EU pharma understands CTR trial transparency rules, says EMA

Sponsors running drug trials in the EU understand their transparency obligations, according to the European Medicines Agency (EMA), which says concerns about sharing potentially sensitive information have been addressed.

Last week, the clinical trials information system (CTIS), an online database for the regulatory submission, authorization, and supervision of drug studies in the EU and the European Economic Area, became fully functional.

The development marked the end of a three-year transition period, during which 5,000 studies recorded in the previous system were transferred to the CTIS.

The CTIS will have an immediate impact on the transparency of drug trials, according to EMA press officer Salvador Ruiz Carrillo de Albornoz, who told Clinical Insider sharing information is key for public health.

“Making trial results publicly accessible provides valuable information on their outcomes. This transparency is crucial for the research community, healthcare professionals, and ultimately, for patients,” he said.

“Having access to the results of past trials helps future research to be more effective and diminishes research waste by providing important inputs based on past experiences. Healthcare professionals can obtain useful information on therapeutic options. Patients can also access trial results and consult their doctors accordingly.”

Transparency

Transparency is a key element of the Clinical Trials Regulation (CTR), the legal framework under which the CTIS was introduced. Indeed, under the CTR, trial sponsors have an obligation to post a layperson summary of the trial results in the database.

Marketing authorization holders must also post clinical study reports for studies that have been authorized under the CTR.

Once posted, the summary results are publicly available in line with the CTIS transparency rules and Art. 81(4) of the CTR, which states that information on trials should be publicly accessible.

Industry understanding

In the years since the CTIS was established, considerable effort has been made to make sure the drug industry understands what is expected of it in terms of transparency.

For example, the EMA offers an online modular training program and a CTIS Sponsor Handbook, alongside other supportive materials.

Ruiz Carrillo de Albornoz told us, “The EMA has put a lot of effort into raising awareness of CTIS reporting requirements and sponsors are well aware of these resources.”

When the CTIS was rolled out, some in industry raised concerns the publication rules would force them to share information that would aid rival developers.

The EMA has also worked to reassure industry, Ruiz Carrillo de Albornoz said, adding “the CTR which also recognizes that commercially sensitive information needs to be protected due to confidentiality.

“Sponsors are, therefore, required to submit all documents, including summary of results documents, in CTIS in two versions: one ‘for publication’ and the other ‘not for publication,’” he said.

“In the document version ‘for publication,’ sponsors should protect any information that is commercially confidential, as well as any applicable personal data, so that no concern on making confidential information public is raised.”

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