials sooner; the former rules allow sponsors to delay the publication of certain data for seven years.

According to EMA, the legal basis for CTIS transparency rules under Recital 67 states that the information in the EU database should be public, unless sponsors request certain information not be published. Sponsors, for example, can request that certain information be redacted on grounds of confidentiality; this can include protecting personal data or protecting confidential communication between Member States in the preparation of an assessment report.

EMA has advised sponsors to submit their applications to the CTIS portal as soon as possible and noted at a recent meeting that sponsors have moved only 20% of clinical trials to the new platform.

At the meeting, a representative of a patient group supported the EU’s ACT Initiative and the CTIS as a move in the right direction. “As I was polling everyone on ACT EU, both US and EU patient advocates, everyone felt that overall, it was a good plan and that it had been well thought. The multi-stakeholder involvement is important, and of course in that is when we talked about patients, the hope is that everyone is included, such as health care provider and patients because are symbiotic twins, we cannot have one without the other,” said Deborah Collyar, president of Patient Advocates in Research (PAIR).

DIA Global Annual Meeting

EMA official updates on EU clinical trial transparency rules

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