WHO’s primary registry designation for CTIS a boost for EU trials, says EMA

The WHO has designated the EU Clinical Trials Information System (CTIS) as a primary registry in a move that will make publishing results easier for sponsors and CROs.

The designation means the CTIS complies with WHO standards for content, data quality and validity, accessibility, unique identification, technical capacity, and administration.

In addition, the CTIS will meet standards set by the International Committee of Medical Journal Editors (ICMJE), which is a prerequisite for clinical trials to be published in general medical journal articles.

An EMA spokesperson told Clinical Insider, “The designation of the CTIS as a WHO primary registry promotes trust in clinical research and reinforces EMA’s commitment to transparency, which is a fundamental feature of the Clinical Trials Regulation.”

The spokesperson added, “Information on more than 8,900 clinical trials currently available on the CTIS public website is now also visible on the WHO’s International Clinical Trials Registry Platform (ICTRP).

“Being part of the ICTRP network ensures that CTIS meets the standards set by the International Committee of Medical Journal Editors, which is a prerequisite for clinical trials to be published in general medical journal articles. This reduces the burden on sponsors and prevents the need to register clinical trials in additional ICTRP primary registries,” the spokesperson continued.

The designation also means the CTIS, which was launched in 2022, is now on the same level as the system it replaced — the EU Clinical Trials Register — which was named as a WHO primary registry in 2011.

Currently, there are 18 members of the WHO’s primary registry network, including databases in Australia, Brazil, South Korea, India, and Japan.

News of the designation comes weeks after the EMA cited the CTIS as key to its efforts to make the EU more attractive for trials in its 2028 strategy document.

“The Clinical Trials Information System remains an essential tool for implementing the Clinical Trials Regulation, supporting Europe as a key destination for clinical trials. Ongoing efforts will focus on simplifying, modernizing, and improving the system’s user experience,” the EMA wrote.

This point was reiterated by the spokesperson, who told us, “Becoming a primary registry also means that the CTIS adheres to specific criteria for data quality and accessibility, ensuring additional visibility of EU clinical trials globally.”

DepositPhotos/thaneeh.gmail.com